A ketamine package for use in emergency cesarean delivery when no anesthetist is available: An analysis of 401 consecutive operations

Objective: To evaluate the safety and effectiveness of a ketamine-based anesthesia package to support emergency cesarean section when no anesthetist is available. Methods: A prospective case-series was conducted between December 11, 2013 and September 30, 2021 across nine sub-county hospitals in Kenya. Non-anesthetist healthcare providers undertook an evidence-based five-day training course. A structured instrument was used to collect preoperative, intraoperative, and postoperative data, and patients were contacted 6 months following the surgery to collect outcomes. The primary outcome measures were maternal and newborn survival and the ability of the ketamine package (ESM-Ketamine) to safely support cesarean deliveries. Results: A total of 401 emergency cesarean sections were performed using ketamine, administered by 54 non-anesthetist providers. All mothers survived to discharge. Brief oxygen desaturations were recorded among 33 (8.2%) mothers, and agitation and hallucinations occurred among 13 (3.2%). There were no maternal serious adverse events. At 6-month follow-up, 94.2% of mothers who could be reached reported no complaints. Additionally, 402 (92.4%) of the 435 operative births survived to discharge. Conclusion: The ESM-Ketamine package can be used by trained non-anesthetist providers to support emergency cesarean sections when no anesthetist is available. Ketamine has significant potential to increase access to emergency cesarean deliveries in resource-limited settings. Data was collected prospectively from seven sub‐county and two private hospitals in Kenya. The locations of these facilities are depicted in Figure 1, and the characteristics of these facilities are presented in Table S1. The rationale for selecting these nine study sites has been previously described. 10 The Sagam Community Hospital implemented the ESM‐Ketamine program first, doing so on December 11, 2013, and the Kendu Sub‐County hospital was the last to implement the program, doing so on September 15, 2019 (Table 1). All data until September 30, 2021 were considered in this study. Location of facilities using ESM‐Ketamine package of emergency cesarean delivery Location of included emergency operative procedures When on‐line with ESM‐Ketamine, study hospitals had a functional operating theater, available perioperative services, a staff clinician able to perform emergency cesarean delivery and other emergency procedures, but limited access to anesthesia services. The study protocol was approved by the Kenyan Ministry of Health and the institutional review boards of Partners Healthcare and the Maseno University School of Medicine. These two institutional review boards, the Division of Reproductive Health of the Kenya Ministry of Health, the leaders of the participating hospitals, and the County Health Directors provided approval for the nurse‐midwives, clinical officers (mid‐level non‐physician providers), medical officers (generalist medical doctors who completed medical school and one year of an internship), and non‐anesthetist physicians to become ESM‐Ketamine providers. A detailed description of the development and implementation of the ESM‐Ketamine program has been reported elsewhere. 11 The package includes an ESM‐Ketamine kit, an intensive 5‐day training program for trainees, checklists, and wall charts. All trainees for the ESM‐Ketamine program were non‐anesthetist healthcare providers such as nurse‐midwives, clinical officers, and medical officers. The 5‐day training course educated providers on the basic pharmacology of ketamine, contraindications, dosing schedule, patient monitoring, and essential ventilation support for both adults and newborns. Additional training on the use and dosing schedule of supplemental medications to control adverse effects included diazepam for agitation or hallucinations, hydralazine for severely elevated blood pressure, atropine for hypersalivation, and promethazine and prochlorperazine for nausea and vomiting. Each ESM‐Ketamine provider was also fully trained in Helping Babies Breathe. The skills of providers were reinforced through hands‐on case‐based simulation followed by mentored procedures in the operating theater. According to the protocol, when the need for an emergency cesarean section was identified at a participating site, attempts were first made to contact a trained anesthetist. If no anesthesia providers were available after multiple attempts and safe transfer to another facility was not possible, the ESM‐Ketamine protocol was activated. During each of the ESM‐Ketamine‐supported cesarean sections, the overall responsibility for the patient was held by the surgical provider who performed the operation. The ESM‐Ketamine provider administered the anesthetic and monitored the patient intraoperatively and during recovery. Preoperative, intraoperative, and postoperative data as well as discharge conditions were collected from all patients using a structured instrument. To record maternal and newborn outcomes at 6 months, attempts were made to contact all enrolled mothers. If the cesarean section occurred during the last 6 months of the study period, the final follow‐up was in less than 6 months. A standardized script was used to verify the mothers’ identity and date of the cesarean procedure, and mothers were surveyed about their own health and that of the newborn. To ensure all maternal and newborn deaths and their causes were identified, hospital records and county maternal, newborn, and stillborn death audits were reviewed independently of the ESM‐Ketamine providers and implementing teams. All ESM‐Ketamine‐supported emergency cesarean deliveries conducted within the participating facilities were extracted from the database for analysis. The primary outcome measures were maternal and newborn survival and the ability of ESM‐Ketamine to safely support cesarean deliveries. Adverse events were defined as hallucinations or agitation treated with diazepam, hypersalivation treated with atropine, peripartum hypertension treated with hydralazine, and brief periods of oxygen desaturations (SpO2 < 92% for <30 s). Serious adverse events were defined as maternal death, prolonged periods of oxygen desaturations (SpO2 < 92% for >30 s), and any bag‐valve mask ventilation support. Other variables collected included facility demographics, maternal age and weight, total ketamine dose administered, length of procedure, and notes from 6‐month follow‐up calls. The database was constructed using Excel 2015 (Microsoft, Redmond, WA, USA). Data were analyzed using Python 3.7. Standard descriptive and frequency analyses were performed. A chi‐squared test of independence was used to compare newborn mortality rates between ESM‐Ketamine provider types (nurse‐midwives, medical officers, and clinical officers). A P‐value of <0.05 was considered significant.