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INTRODUCTION: Women in Kenya and other low- and middle-income countries often do not receive analgesia during manual vacuum aspiration (MVA). This pilot study evaluated the efficacy of a novel, ultra-low-cost syringe extension device (Chloe-SED) developed by this research team for provision of paracervical block (PCB) during MVA. METHODS: A randomized, single-blinded non-inferiority trial of 61 patients was conducted at two facilities in Kisumu between September 2019 and January 2021 comparing PCB administered with Chloe-SED to a standard spinal needle. The primary outcome was non-inferiority of pain score during uterine evacuation within a non-inferiority margin of 2 points on an 11-point visual assessment scale. Secondary outcomes included non-inferiority of pain score at 4 other time points, patient satisfaction, and provider feedback on Chloe-SED. Institutional review board approval was obtained and written consent was obtained from all participants. RESULTS: Chloe-SED showed non-inferiority of the primary outcome with mean pain score during evacuation of 3.9 (3.2-4.7) compared with spinal needle at 4.1 (3.5-4.7). Non-inferiority was shown at all time points. In one patient the syringe and device were incompatible. In one case, breakage of the finger-pad of the device after completion of PCB was noted with no injury to patient or provider. Most patients and providers expressed desire for continued use of the device to administer PCB for MVA. CONCLUSION: The Chloe SED device appears effective and desirable for administration of PCB during MVA. Further study and development of Chloe SED will allow humane pain control during MVA in regions worldwide where this previously was not possible. [ABSTRACT FROM AUTHOR]

Objective: To assess the safety of a ketamine-based rescue anesthesia package to support emergency cesarean delivery and emergency laparotomy when no anesthetist was available.Methods: A prospective case-series study was conducted at seven sub-county hospitals in western Kenya between December 10, 2013, and January 20, 2016. Non-anesthetist clinicians underwent 5days of training in the Every Second Matters-Ketamine (ESM-Ketamine) program. A database captured preoperative, intraoperative, and postoperative details of all surgeries in which ESM-Ketamine was used. The primary outcome measure was the ability of ESM-Ketamine to safely support emergency operative procedures.Results: Non-anesthetist providers trained on ESM-Ketamine supported 83 emergency cesarean deliveries and 26 emergency laparotomies. Ketamine was administered by 10 nurse-midwives and six clinical officers. Brief oxygen desaturations (<92% for <30s) were recorded among 5 (4.6%) of the 109 patients. Hallucinations occurred among 9 (8.3%) patients. No serious adverse events related to the use of ESM-Ketamine were recorded.Conclusion: The ESM-Ketamine package can be safely used by trained non-anesthetist providers to support emergency cesarean delivery and emergency laparotomy when no anesthetist is available. [ABSTRACT FROM AUTHOR]

Background: Adequate pain control through sedation and anesthesia for emergency procedures is a crucial aspect of pediatric emergency care. Resources for administering such anesthesia are extremely limited in many low-income settings. Methods: Non-anesthetist providers in Western Kenya were trained in the use of a ketamine-based sedation and anesthesia package for non-anesthetists, Every Second Matters for Mothers and Babies-Ketamine™ (ESM-Ketamine). Data on use and safety of this package for emergent and urgent pediatric procedures was collected. Providers were surveyed as to what they would have done for similar procedures if the ESM-Ketamine package were unavailable. Results: Ninety procedures were completed for 77 pediatric patients utilizing the ESM-Ketamine package. Of these, 29 (32.2 %) cases were orthopedic reductions, 19 (21.1 %) were incision and drainage, and 19 (21.1 %) were debridement and irrigation of burns. Remaining cases included cesarean section, repair of perineal tear, foreign body removal, arthrocentesis, laceration repair, exploratory laparotomy, excision of mass, paracentesis, and circumcision. There were no serious adverse events in any of the cases, 17 % experienced minor adverse events including hypersalivation, hallucinations, or brief, self-resolving, oxygen desaturations. Providers were surveyed for 80 of the 90 cases as to what they would have done in the absence of the ESM-Ketamine package: in 26 cases (32.5 %), they reported they would proceed with the procedure without any anesthesia or analgesia; in 15 (18.75 %), they reported they would significantly delay the procedure while waiting for an anesthetist; in 13 (16.25 %), they reported they would attempt referral to another facility; and in 26 (32.5 %), they reported they would try using an alternate form of analgesia, primarily acetaminophen, ibuprofen, diclofenac, and/or diazepam. All surveyed providers reported they would use the ESM-Ketamine package again in similar cases. Conclusions: The ESM-Ketamine package, through the use of a simplified protocol and checklist, allows for safe analgesia and anesthesia in children by non-anesthetists in a resource-limited setting for selected emergent and urgent procedures. This package addresses a significant gap in the availability of anesthesia services in low-income settings that would otherwise result in significant delays to procedures or proceeding with painful procedures with inadequate analgesia. [ABSTRACT FROM AUTHOR]