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Background: Acupuncture is an effective complementary therapy for nausea and vomiting during pregnancy (NVP). Nevertheless, the utilization of acupuncture for NVP has been minimally explored in current scholarly research, with a paucity of systematic randomized clinical trials (RCTs) in it. We aim to evaluate the effects of acupuncture on NVP after assisted reproductive techniques (ART) and explore the metabolism-related mechanism of the efficacy. Methods: This single-blind, randomized, controlled trial will randomize 68 patients with NVP after ART to a traditional acupuncture (tACP) or a sham acupuncture (sACP) group. The tACP group will receive tACP thrice a week for 2 weeks with a day interval between sessions, while the sACP group will undergo the same number of nonpenetrative acupuncture at non-acupoints for the same period. Pregnancy-specific quantification of emesis will be used to evaluate symptom severity. Routine blood and urine tests, liver and kidney function tests, human chorionic gonadotropin, nuchal translucency thickness, and embryonic development measured using ultrasound will be used to evaluate safety during pregnancy. Non-targeted metabolomic analysis will be performed to explore the association between metabolic changes and clinical symptoms. Discussion: This study will elucidate the effects and safety of acupuncture in treating NVP in women undergoing ART. The results of this study will contribute to optimizing acupuncture therapies by combining the body and auricular points and exploring the underlying therapeutic mechanism using a metabolomics approach. Trial registration: Chinese Clinical Trial Registry, ChiCTR2300075259. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Clinical Nursing in Practice is the property of Journal of Clinical Nursing in Practice (Editorial Board, Shanghai Jiao Tong University Press) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Purpose: Chemotherapy-induced nausea and vomiting (CINV) is a common adverse events in cancer patients and can negatively affect their quality of life (QoL). This study aimed to evaluate the clinical efficacy of an electric massage chair (EMC) for the treatment of CINV. Methods: A randomized phase II cross-over trial was conducted on solid cancer patients who received moderate (MEC) to high emetogenic chemotherapy (HEC). The participants were randomly assigned to receive their first chemotherapy either on a standard bed (Group A) or in an EMC (Group B) during the infusion. The patients were then crossed over to the next cycle. CINV and QoL questionnaires were collected from the participants. Results: A total of 59 patients completed the trial protocol and were included in the analysis, with 29 and 30 patients in Groups A and B, respectively. The mean INVR (Index of Nausea, Vomiting, and Retching) score in the 2nd day of the first cycle was higher in Group B (3.63 ± 5.35) than Group A (2.76 ± 4.78), but the difference was not statistically significant (p = 0.5367). The complete response rate showed little difference between the groups. Among the high-emetic risk subgroups, patients who received HEC (p = 0.04595), younger patients (p = 0.0108), and non-colorectal cancer patients (p = 0.0495) presented significantly lower CINV scores when EMC was applied. Conclusion: Overall, there was no significant difference in INVR scores between standard care and EMC. Applying EMC at the first chemotherapy infusion may help preserve QoL and reduce CINV in high-risk patients. Trial registration: KCT0008200, 17/02/2023, Retrospectively registered. [ABSTRACT FROM AUTHOR]

Aims Studies conducted in the field of non-pharmacological interventions to control acute and delayed nausea and vomiting caused by chemotherapy have reported contradictory results. The present study aimed to compare the effect of ice massage and C-band on acute and delayed nausea and vomiting caused by chemotherapy in cancer patients. Materials & Methods In the present clinical trial study, 105 patients referred to the chemotherapy department of Shahid Rajaei Hospital, Yasuj, Iran in 2018, were selected by convenience sampling and randomly assigned to three groups: Ice massage, C-band, and control. Acute nausea and vomiting was assessed through the Morrow Assessment of Nausea and Emesis, and delayed nausea and vomiting were assessed using the MASCC tool at 6, 12, 18, and 24 hours after chemotherapy, before and after the interventions. The collected data were analyzed using SPSS 22 software. Findings Before intervention, there was no significant difference in terms of the presence/ absence, as well as the intensity of acute and delayed nausea and vomiting in the three groups at 6, 12, 18, and 24 hours after chemotherapy (p>0.05). Also, after the interventions, there was no significant difference in the presence/absence and intensity of acute and delayed nausea in the patients in the ice massage, C-band, and control groups at 6, 12, 18, and 24 hours after chemotherapy (p>0.05). Conclusion Ice massage and C-bandage do not improve nausea and vomiting in chemotherapy patients. [ABSTRACT FROM AUTHOR]

Copyright of Journal of Clinical Nursing in Practice is the property of Journal of Clinical Nursing in Practice (Editorial Board, Shanghai Jiao Tong University Press) and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Background: Complementary and integrative medicine may be effective for postoperative outcomes. This study aimed to determine the effect of lemon inhalation aromatherapy on pain, nausea, and vomiting and neurovascular assessment in patients for lower extremity fracture surgery. Methods: This is a randomized clinical trial study. Ninety patients who had undergone lower extremity fracture surgery were randomly assigned to the intervention (lemon aromatherapy) and control groups. Lemon aromatherapy was started in the morning of the surgery and extended at two-hour intervals until the end of the surgery, in the recovery room, and 16 h after surgery. Numerical pain and nausea and vomiting scales, the Rhodes Index of Nausea, Vomiting, and Retching, and the WACHS Neurovascular Observation Chart were used to assess the outcomes before and after the intervention (in the recovery room and 4, 8, 12, and 16 h post-surgery). The data were analyzed using the Wilcoxon test, ANCOVA, and Repeated Measure ANCOVA. Results: A significant difference was observed between the groups in terms of the intensity of pain (P < 0.001) and nausea and vomiting (P = 0.001) during the study period. Moreover, a significant difference was found between groups as to the frequency and severity of nausea, vomiting, and retching. The amount and duration of postoperative vomiting and nausea were significantly lower in the intervention group compared to the control group. In addition, lemon inhalation aromatherapy decreased the frequency of anti-emetic drug administration in the recovery room (P = 0.04) and 16 h post-surgery (P = 0.03). Conclusions: This study indicated that aromatherapy reduced pain intensity, postoperative nausea, vomiting, and retching, as well as the incidence of anti-emetic drug administration. Therefore, using lemon inhalation aromatherapy to relieve pain and reduce nausea and vomiting is suggested for lower extremity fracture patients who have undergone surgery. Trial registration: This study was registered in the Iranian Registry of Clinical Trail (Number = 57,331, IRCT20130616013690N10, approved 24/07/2021) (https://www.irct.ir/trial/57331). [ABSTRACT FROM AUTHOR]

