Feasibility of a Ketamine Anesthesia Package in Support of Obstetric and Gynecologic Procedures in Kenya When No Anesthetist is Available.

The objective was to assess the feasibility and safety of the ̳Every Second Matters for Emergency and Essential Surgery - Ketamine' (ESM-Ketamine) package in support of obstetric and gynecologic emergency and essential surgery when no anesthetist is available. A consecutive case series was conducted in twelve hospitals across five severely resource-limited counties in Kenya. 530 women underwent obstetric or gynecological operative procedures supported by non-anesthetist clinicians using the ESM-Ketamine package between November 1, 2013 and September 30, 2017. Main outcomes included reasons for ESM-Ketamine activations and ketamine-related adverse events. There were two (0.4%) prolonged (>30 seconds) oxygen desaturations below 92%. Brief oxygen desaturations (<30 seconds) below 92% occurred in 15 (2.8%) cases and 113 (21.3%) were administered diazepam to treat hallucinations or agitation. There were no ketamine-related deaths or injuries. The ESM- Ketamine package appears feasible and safe for use in support of obstetric and gynecologic surgeries when no anesthetist is available.

Validation of a novel medical device (Chloe SED®) for the administration of analgesia during manual vacuum aspiration: a randomized controlled non-inferiority pilot study.

Introduction: Millions of women worldwide annually undergo manual vacuum aspiration (MVA) with no pain medication, which is a violation of their basic human dignity. We designed a novel device (Chloe SED®) to administer paracervical block (PCB) during MVA in countries where pain medication is not typically given due to the high cost of the necessary tools. Methods: We conducted a single-blinded, randomized controlled non-inferiority trial including 61 patients at two hospitals in Kisumu, Kenya, to validate Chloe SED® for administration of PCB during MVA. PCB administered with Chloe SED® was compared to PCB administered with a standard spinal needle. Patients requiring MVA were block randomized in blocks of six, each provider completing six PCBs-three with the Chloe SED® and three with the standard spinal needle. The trial was registered with the Kenya Pharmacy and Poisons Board, ECCT/19/03/01 (https://ctr.pharmacyboardkenya.org/applications/index/protocol_no:RUNDVC8xOS8wMy8wMQ__/filter:/investigator:/sites:/pages:5/start_date:/end_date:/disease_condition:/users:/ercs:/stages). An intention-to-treat analysis was completed. The primary outcome was the non-inferiority of the pain score during uterine evacuation with a non-inferiority margin of 2 points on an 11-point numerical rating scale. Secondary outcomes included the non-inferiority of the pain score at four other time points and patient satisfaction. Results: Chloe SED® showed non-inferiority of the primary outcome with a mean pain score during evacuation of 3.8 [90% confidence interval (CI): 3.1-4.6] compared with the spinal needle at 4.1 (90% CI: 3.5-4.7). Non-inferiority of the pain score was shown at all time points. Most patients expressed a desire for the continued use of the device to administer PCB for MVA. No adverse events were noted. Conclusion: In summary, the Chloe SED® appears non-inferior to the spinal needle and desirable for the administration of PCB during MVA.

Intraoperative awareness and experience with a ketamine-based anaesthesia package to support emergency and essential surgery when no anaesthetist is available.

INTRODUCTION: Five of the 7.2 billion people on earth have limited access to emergency and essential surgical procedures. The lack of safe, affordable and timely anaesthesia services are primary barriers to universal surgical coverage. The objective of this study was to assess intraoperative awareness when the 'Every Second Matters for Emergency and Essential Surgery - Ketamine' (ESM-Ketamine) package was used to support emergency and essential surgeries and painful procedures in rural Kenya when no anaesthetist was available. METHODS: Forty-seven consecutive adult patients that underwent an operative procedure under ESM-Ketamine at Sagam Community Hospital in Luanda, Kenya were enrolled. Participants underwent two semi-structured interviews that explored the patient's experience with ESM-Ketamine both after the operative procedure and four to six weeks after surgery. RESULTS: Forty-seven participants completed the first interview and 37 (78.7%) the second interview. Thirty-seven (78.7%) cases were procedural sedations and ten were (21.3%) emergency surgeries. Intraoperative awareness occurred in nine (24.3%) participants who underwent procedural sedation and two (20%) who underwent emergency surgery. Twenty-six (55.3%) participants reported dreams during the procedure. Thirty-two (86.5%) participants considered their experience positive, and 35 (95%) would recommend a procedure supported by ketamine to a friend. DISCUSSION: Most patients whose painful procedures and emergency operations were supported by the ESM-Ketamine package when no anaesthetist was available reported favourable experiences.

Evaluation of a ketamine-based anesthesia package for use in emergency cesarean delivery or emergency laparotomy when no anesthetist is available.

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.

An innovative safe anesthesia and analgesia package for emergency pediatric procedures and surgeries when no anesthetist is available.

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.