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Background Emergence agitation and delirium in children remain a common clinical challenge in the post-anesthetic care unit. Preoperative oral melatonin has been suggested as an effective preventive drug with a favorable safety profile. The oral bioavailability of melatonin, however, is low. Therefore, the MELA-PAED trial aims to investigate the efficacy and safety of intraoperative intravenous melatonin for the prevention of emergence agitation in pediatric surgical patients. Methods MELA-PAED is a randomized, double-blind, parallel two-arm, multi-center, superiority trial comparing intravenous melatonin with placebo. Four hundred participants aged 1–6 years will be randomized 1:1 to either the intervention or placebo. The intervention consists of intravenous melatonin 0.15 mg/kg administered approximately 30 min before the end of surgery. Participants will be monitored in the post-anesthetic care unit (PACU), and the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) will be performed on days 1, 7, and 14 after the intervention. Serious Adverse Events (SAE) will be assessed up to 30 days after the intervention. Results The primary outcome is the incidence of emergence agitation, assessed dichotomously as any Watcha score >2 during the participant's stay in the post-anesthetic care unit. Secondary outcomes are opioid consumption in the post-anesthetic care unit and adverse events. Exploratory outcomes include SAEs, postoperative pain, postoperative nausea and vomiting, and time to awakening, to first oral intake, and to discharge readiness. Conclusion The MELA-PAED trial investigates the efficacy of intravenous intraoperative melatonin for the prevention of emergence agitation in pediatric surgical patients. Results may provide further knowledge concerning the use of melatonin in pediatric perioperative care., Background: Emergence agitation and delirium in children remain a common clinical challenge in the post-anesthetic care unit. Preoperative oral melatonin has been suggested as an effective preventive drug with a favorable safety profile. The oral bioavailability of melatonin, however, is low. Therefore, the MELA-PAED trial aims to investigate the efficacy and safety of intraoperative intravenous melatonin for the prevention of emergence agitation in pediatric surgical patients. Methods: MELA-PAED is a randomized, double-blind, parallel two-arm, multi-center, superiority trial comparing intravenous melatonin with placebo. Four hundred participants aged 1–6 years will be randomized 1:1 to either the intervention or placebo. The intervention consists of intravenous melatonin 0.15 mg/kg administered approximately 30 min before the end of surgery. Participants will be monitored in the post-anesthetic care unit (PACU), and the Post Hospitalization Behavior Questionnaire for Ambulatory Surgery (PHBQ-AS) will be performed on days 1, 7, and 14 after the intervention. Serious Adverse Events (SAE) will be assessed up to 30 days after the intervention. Results: The primary outcome is the incidence of emergence agitation, assessed dichotomously as any Watcha score >2 during the participant's stay in the post-anesthetic care unit. Secondary outcomes are opioid consumption in the post-anesthetic care unit and adverse events. Exploratory outcomes include SAEs, postoperative pain, postoperative nausea and vomiting, and time to awakening, to first oral intake, and to discharge readiness. Conclusion: The MELA-PAED trial investigates the efficacy of intravenous intraoperative melatonin for the prevention of emergence agitation in pediatric surgical patients. Results may provide further knowledge concerning the use of melatonin in pediatric perioperative care.

Background: The international advanced trauma life support guidelines recommend that all severely injured trauma patients receive supplemental oxygen based on very limited evidence. The TRAUMOX2 trial randomises adult trauma patients to a restrictive or liberal oxygen strategy for 8 h. The primary composite outcome consists of 30-day mortality and/or development of major respiratory complications (pneumonia and/or acute respiratory distress syndrome). This manuscript presents the statistical analysis plan for TRAUMOX2. Methods: Patients are randomised 1:1 in variable block sizes of four, six and eight, stratified by including centre (pre-hospital base or trauma centre) and tracheal intubation at inclusion. The trial will include 1420 patients to be able to detect a 33% relative risk reduction with the restrictive oxygen strategy of the composite primary outcome with 80% power at the 5% significance level. We will conduct modified intention-to-treat analyses on all randomised patients and per-protocol analyses for the primary composite outcome and key secondary outcomes. The primary composite outcome and two key secondary outcomes will be compared between the two allocated groups using logistic regression reported as odds ratios with 95% confidence intervals adjusted for the stratification variables as in the primary analysis. A p-value below 5% will be considered statistically significant. A Data Monitoring and Safety Committee has been established to conduct interim analyses after inclusion of 25% and 50% of the patients. Conclusion: This statistical analysis plan of the TRAUMOX2 trial will minimise bias and add transparency to the statistics applied in the analysis of the trial. The results will add evidence on restrictive and liberal supplemental oxygen strategies for trauma patients. Trial Registration: EudraCT number: 2021–000556-19; ClinicalTrials.gov identifier: NCT05146700 (date of registration: 7 December 2021).