This randomized controlled clinical trial aimed to examine the effect of spirituality-based palliative care on pain, nausea, vomiting, and the quality of life in 80 Iranian colon cancer inpatients from January to June 2020 in southern Iran. Patients were randomly assigned to an intervention group and a control group. The intervention group took part in four 120-min sessions while the control group received standard care. Pain, nausea, vomiting, and quality of life were assessed before the intervention and one month after the intervention. Data were analyzed using paired t-test and independent t-test. Between-groups differences analysis showed a significant difference in the quality of life scores, pain score, as well as nausea and vomiting scores following the one-month intervention. In conclusion, this group spirituality-based palliative care intervention might be beneficial in improving quality of life and reducing symptoms. [ABSTRACT FROM AUTHOR]

Background: Pregnant patients often seek natural remedies when they experience pregnancy-induced nausea and vomiting (PINV). Scant evidence exists to quantify the beneficial effects of essential oil inhalation as a remedy for PINV, yet is identified as a common integrative and complementary medicine treatment, particularly during the first trimester. The purpose of this trial was to evaluate the effects of aromatic essential oils on nausea, vomiting, and quality of life during the first 13 weeks of pregnancy. Methods: This was a 4-arm randomized, blinded, placebo controlled clinical trial to evaluate the potential of grapefruit, ginger, and peppermint essential oils on nausea, vomiting, and overall quality of life. Citrus paradisi is cold pressed from the citrus rind, Zingiber officinale is extracted from the root of the herb, and Mentha x piperita is extracted from the leaves of the plant. The essential oils were diluted in avocado oil for skin application. The placebo consisted of avocado oil. Participants were recruited through the research practice's database and completed the intervention in their own homes to mimic real world scenarios. Seventy-four pregnant women within their first trimester were randomized into four groups, including the placebo group. Results: Outcomes were measured using the Quantification of Emesis 24-hour scale (PUQE-24), a validated measurement of nausea, vomiting, and quality of life during pregnancy. All groups improved on all measures progressively during the trial. When placebo and intervention groups were compared, there was no significant difference between groups on sleep and nausea outcomes. Ginger essential oil was found to reduce retching and the use of aromatherapy in general improved well-being. [ABSTRACT FROM AUTHOR]

Context: Palliative care aims to improve the quality of life in patients with incurable illness. Medicinal cannabis (MC) has been used in the palliative care setting to address multiple symptoms in patients.Objectives: To evaluate the full scope of available literature investigating the effects and potential harms of MC on symptom management and quality of life in palliative care.Methods: PubMed, Embase, The Cochrane Library and clinicaltrials.gov were searched for eligible articles, published between 1960 and September 9, 2021. Quality of the evidence was assessed in accordance with Grading of Recommendations, Assessment, Development and Evaluations. Risk of bias was assessed using the RoB 2 tool for randomised controlled trials and the Risk of Bias in Non-randomized Studies-of Interventions (ROBINS-I) tool for non-randomized trials.Results: Fifty-two studies (20 randomised; 32 non-randomised) with 4786 participants diagnosed with cancer (n = 4491), dementia (n = 43), AIDS (n = 235), spasticity (n = 16), NORSE syndrome (n = 1) were included. The quality of evidence was 'very low' or 'low' for all studies, and low for only two randomised controlled trials. Positive treatment effects (statistical significance with P < 0.05) were seen for some MC products in pain, nausea and vomiting, appetite, sleep, fatigue, chemosensory perception and paraneoplastic night sweats in patients with cancer, appetite and agitation in patients with dementia and appetite, nausea and vomiting in patients with AIDS. Meta-analysis was unable to be performed due to the wide range of cannabis products used and the heterogeneity of the study outcomes.Conclusion: While positive treatment effects have been reported for some MC products in the palliative care setting, further high quality evidence is needed to support recommendations for its use in clinical practice. [ABSTRACT FROM AUTHOR]

Objective: We aimed to evaluate the effectiveness and safety of preoperative electroacupuncture (EA) on the incidence of postoperative nausea and vomiting (PONV), and severity of postoperative pain, in gynecological patients undergoing laparoscopic surgery. The effects of EA administered at different preoperative time points were compared. Methods: A total of 413 patients undergoing elective laparoscopic gynecological surgery were randomly allocated into 4 groups receiving EA the day before surgery (Group Pre, n = 103), 30 min before (Group 30, n = 104) or both (Group Comb, n = 103), or usual care alone (Group Usual, n = 103). All acupuncture groups had usual care. The incidence of PONV and pain at 24 h were primary outcomes. Secondary outcomes included the severity of postoperative nausea, vomiting and pain, requirement for antiemetic medication and quality of recovery (QoR)-15 scores after surgery. Results: There were significant differences between the four groups in nausea and vomiting incidence (0–24 h), postoperative antiemetic use (0–48 h), and postoperative pain (0–6 h), with the EA groups recording the lowest levels. Regarding primary outcomes, incidence of nausea and vomiting at 6-24 h was 28/11/18/11% (p = 0.003) 23/5/8/9% (p < 0.001), respectively, for Groups Usual/Pre/30/Comb. Accordingly, EA reduced the incidence of nausea and vomiting at 6-24 h by 61/34/60% and 79/65/61% for Groups Pre/30/Comb, respectively. Regarding secondary outcomes, incidence of nausea and vomiting at 0-6 h was 20/9/11/7% (p = 0.013) and 17/7/9/6% (p = 0.021), respectively, for Groups Usual/Pre/30/Comb. Rescue antiemetics at 0–6 h were required by 18/4/11/4% (p = 0.001) in Groups Usual/Pre/30/Comb. The mean numerical rating scale (NRS) pain score (0–10) at 0–6 h was significantly different between groups (2.45/1.89/2.01/1.97 for Groups Usual/Pre/30/Comb, p = 0.024). There were no significant differences between the three EA-treated groups. Conclusion: In gynecological patients undergoing laparoscopic surgery and treated with multimodal antiemetic methods, one session of preoperative EA may be a safe adjunctive treatment for PONV prophylaxis. Optimal timing of EA requires further verification. Trial registration number: ChiCTR-INR-16010035 (Chinese Clinical Trial Registry). [ABSTRACT FROM AUTHOR]

Nausea and vomiting have psychological negative effects on some pregnant women during gestation. Different strategies have been used for the treatment of nausea and vomiting during pregnancy, such as acupressure and psychological interventions. This study was conducted to evaluate the effects of psychological counseling and acupressure based on couple therapy procedures on vomiting and nausea in pregnant women in Iran. Two hundred and eight women were divided into four groups (n=52): 1) they did not any intervention (control group), 2) they received the psychological intervention, 3) they received acupressure intervention, and 4) they received a combination of psychological + acupressure interventions. To investigate the effects of interventions on nausea and vomiting, the Rhodes index of nausea, vomiting and retching were used. The counseling period has lasted for 4 weeks. The pressure intervention on the site was conducted in clockwise form for 1 min and anticlockwise form for another 1 min. Groups did not have a significant difference for abortion and income (p>0.05). The effects of counseling, and acupressure interventions on severity and period of vomiting and nausea were not significant (p>0.05), but the intervention based on counseling and acupressure decreased severity of vomiting and nausea (p<0.05). The intervention based on counseling and acupressure could not reduce nausea and vomiting during the gestation, but the intervention based on a combination of both decreased nausea and vomiting. It can be suggested to apply an intervention based on a combination of counseling and acupressure in short-time period for decreasing nausea and vomiting in women during pregnancy. [ABSTRACT FROM AUTHOR]

There is substantial interest in the role of ginger as an adjuvant therapy for chemotherapy-induced nausea and vomiting (CINV). However, available evidence lacks robust methodology. To assess the effect of adjuvant ginger compared with placebo on chemotherapy-induced nausea-related quality of life (QoL) and CINV-related outcomes. A parallel, double-blind, placebo-controlled randomized trial with 1:1 allocation was conducted. One hundred three chemotherapy-naïve adults scheduled to receive moderately to highly emetogenic chemotherapy at two hospitals in Australia were enrolled and analyzed. Four standardized ginger capsules (totaling 84 mg/day active gingerols/shogaols), or placebo, were administered commencing the day of chemotherapy and continuing for 5 days for chemotherapy cycles 1 through 3. The primary outcome was chemotherapy-induced nausea-related QoL. Secondary outcomes were vomiting- and CINV-related QoL; anticipatory, acute, and delayed nausea and vomiting; fatigue; nutritional status; depression and anxiety; health-related QoL; and adverse events. Intention-to-treat analysis was performed. Mixed analysis of variance with repeated measures determined differences between groups. The null hypothesis was no difference between groups. After applying a Bonferroni multiple testing correction, evidence against the null hypothesis was considered at P = 0.003. One hundred three participants (ginger: n = 52; placebo: n = 51) were enrolled and analyzed. There was clinically relevant evidence against the null hypothesis, favoring ginger, in change scores for nausea-related QoL (F [df] = 9.34[1,101]; P = 0.003; partial η2 = 0.09), overall CINV-related QoL (F [df] = 12.26[1,101]; P < 0.001; partial η2 = 0.11), delayed nausea severity (F [df] = 9.46[1,101]; P = 0.003; partial η2 = 0.09), and fatigue (F [df] = 10.11[1,101]; P = 0.002; partial η2 = 0.09). There was a clinically meaningful lower incidence of delayed nausea and vomiting in the ginger group at Cycle 2 (53% vs 75%; P = 0.020 and 4% vs 27%; P = 0.001, respectively) and Cycle 3 (49% vs 79%; P = 0.002 and 2% vs 23%; P = 0.001, respectively). There was a clinically meaningful lower incidence of malnutrition in the ginger group at Cycle 3 (18% vs. 41%; P = 0.032) and in change scores for Patient-Generated Subjective Global Assessment (F [df)] = 4.32[1,100]; P = 0.040; partial η2 = 0.04). Change scores between groups favored ginger for vomiting-related QoL and number of vomiting episodes; however, findings were not clinically meaningful. There was no effect of ginger on anticipatory or acute CINV, health-related QoL, anxiety, or depression. No serious adverse events were reported. Ginger supplementation was a safe adjuvant to antiemetic medications for CINV that enhanced QoL during chemotherapy treatment. Future trials are needed to examine dose-dependent responses to verify optimal dosing regimens. [ABSTRACT FROM AUTHOR]

Background: Gastroenteritis accounts for approximately 1.7 million visits to the emergency department (ED) by children in the United States every year. Data to determine whether the use of probiotics improves outcomes in these children are lacking.Methods: We conducted a randomized, double-blind trial involving 886 children 3 to 48 months of age with gastroenteritis who presented to six pediatric EDs in Canada. Participants received a 5-day course of a combination probiotic product containing Lactobacillus rhamnosus R0011 and L. helveticus R0052, at a dose of 4.0×109 colony-forming units twice daily or placebo. The primary outcome was moderate-to-severe gastroenteritis, which was defined according to a post-enrollment modified Vesikari scale symptom score of 9 or higher (scores range from 0 to 20, with higher scores indicating more severe disease). Secondary outcomes included the duration of diarrhea and vomiting, the percentage of children who had unscheduled physician visits, and the presence or absence of adverse events.Results: Moderate-to-severe gastroenteritis within 14 days after enrollment occurred in 108 of 414 participants (26.1%) who were assigned to probiotics and 102 of 413 participants (24.7%) who were assigned to placebo (odds ratio, 1.06; 95% confidence interval [CI], 0.77 to 1.46; P=0.72). After adjustment for trial site, age, detection of rotavirus in stool, and frequency of diarrhea and vomiting before enrollment, trial-group assignment did not predict moderate-to-severe gastroenteritis (odds ratio, 1.06; 95% CI, 0.76 to 1.49; P=0.74). There were no significant differences between the probiotic group and the placebo group in the median duration of diarrhea (52.5 hours [interquartile range, 18.3 to 95.8] and 55.5 hours [interquartile range, 20.2 to 102.3], respectively; P=0.31) or vomiting (17.7 hours [interquartile range, 0 to 58.6] and 18.7 hours [interquartile range, 0 to 51.6], P=0.18), the percentages of participants with unscheduled visits to a health care provider (30.2% and 26.6%; odds ratio, 1.19; 95% CI, 0.87 to 1.62; P=0.27), and the percentage of participants who reported an adverse event (34.8% and 38.7%; odds ratio, 0.83; 95% CI, 0.62 to 1.11; P=0.21).Conclusions: In children who presented to the emergency department with gastroenteritis, twice-daily administration of a combined L. rhamnosus-L. helveticus probiotic did not prevent the development of moderate-to-severe gastroenteritis within 14 days after enrollment. (Funded by the Canadian Institutes of Health Research and others; PROGUT ClinicalTrials.gov number, NCT01853124 .). [ABSTRACT FROM AUTHOR]