The incidence of chemical burns appears to be increasing. Diphoterine is an amphoteric, chelating, polyvalent solution used for the decontamination of chemical splashes. In this systematic review, we aimed to assess the effect of diphoterine on chemical burns compared with water or no treatment. The primary endpoint was the depth of burn, and secondary outcomes included pain, duration of hospitalization, time to return to work, need for surgery, pH, and complications. PubMed, Embase, Cochrane Library, Web of Science, and Google Scholar were systematically searched using the terms “Diphoterine”, “Previn”, and ““Amphoteric solution” AND “burn””. A total of nine studies were included. One study evaluated the depth of chemical burns and found no difference between the diphoterine group and the control group. Four studies reported on pain, three of which found a more pronounced decrease in pain when using diphoterine compared to the control groups. Two studies found a significant neutralization of pH when using diphoterine. No differences were found for the remaining endpoints. Based on the very low certainty of evidence, this systematic review reports no observed difference between diphoterine and water or no treatment on the depth of a chemical burn. Diphoterine appeared to be associated with less pain and to have a neutralizing effect.

Emergent brain computed tomography (CT) scan allows for identification of patients presenting with acute severe neurological symptoms in whom medical and surgical interventions may be lifesaving. The aim of this study was to evaluate if time to CT from arrival at the emergency department exceeded 30 min in patients admitted with acute severe neurological symptoms. This was a retrospective register-based quality assurance study. We identified patients admitted to the emergency department with acute severe neurological symptoms between April 1st, 2016 and September 30th, 2020. Data were retrieved from the registry of acute medical team activations. We considered that time to CT from arrival at the emergency department should not exceed 30 min in more than 10% of patients. A total of 559 patients were included. Median time from arrival at the emergency department until CT scan was 24 min (IQR 16–35) in children (< 18 years), 10 min (IQR 7–17) for adults (18–59 years), and 11 min (IQR 7–16) for elders (> 60 years). This time interval exceeded 30 min for 8.2% (95% CI 6.1–10.9) of all included patients, 35.3% of children, 5.9% of adults, and 8.6% of elders. No children died within 30 days. The 30-day mortality was 21.3% (95% CI 16.4–27) in adults, and 43.9% (95% CI 38.2–49.8) in elders. Time from arrival at our emergency department until brain CT scan exceeded 30 min in 8.2% of all included patients but exceeded the defined quality aim in children and could be improved.

Background The clinical benefit of Early Warning Scores (EWSs) is undocumented. Nursing staff's clinical assessment might improve the prediction of outcome and allow more efficient use of resources. We aimed to investigate whether the combination of clinical assessment and EWS would reduce the number of routine measurements without increasing mortality.Methods We did a cluster-randomised, crossover, non-inferiority study at eight hospitals in Denmark. Patients aged 18 years or older, admitted for more than 24 h were included. Admissions to paediatric or obstetric wards were excluded. The participating hospitals were randomly assigned 1:1 to start as either intervention or control with subsequent crossover. Primary outcomes were 30-day all-cause mortality (non-inferiority margin=0. 5%) and average number of EWS per day per patient. The intervention was implementation of the Individual EWS (I-EWS), in which nursing staff can adjust the calculated score on the basis of their dinical assessment of the patient. I-EWS was compared with the National Early Warning Score (NEWS). The study is registered at ClinicalTrials.gov, NCT03690128 and is complete.Findings Unique admissions longer than 24 h were included from Oct 15, 2018 to Sept 30, 2019. Of 90 964 patients assessed, n=46 470 were assigned to the I-EWS group and n=14494 to the NEWS group. Mortality within 30 days was 4. 6% for the I-EWS group, and 4.3% for the NEWS group (adjusted odds ratio 1.05 [95% CI 0.99-1.12], p=0.12). In subgroup analyses I-EWS showed increased 30-day mortality for hospitals that did I-EWS in fall-winter, which was probably due to seasonality, and within patients admitted in a surgical specialty. Overall risk difference was 0.22% (95% CI -0.04 to 0.48) meaning that the non-inferiority criteria were met. The average number of scorings per patient per day was reduced from 3.14 to 3.10 (ie, a relative reduction of 0.64% [95% CI -0.16 to -1.11], p=0.0084) in the I-EWS group.I

Introduction: Timely admission to a facility capable of providing highly specialised treatment is key in patients with spontaneous subarachnoid haemorrhage. We aimed to determine the time elapsed from the initial emergency telephone call to arrival at a neurosurgical department. Also, we aimed to determine the ambulance dispatch criteria used and the activated prehospital responses. Methods: This was a retrospective study. Patients admitted in the Capital Region of Denmark within a 3.5-year period were identified in the Danish National Patient Register. Data were extracted from medical records and from automated telephone logs at the Emergency Medical Dispatch Centre. Results: Time intervals were available in 124 out of 262 patients and ambulance dispatch criteria in 98 patients. The median time from call to neurosurgical admission was 207.5 minutes. The dispatch criterion sudden severe headache had a sensitivity of 17.4%. An ambulance with lights and sirens was dispatched to 77% of patients and 28% were brought directly to a hospital with neurosurgical facilities. Conclusions: The median time from emergency call to neurosurgical admission was 3.5 hours. No single dispatch criterion detected the condition with an acceptable sensitivity. A high proportion of patients received an ambulance with lights and sirens, but more than two out of three were not initially brought to a hospital with neurosurgical facilities. Funding: the non-profit organisation Trygfonden Trial registration: NCT03786068 (www.clinicaltrials.gov)