Background: Acute gastroenteritis develops in millions of children in the United States every year, and treatment with probiotics is common. However, data to support the use of probiotics in this population are limited.Methods: We conducted a prospective, randomized, double-blind trial involving children 3 months to 4 years of age with acute gastroenteritis who presented to one of 10 U.S. pediatric emergency departments. Participants received a 5-day course of Lactobacillus rhamnosus GG at a dose of 1×1010 colony-forming units twice daily or matching placebo. Follow-up surveys were conducted daily for 5 days and again 14 days after enrollment and 1 month after enrollment. The primary outcome was moderate-to-severe gastroenteritis, which was defined as an illness episode with a total score on the modified Vesikari scale of 9 or higher (scores range from 0 to 20, with higher scores indicating more severe disease), within 14 days after enrollment. Secondary outcomes included the duration and frequency of diarrhea and vomiting, the duration of day-care absenteeism, and the rate of household transmission (defined as the development of symptoms of gastroenteritis in previously asymptomatic household contacts).Results: Among the 971 participants, 943 (97.1%) completed the trial. The median age was 1.4 years (interquartile range, 0.9 to 2.3), and 513 participants (52.9%) were male. The modified Vesikari scale score for the 14-day period after enrollment was 9 or higher in 55 of 468 participants (11.8%) in the L. rhamnosus GG group and in 60 of 475 participants (12.6%) in the placebo group (relative risk, 0.96; 95% confidence interval, 0.68 to 1.35; P=0.83). There were no significant differences between the L. rhamnosus GG group and the placebo group in the duration of diarrhea (median, 49.7 hours in the L. rhamnosus GG group and 50.9 hours in the placebo group; P=0.26), duration of vomiting (median, 0 hours in both groups; P=0.17), or day-care absenteeism (median, 2 days in both groups; P=0.67) or in the rate of household transmission (10.6% and 14.1% in the two groups, respectively; P=0.16).Conclusions: Among preschool children with acute gastroenteritis, those who received a 5-day course of L. rhamnosus GG did not have better outcomes than those who received placebo. (Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT01773967 .). [ABSTRACT FROM AUTHOR]

Copyright of Jornal de Pediatria is the property of Sociedade Brasileira de Pediatria and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

This trial was performed to compare quince (Cydonia oblonga) fruit with vitamin B6 on 76 pregnant women with a gestational age of 6-14 weeks and mild-to-moderate nausea and vomiting (NVP) (40 in the quince and 36 in the B6 group). The 'Pregnancy-Unique Quantification of Emesis' (PUQE-24) scale was used to examine the severity of NVP. The quince syrup (1 tablespoon/TDS) or vitamin B6 tablets (20 mg/TDS) were used as intervention for 1 week. The mean (±SD) age was 27.5 (±5.2) years. The score of the PUQE was decreased from 9.5 (± 2) at baseline to 5.2 (±2.3) on the 7th day and 5.3 (±2.6) on the 14th day (p < .001) in the quince group. In the other group, the scores were 8.4 (±1.8), 7.3 (±2.4) and 7.7 (±3.8), respectively (p = .001). The change in symptoms were more marked in the quince group (p < .001). Quince syrup seems to be a suitable treatment for NVP. Impact statement What is already known on this subject: Pregnancy-induced nausea and vomiting (NVP) is one of the most common problems during gestation. Treatment is mainly symptomatic, ranging from dietary changes and oral pharmacological treatment to hospitalization in severe forms. In early pregnancy, the use of chemical drugs is avoided, so there is an increasing tendency to use alternative therapies. According to the literature review in Iranian Traditional Medicine (ITM), the quince fruit (Cydonia oblonga) can be useful in NVP. Quince has a wide range of pharmacological activities including antioxidant, antibacterial, antifungal, anti-inflammatory, hepatoprotective and antidepressant effects. ITM literature suggests some therapeutic effects of the quince fruit on important organs like brain, heart, liver and stomach. What the results of this study add: The results of this study demonstrated the significant efficacy of quince in comparison with vitamin B6. What the implications are of these findings for clinical practice and/or further research: This fruit is also safe to be administered in pregnant women suffering from NVP. [ABSTRACT FROM AUTHOR]

Study Objective To determine whether postoperative administration of low-dose intravenous naloxone decreases the incidence of postoperative nausea and vomiting ( PONV) and its impact on postoperative opioid requirements and pain scores. Design Meta-analysis of nine randomized controlled trials. Patients A total of 946 adult and pediatric patients who received low-dose intravenous naloxone for 24 hours after various surgeries. Measurements and Main Results Systemic literature searches of the Cochrane Central Register of Controlled Trials, Evidence-Based Medicine Reviews, PubMed, and Ovid MEDLINE databases were conducted. Among the relevant studies, data extraction and bias assessment determined the trials for inclusion in this meta-analysis. Nine randomized controlled trials met inclusion criteria. Naloxone demonstrated a reduced risk of postoperative nausea (risk ratio [ RR] 0.80, 95% confidence interval [ CI] 0.67-0.95, p=0.01) in a pooled analysis of eight of the nine studies. However, naloxone did not decrease the risk of postoperative vomiting in a collective assessment of all nine trials ( RR 0.83, 95% CI 0.63-1.09, p=0.18). Subgroup analysis of continuous-infusion naloxone found further reductions in nausea and vomiting, but these findings were limited to 186 of the 946 patients. Three studies recorded antiemetic doses and found an overall dose reduction ( RR 0.64, 95% CI 0.42-0.96, p=0.03). Compared with controls, naloxone prophylaxis of PONV did not significantly change cumulative postoperative opioid needs (mean difference 0.29 mg, 95% CI −3.55 to 4.13 mg, p=0.88) among five trials, nor visual analog scale pain scores (mean difference −0.11, 95% CI −0.26 to 0.05, p=0.18) in six studies. Conclusion This pooled analysis of data suggests that low-dose naloxone plays no role in preventing PONV, while exhibiting no significant effects on postoperative opioid needs and pain scores. The reduction demonstrated in postoperative nausea did not translate into decreases in postoperative vomiting. [ABSTRACT FROM AUTHOR]

Purpose: This study evaluated the efficacy and safety of a 3-day aprepitant regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) during the first cycle of non-anthracycline plus cyclophosphamide (AC)-based moderately emetogenic chemotherapy (MEC) based on government guidelines in Korean patients.Methods: This multicenter, randomized, double-blind, phase IV trial (NCT01636947) enrolled adult South Korean patients with a broad range of tumor types who were scheduled to receive a single dose of ≥1 MEC agent. Patients were randomized to a 3-day regimen of aprepitant (aprepitant regimen) or placebo (control regimen) on top of ondansetron plus dexamethasone. The primary and key secondary efficacy endpoints were the proportions of subjects who achieved no vomiting and complete response (CR) during the overall phase.Results: Of the 494 randomized subjects, 480 were included in the modified intent-to-treat population. Response rates for no vomiting and CR in the overall phase were numerically higher for the aprepitant regimen compared with the control regimen groups, but failed to reach statistical significance (no vomiting 77.2 vs 72.0%; p = 0.191; CR 73.4 vs 70.4%; p = 0.458). Both the aprepitant and control regimens were generally well tolerated.Conclusion: A 3-day aprepitant regimen was numerically better but not statistically superior to a control regimen with respect to the achievement of no vomiting or CR during the overall phase in a non-AC MEC Korean population based on government reimbursement guidelines.Trial Registration: ClinicalTrials.gov NCT01636947 ( https://clinicaltrials.Gov/ct2/show/NCT01636947 ). [ABSTRACT FROM AUTHOR]

Purpose: Even with the use of modern antiemetic drugs, chemotherapy-induced nausea and vomiting (CINV) is still a cause of great distress to the patients. Olanzapine, primarily marketed as an antipsychotic, was found to reduce nausea and vomiting in some chemotherapy patients. But it was never tested in Indian population with a diverse genetic background. The present study aims to evaluate the role of olanzapine in CINV in patients receiving platinum-based chemotherapy.Methods: The study was a randomized, controlled, assessor-blinded study on 100 chemotherapy-naïve consenting patients receiving any one from cisplatin, carboplatin or oxaliplatin. The control group (n = 50) received palonosetron and dexamethasone in the approved therapeutic dose from the day 1 of chemotherapy. The test group (n = 50) received additional olanzapine 10 mg/day from day 1 for five consecutive days. CINV and quality of life (QoL) were assessed.Results: Vomiting was significantly less among the olanzapine-treated patients. Control of delayed emesis was significantly better in this group (complete response among 96 vs. 42 % in the control group, p value <0.0001). Incidence and severity of nausea was significantly less in this group. Failure of anti-CINV measure was 4 % in this group compared to 26 % of the patients of the control group during overall days 1-5. Though sedation was more in these olanzapine-treated patients, there was no dose-limiting adverse event. Quality of life was also better among the olanzapine-treated patients.Conclusion: Olanzapine was found to be effective as add-on in the control of CINV. [ABSTRACT FROM AUTHOR]

Objective: To assess the comparative cost effectiveness of day care over inpatient management of nausea and vomiting of pregnancy (NVP).Study Design: A cost utility analysis was performed using a decision analytical model in which a Markov model was constructed. The Markov model was primarily populated with data from a recently published randomised controlled trial. Which included pregnant women presenting to Cork University Maternity Hospital, a tertiary referral maternity hospital, seeking treatment for NVP. Costs and outcomes were estimated from the perspective of the Irish health service (HSE) and patients. A probabilistic sensitivity analysis, using a Monte Carlo simulation, was also performed. A Bayesian Value of Information analysis was used to estimate the value of collecting additional information.Results: When both the healthcare provider and patient's perspective was considered, day care management of NVP remained less costly (mean €985; 95% C.I. 705-1456 vs. €3837 (2124-8466)) and more effective (9.42; 4.19-12.25 vs. 9.49; 4.32-12.39 quality adjusted life years) compared with inpatient management. The Cost Effectiveness Acceptability Curve indicates the probability that day care management is 70% more cost effective compared to inpatient management at a ceiling ratio of €45,000 per QALY, indicating little decision uncertainty. The Bayesian Value of Information analysis indicates there is value in collecting further information; the Expected Value of Perfect Information (EVPI) is estimated to be €5.4 million.Conclusion: Day care management of NVP is cost effective compared to inpatient management. [ABSTRACT FROM AUTHOR]

Background: To establish the role of antiemetic therapy with neurokinin-1 (NK1) receptor antagonists (RAs) in nonan-thracycline and cyclophosphamide (AC)-based moderately emetogenic chemotherapy (MEC) regimens, this study evaluated single-dose intravenous (i.v.) fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) associated with non-AC MEC. Patients and methods: In this international, phase III, double-blind trial, adult cancer subjects scheduled to receive >1 non-AC MEC on day 1 were randomized to a regimen comprising single-dose i.v. fosaprepitant 150 mg or placebo along with ondansetron and dexamethasone on day 1; control regimen recipients received ondansetron on days 2 and 3. Primary end points were the proportion of subjects achieving a complete response (CR; no vomiting and no use of rescue medication) in the delayed phase (25-120 h after MEC initiation) and safety. Secondary end points included CR in the overall and acute phases (0-120 and 0-24 h after MEC initiation, respectively) and no vomiting in the overall phase. Nausea and the Functional Living Index-Emesis were assessed as exploratory end points. Results: The fosaprepitant regimen improved CR significantly in the delayed (78.9% versus 68.5%; P<0.001) and overall (77.1% versus 66.9%; P<0.001) phases, but not in the acute phase (93.2% versus 91.0%; P = 0.184), versus control. In the overall phase, the proportion of subjects with no vomiting (82.7% versus 72.9%; P< 0.001) and no significant nausea (83.2% versus 77.9%; P = 0.030) was also significantly improved with the fosaprepitant regimen. The fosaprepitant regimen was generally well tolerated. Conclusion: Single-dose fosaprepitant added to a 5-HT3 RA and dexamethasone was well tolerated and demonstrated superior control of CINV (primary end point achieved) associated with non-AC MEC. This is the first study to evaluate NK1 RA therapy as an i.v. formulation in a well-defined non-AC MEC population. ClinicalTrials.gov: NCT01594749 (https://clinicaltrials.gov/ct2/show/NCT01594749). [ABSTRACT FROM AUTHOR]