Burn surgery can cause extensive bleeding, which lead to perioperative blood transfusions. The purpose of this study was to investigate whether blood transfusions during burn surgery, guided by standard monitoring with inspection of the operative field, measurements of blood pressure, heart rate, hourly diuresis, and concentrations of hemoglobin and lactate could sustain the preoperative cardiac output (CO) till end of surgery. We investigated 15 patients ≥18 years of age scheduled for burn surgery, where the perioperative monitoring included an arterial line. After induction of anesthesia and before start of surgery, we measured baseline values of CO with the minimally invasive LiDCOrapid, mean arterial pressure, and concentrations of hemoglobin and lactate in arterial blood. We measured these values every 30 minutes through surgery. The primary outcome was change in CO from baseline till end of surgery. Secondary outcomes included the change in concentrations of hemoglobin and lactate from baseline till end of surgery. We found no statistically significant change in CO from baseline till end of surgery (6.6 [±2.4] liters/min; 7.2 [±3.2] liters/min; P = .26). We found a statistically significant decrease in concentration of hemoglobin (7.2 [±0.8] mmol/liter; 6.2 [±0.9] mmol/liter; P = .0002), and a statistically significant increase in concentration of lactate (1.3 [±0.5] mmol/liter; 1.7 [±1] mmol/liter; P = .02). The perioperative blood transfusion guided by standard monitoring seemed to sustain CO from baseline till end of surgery; however, further research is needed to confirm this.

INTRODUCTION: Trauma patients may require interhospital transfer to definitive care following initial assessment at a primary facility. A prolonged time to transfer may be associated with a poor outcome. The aim of this study was to determine the time from injury to arrival in patients undergoing interhospital transfer to the Trauma Centre at Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.METHODS: Data were obtained from our local trauma registry for the period from 1 November 2016 to 31 October 2019. We included patients who underwent interhospital transfer to our trauma centre. Patients were compared according to a 360-minute time interval between injury and arrival.RESULTS: In the study period, 250 patients underwent interhospital transfer to our trauma centre. The median age was 47 years (interquartile range (IQR) 26-65), the majority were male (68.4%) and a total of 113 patients (46.9%) had an Injury Severity Score (ISS) > 15. The 30-day mortality was 6% (95% confidence interval (CI) 3.6-9.7). The median time from injury to arrival at our trauma centre was 255 minutes (IQR 192-371). We found that 67 patients (27%; 95% CI 21.7-32.6) arrived at our trauma centre more than 360 minutes after time of injury. The patients arriving later than 360 minutes were significantly older (p = 0.004) than the remaining patients. There was no significant difference in the unadjusted 30-day mortality (odds ratio (OR) 1.01, 95% CI 0.3-3.3).CONCLUSIONS: Time from injury to arrival at our trauma centre exceeded 360 minutes for 67 patients (27%) who were significantly older than the remaining patients transferred.FUNDING: departmental funding.TRIAL REGISTRATION: not relevant.

Introduction Track and trigger systems (TTSs) based on vital signs are implemented in hospitals worldwide to identify patients with clinical deterioration. TTSs may provide prognostic information but do not actively include clinical assessment, and their impact on severe adverse events remain uncertain. The demand for prospective, multicentre studies to demonstrate the effectiveness of TTSs has grown the last decade. Individual Early Warning Score (I-EWS) is a newly developed TTS with an aggregated score based on vital signs that can be adjusted according to the clinical assessment of the patient. The objective is to compare I-EWS with the existing National Early Warning Score (NEWS) algorithm regarding clinical outcomes and use of resources. Method and analysis In a prospective, multicentre, cluster-randomised, crossover, non-inferiority study. Eight hospitals are randomised to use either NEWS in combination with the Capital Region of Denmark NEWS Override System (CROS) or implement I-EWS for 6.5 months, followed by a crossover. Based on their clinical assessment, the nursing staff can adjust the aggregated score with a maximum of-4 or +6 points. We expect to include 150 000 unique patients. The primary endpoint is all-cause mortality at 30 days. Coprimary endpoint is the average number of times per day a patient is NEWS/I-EWS-scored, and secondary outcomes are all-cause mortality at 48 hours and at 7 days as well as length of stay. Ethics and dissemination The study was presented for the Regional Ethics committee who decided that no formal approval was needed according to Danish law (J.no. 1701733). The I-EWS study is a large prospective, randomised multicentre study that investigates the effect of integrating a clinical assessment performed by the nursing staff in a TTS, in a head-to-head comparison with the internationally used NEWS with the opportunity to use CROS.