Study Question: Does adding psychological intervention to medical therapy improve nausea/vomiting, psychological symptoms, and pregnancy distress in women with moderate nausea and vomiting of pregnancy (NVP)?Summary Answer: Three weeks of medical therapy plus psychotherapy yielded statistically and clinically significant improvements in NVP-specific symptoms, anxiety/depression symptoms, and pregnancy distress, compared with medical therapy alone.What Is Known Already: Pregnancy with nausea/vomiting is associated with psychiatric morbidity. Evidence supports the exploration of psychosocial reactions in addition to biochemical markers related to NVP.Study Design, Size, Duration: This prospective, open-label, randomized, controlled, parallel-group study was performed at two obstetrics clinics in Iran. A total of 86 women, aged 18-40 years, between 6 and 12 weeks pregnant with moderate NVP, more than 5 years of education, and not currently practicing any relaxation techniques or undergoing any psychotherapy, were enrolled from June 2013 to November 2014.Participants/materials, Setting, Methods: A total of 86 moderate NVP women were randomly allocated to either a control (medical therapy alone) or experimental (medical therapy plus psychotherapy) group. Block randomization was achieved using a paper list prepared by an investigator with no clinical involvement in the trial. The experimental group was given pyridoxine hydrochloride (40 mg daily) for 3 weeks, and also received intensive mindfulness-based cognitive therapy (MBCT) in eight individual sessions (50 min each) over 3 weeks. The control group was given pyridoxine hydrochloride (40 mg daily tablet) for 3 weeks alone. All participants completed the Rhodes index of nausea, vomiting and retching (RINVR), the hospital anxiety and depression scale (HADS), and the prenatal distress questionnaire (PDQ) at baseline, 3 weeks after baseline at the end of the study, and at a 1 month post-treatment follow-up. Linear mixed-effects models were used, in an intention-to-treat analysis.Main Results and Role Of Chance: In the psychotherapy plus medical therapy group, the mean relative difference between baseline and post-treatment decreased for RINVR; nausea 8.2 (95% confidence interval (CI) 4.1, 10.2), vomiting 3.5 (95% CI 1.5, 5.8), and total RINVR 11.7 (95% CI 6.5, 16.5), for HADS; anxiety 5.1 (95% CI 3.2, 9.2), depression 3.5 (95% CI 2.4, 7.3), total HADS 7.2 (95% CI 4.4, 12.1), for PDQ; birth concerns 3.3 (95% CI 1.3, 9.1), body concerns 1.5 (95% CI 0.9, 5.1), relationship concerns 2.1 (95% CI 1.2, 5.9), and total PDQ 5.9 (95% CI 3.5, 10.6). At 1 month after treatment, the statistically significant improvement in RINVR, HADS and PDQ, as well as clinical improvement in severity of symptoms, persisted. Medical therapy plus psychotherapy also improved nausea/vomiting symptoms, psychological symptoms, and reduced pregnancy distress more than medical therapy alone, with an effect size of 0.42-0.72 over the trial period.Limitations, Reasons For Caution: The conclusions were limited to a small number of women with moderate NVP. It is unclear whether the difference between the outcomes in the different groups was related to MBCT alone, or to the extra time and attention paid to patients in the medical therapy plus psychotherapy. The participants in the study did not remain blind to the treatment and the outcome may only be representative of women with moderate NVP who have been referred to obstetrics clinics.Wider Implications Of the Findings: These findings show that adding 3 weeks of psychological intervention to medical therapy may appear to produce positive therapeutic outcomes upon conclusion of treatment, and 1 month after treatment. This suggests that psychotherapy should be considered as an adjunctive treatment option for women with moderate NVP. In future studies, however, a group of patients who are receiving placebo psychotherapy along with medical treatment should be included. Furthermore, an economic evaluation of the addition of psychological intervention to standard medical therapy would be useful. [ABSTRACT FROM AUTHOR]

Purpose: The study was designed to assess the efficacy of palonosetron and ramosetron in preventing postoperative nausea and vomiting (PONV) related to intravenous (IV) patient-controlled analgesia (PCA) with opioids after gynecological laparoscopic surgery. Methods: Patients were randomly allocated to 4 groups-C, P, R0.3 and R. At the end of surgery, group C received an infusion of 50 ml normal saline, group P received palonosetron 75 μg mixed in 50 ml normal saline, and groups R0.3 and R received ramosetron 0.3 mg mixed in 50 ml normal saline. A PCA pump containing fentanyl was connected for all groups; however, ramosetron 0.6 mg was mixed with the PCA regimen for the R group. PONV and postoperative pain were assessed. Results: PONV incidence and scale, and Rhodes index in R group between 24 and 72 h after discharge from the post-anesthetic care unit (PACU) showed significantly lower values, compared with the other groups. PONV incidence and scale, and Rhodes index in P group and R0.3 group were lower than the corresponding values in C group at all times, without statistical significance. Conclusion: A single dose of palonosetron 75 μg or ramosetron 0.3 mg was unable to prevent PONV related to IV PCA with opioids in patients undergoing gynecological laparoscopic surgery. The combination of a single dose of ramosetron 0.3 mg, followed by ramosetron 0.6 mg mixed with PCA, significantly decreased PONV compared with a single dose of palonosetron 75 μg or ramosetron 0.3 mg. [ABSTRACT FROM AUTHOR]

Purpose: Newer drugs incorporated in prophylactic regimens for chemotherapy-induced nausea and vomiting (CINV) have resulted in significantly reduced rates of this feared complication of cytotoxic chemotherapy. However, both delayed chemotherapy-induced nausea and breakthrough CINV remain difficult areas of management and require novel treatment strategies. Recent randomized trial evidence has suggested that olanzapine, an atypical antipsychotic, may have a role in both the prevention and treatment of CINV. A systematic review was conducted to assess the efficacy of olanzapine in (a) preventing CINV in highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC) and (b) the treatment of breakthrough CINV. The toxicity of olanzapine in this setting was also reviewed. Methods: MEDLINE, Embase and Cochrane Database of Systematic Reviews databases were searched to identify all randomized clinical trials (RCTs) investigating olanzapine in patients receiving chemotherapy. Results: A total of 488 patients from three trials of CINV prophylaxis and 323 patients from three trials of breakthrough CINV were included. Regimens including olanzapine were associated with significant improvements in CINV prevention with both HEC and MEC. Single agent olanzapine for breakthrough nausea was superior to standard alternative options. Conclusion: Data from RCTs support the use of an olanzapine containing combination regimen as an option for CINV prophylaxis and single agent olanzapine for the treatment of breakthrough CINV. In the included trials, the short duration of olanzapine appears safe and well tolerated. [ABSTRACT FROM AUTHOR]

Background: Vomiting is one of the most prevalent side effects of chemotherapy in cancer patients. The aim of this study was to evaluate the effect of ginger plant on chemotherapy-induced vomiting, since the previous studies were somehow imperfect and have provided controversial results. Materials and Methods: This randomized double-blind placebo-controlled clinical trial was conducted on 80 women with breast cancer undergoing chemotherapy and suffering from vomiting in Imam Khomeini Hospital, Tehran, Iran, between July and December 2009. During a convenience sampling the participants were randomly allocated into treatment and placebo groups after taking a written informed consent. Two groups were matched based on the age and emetic risk of chemotherapy drugs. The treatment group received 250 mg ginger powder capsules (Zintoma) and placebo group 250 mg starch capsules 4 times a day (1 g/day) for 6 days since 3 days before chemotherapy session. A two-part self-made questionnaire was used to assess the effect of ginger. Patients completed the instrument every day. Then by STATA software version 8, the gathered data were analyzed using Fisher's exact, Kruskal-Wallis, and Chi-square tests. Results: The 2 groups had no significant age differences and were matched (ginger: 41.8±8.4 vs placebo: 45.1±10, P = 0.1). Vomiting cases were significantly lower in ginger group at anticipatory (P = 0.04), acute (P = 0.04), and delayed (P = 0.003) phases. Also, heartburn was the only and venial reported side effect (P > 0.05). Conclusions: Taking ginger capsules (for 6 days since 3 days before chemotherapy) accompanied by the routine antiemetic treatment could relieve chemotherapy-induced vomiting in all phases. [ABSTRACT FROM AUTHOR]

Purpose: To systematically review the effectiveness and safety of 5-hydroxytryptamine-3 receptor antagonists (5-HT3 RAs) compared with other antiemetic medication or placebo for prophylaxis of radiation-induced nausea and vomiting. Methods and Materials: We searched the following electronic databases: MEDLINE, Embase, the Cochrane Central Register of Controlled Clinical Trials, and Web of Science. We also hand-searched reference lists of included studies. Randomized, controlled trials that compared a 5-HT3 RA with another antiemetic medication or placebo for preventing radiation-induced nausea and vomiting were included. We excluded studies recruiting patients receiving concomitant chemotherapy. When appropriate, meta-analysis was conducted using Review Manager (v5) software. Relative risks were calculated using inverse variance as the statistical method under a random-effects model. We assessed the quality of evidence by outcome using the Grading of Recommendations Assessment, Development, and Evaluation approach. Results: Eligibility screening of 47 articles resulted in 9 included in the review. The overall methodologic quality was moderate. Meta-analysis of 5-HT3 RAs vs. placebo showed significant benefit for 5-HT3 RAs (relative risk [RR] 0.70; 95% confidence interval [CI] 0.57–0.86 for emesis; RR 0.84, 95% CI 0.73–0.96 for nausea). Meta-analysis comparing 5-HT3 RAs vs. metoclopramide showed a significant benefit of the 5-HT3 RAs for emetic control (RR 0.27, 95% CI 0.15–0.47). Conclusion: 5-Hydroxytryptamine-3 RAs are superior to placebo and other antiemetics for prevention of emesis, but little benefit was identified for nausea prevention. 5-Hydroxytryptamine-3 RAs are suggested for prevention of emesis. Limited evidence was found regarding delayed emesis, adverse events, quality of life, or need for rescue medication. Future randomized, controlled trials should evaluate different 5-HT3 antiemetics and new agents with novel mechanisms of action such at the NK1 receptor antagonists to determine the most effective drug. Delayed nausea and vomiting should be a focus of future study, perhaps concentrating on the palliative cancer population. [ABSTRACT FROM AUTHOR]

Objectives: To examine the effect of acupuncture and the relaxation response (RR) for treating gastrointestinal (GI) symptoms in HIV patients who are using highly active antiretroviral therapy (HAART). Methods: The authors conducted a 4-arm 2Ã2 double-blind randomised controlled trial in an acupuncture clinic in the USA. Sham acupuncture and health education were used as the control conditions of real acupuncture and RR elicitation, respectively. Enrolled patients were randomised to real acupuncture+RR (AR), sham acupuncture+RR (SR), real acupuncture+health education (AE) or sham acupuncture+health education (SE) study arm. Participants listened to CDs with RR-eliciting instructions or health education while receiving acupuncture intervention. Interventions were provided twice weekly for 4 weeks and once weekly for another 4 weeks. Participants used daily diaries to record GI symptom severity ratings (0--10). The authors estimated the intervention effect as the changes in symptom rating per intervention session increase using a mixed-effects regression model. Results: A total of 130 people with HIV/AIDS who were on HAART and had persistent GI symptoms were enrolled and 115 started the study intervention. The AR group had greater intervention effects for loose stools symptoms than the other three groups (β= --0.149, --0.151 and --0.144, p value=0.013, 0.013 and 0.018 comparing AR to AE, SR and SE, respectively). The AR group also had significant intervention effects on reducing nausea symptoms when the intervention was given twice per week (β=--0.218, p=0.001). Conclusions Our trial provided preliminary data demonstrating the potential synergistic effects of acupuncture and RR for treating GI symptoms in HIV patients on HAART. [ABSTRACT FROM AUTHOR]

Background Many acupuncture studies are of weak methodological quality, possibly due to lack of pilot testing. This pilot study tested design features, including test of feasibility, compliance to treatment and data collection, level of blinding success and the patients' potential perceived effects of the treatment, in preparation for an efficacy study. Method A modified single subject experimental design was conducted. 10 cancer patients were randomised to verum penetrating acupuncture or non-penetrating sham needles for 30 min 2-3 times/week during radiotherapy over abdomen/pelvis. They answered test-retested emesis questions (r=0.527-1.0) covering nausea, vomiting, use of antiemetics, wellbeing and activities of daily living. Results Overall, the patients completed 98% of the 345 emesis-questionnaire days and 101 of the 115 offered treatments. All patients believed they received verum acupuncture. 10 patients experienced antiemetic effects, seven relaxation,five pain-reduction and five experienced sleep improvement. Two types of nausea questions showed absolute concordance (r=1.0) (n of observations=456). Nausea was experienced by one of five verum acupuncture treated patients (duration median 0% of the radiotherapy-days) and four of five sham acupuncture treated patients (duration median 24% of the radiotherapy-days). Patients experiencing nausea rated decreased wellbeing and performance of daily activities compared to patients free from nausea. Conclusions All patients were blinded, complied with verum/sham treatments and data-collection, and believed they had effects of the received treatment. The methods for verum/sham treatment and data collection may thus be used in an adequately powered randomised controlled study of the effect of acupuncture for radiotherapy-induced emesis. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effectiveness of acupuncture and acupressure as supplements to standard treatment for postoperative vomiting in children undergoing tonsillectomy and/or adenoidectomy. Methods: A pragmatic, open, block-randomised controlled trial. The results were analysed according to the intention-to-treat principle. The study was conducted without extra resources in a normal setting at the day-surgery department of Lovisenberg Diakonale Hospital in Oslo. 154 children with an American Society of Anesthesiologists grade 1-2, weighing at least 10 kg, were included. Children with concomitant gastrointestinal diseases, emesis or antiemetic treatment <24 h preoperatively, rash or local infection over the actual acupuncture points were excluded together with patients whose parents' informed consent could not be obtained. The intervention group received acupuncture at pericardium 6 bilaterally, at a depth of approximately 0.7 cm with a median of 21 min during anaesthesia, followed by acupressure wristbands for 24 h and standard treatment. The control group received standard treatment. The primary end point was the occurrence of vomiting or retching during 24 h postoperatively. Results: Children in the acustimulation group experienced less retching and vomiting than the control group--46.8% versus 66.2% (p=0.015). The effect of acustimulation was specifically pronounced in girls and children aged 1-3 years. Conclusion: This trial indicates the effectiveness of acustimulation as an adjunct to standard treatment. The results should encourage and promote the implementation of acustimulation for postoperative vomiting in children undergoing adenoidectomy or tonsillectomy. [ABSTRACT FROM AUTHOR]

Background: Postoperative nausea and vomiting (PONV) are distressing and frequent adverse effects (AEs) in women undergoing laparoscopic gynecologic surgery. Midazolam has been reported to be effective for preventing PONV in adults undergoing middle ear surgery and children undergoing strabismus surgery or tonsillectomy. Objective: The aim of this study was to assess the antiemetic effects of midazolam on PONV in women undergoing laparoscopic gynecologic surgery. Methods: This prospective, randomized, double-blind, placebo-controlled study was conducted (January–December 2009) at the Department of Anesthesiology, Ushiku Aiwa General Hospital (Ibaraki, Japan). Nonpregnant Japanese women (aged 22–54 years) undergoing myomectomy, hysterectomy, salpingo-oophorectomy, or oophorectomy were randomized to receive 1 of 2 different midazolam doses (50 or 75 μg/kg IV) or placebo immediately after induction of anesthesia. Anesthesia was induced with propofol 2 mg/kg IV, and vecuronium 0.1 mg/kg IV was used to facilitate tracheal intubation. After tracheal intubation, anesthesia was maintained with sevoflurane 1.0% to 3.0% (inspired concentration) and air in oxygen. All episodes of PONV during the first 24 hours after anesthesia were assessed by an investigator 24 hours postoperatively; the investigator was blinded as to which treatment each patient had received. The patients were asked if nausea, vomiting, or retching had occurred. Details were recorded of any other AEs, as well as any spontaneous complaints. Results: A total of 90 nonpregnant Japanese women were enrolled (mean [SD] age, 35 [6] years; mean height, 159 [6] cm; mean weight, 53 [8] kg). Each study group comprised 30 patients and was comparable with regard to patient demographic characteristics and types of surgery. The rate of patients experiencing PONV during the first 24 hours after anesthesia with midazolam 50 μg/kg was 30% (P = 0.004 vs placebo) compared with 27% with midazolam 75 μg/kg (P = 0.002 vs placebo) and 67% with placebo. The difference in the incidence of PONV between patients receiving midazolam 75 μg/kg and those receiving midazolam 50 μg/kg was not statistically significant. No clinically important AEs due to the study drug were observed in any of the groups. Conclusion: Midazolam 50 μg/kg was not significantly different from midazolam 75 μg/kg in the incidence of PONV, and both doses were associated with significantly less PONV compared with placebo during the first 24 hours after anesthesia in these Japanese women undergoing laparoscopic gynecologic surgery. [Copyright &y& Elsevier]

Background and Objective: Recently, dexamethasone has been found to have a prophylactic effect on postoperative vomiting and pain in children undergoing tonsillectomy. However, few studies have examined the preemptive analgesic effects of dexamethasone after tonsillectomy. The aim of this study was to evaluate the effect of pre-incisional infiltration of tonsils with dexamethasone on the incidence and severity of postoperative pain and vomiting in children undergoing tonsillectomy under general anesthesia. Materials and Methods: In a double blinded study, 62 patients were randomly allocated to infiltrate dexamethasone (0.5 mg/kg, maximum dose, 12 mg) or an equivalent volume of saline at the peritonsillar region. All infiltrations were performed following the induction of general anesthesia and 5 minutes prior to the onset of surgery. Anesthetic agents, end-tidal carbon dioxide levels, and the administration of intravenous fluids were carefully regulated. Surgery was performed by one attending otolaryngologists using the same dissection and snare technique. The incidence of pain and vomiting, need for rescue antiemetics, and analgesic consumption were compared in both groups. Pain scores used included Children's Hospital Eastern Ontario Pain Scale, "faces", and a 0-10 visual analogue pain scale. Results: Demographics of dexamethasone and placebo groups were similar. No statistically significant difference was found between the dexamethasone and placebo groups in pain score, nausea, vomiting, irritability, or analgesic requirement postoperatively. Conclusion: Preincisional infiltration of the tonsils with dexamethasone play a limited role in the recovery phase from tonsillectomy, but further prospective, randomized studies are needed to support it. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the efficacy and safety of oral ondansetron (Zofran) as an antiemetic in patients receiving cyclophosphamide-based chemotherapy.Design: A multicenter, randomized, double-blind, stratified, placebo-controlled trial conducted between March 1989 and January 1990.Setting: Twenty-seven oncology centers including university hospitals, community cancer centers, and private medical oncology practices.Patients: A total of 349 chemotherapy-naive patients having their first cycle of cyclophosphamide (> or = 450 mg/m2)-based chemotherapy. Patients also received methotrexate (> or = 30 mg/m2) or doxorubicin (> or = 35 mg/m2). All patients were evaluated for safety and 318 (91%) were evaluated for efficacy.Interventions: Patients were randomly assigned to one of four treatment groups: placebo, 1 mg, 4 mg, or 8 mg of ondansetron. Assigned study medication was taken three times per day for 3 consecutive days.Measurements: Time and number of emetic episodes as well as degree of nausea were recorded by patients for each of the 3 study days.Results: Compared with placebo, all three doses of ondansetron were superior (P < 0.001) in preventing vomiting and controlling nausea. A complete response (no emetic episodes) was observed in 19%, 57%, 65%, and 66% of patients in the placebo, 1-mg, 4-mg, and 8-mg ondansetron groups, respectively. For patients who received higher-dose cyclophosphamide and doxorubicin, a dose-related trend in antiemetic efficacy of ondansetron was observed. Mild headache and constipation were the most frequently reported adverse events. No extrapyramidal reactions were observed.Conclusion: Oral ondansetron is a safe and effective antiemetic that is more efficacious than placebo for patients receiving cyclophosphamide-based chemotherapy. [ABSTRACT FROM AUTHOR]