Calen Sacevich1, Benjamin Semakuba2, William P McKay3, Shefali Thakore1, Theogene Twagirumugabe2, John Nyiligira4. 1. Department of Anesthesia, University of Saskatchewan, Saskatoon, SK, Canada. 2. Department of Anesthesiology, University of Rwanda, Kigali, Rwanda. 3. Department of Anesthesia, University of Saskatchewan, Saskatoon, SK, Canada. william.mckay@saskatoonhealthregion.ca. 4. Department of Pharmacy, University Teaching Hospital of Kigali, Kigali, Rwanda.
Abstract
PURPOSE:Postoperative pain control is often inadequate in low-income countries such as Rwanda, prompting the search for an inexpensive improvement. A randomized controlled trial was conducted to study the use of subcutaneous ketamine for the management of postoperative pain in patients undergoing major surgery in Kigali, Rwanda. METHODS:Fifty-nine patients undergoing major abdominal, head and neck, plastic, or gynecological surgeries were studied. In addition to standard care, patients received five subcutaneous injections of ketamine 1 mg·kg-1 (ketamine group, n = 30) or normal saline (placebo group, n = 29) during the postoperative period. The first injection was administered in the postanesthesia care unit and then every 12 hr thereafter starting at 20:00 on the day of surgery. Pain was assessed three times per day using an 11-point verbal response scale. Patients were also assessed for side effects, including nausea and vomiting, hallucinations, nightmares, sedation, hypertension, and seizures. RESULTS: The mean (SD) overall postoperative pain scale score was higher in the control group than in the ketamine group [4.8 (1.7) vs 3.7 (1.5), respectively; difference of means, 1.1; 95% confidence interval [CI], 0.3 to 1.9; P = 0.009]. Brief hallucinations (ketamine group, 11 patients; placebo group, 0 patients; risk difference, 0.37; 95% CI, 0.18 to 0.54; P < 0.001) were associated with ketamine administration. CONCLUSIONS: Results of this study in Kigali, Rwanda showed that subcutaneous administration of ketamine 1 mg·kg-1 twice daily, in addition to standard postoperative care, produced a small improvement in postoperative pain but resulted in more minor side effects TRIAL REGISTRATION: www.clinicaltrials.gov (NCT02514122). Registered 31 July 2015.
RCT Entities:
PURPOSE:Postoperative pain control is often inadequate in low-income countries such as Rwanda, prompting the search for an inexpensive improvement. A randomized controlled trial was conducted to study the use of subcutaneous ketamine for the management of postoperative pain in patients undergoing major surgery in Kigali, Rwanda. METHODS: Fifty-nine patients undergoing major abdominal, head and neck, plastic, or gynecological surgeries were studied. In addition to standard care, patients received five subcutaneous injections of ketamine 1 mg·kg-1 (ketamine group, n = 30) or normal saline (placebo group, n = 29) during the postoperative period. The first injection was administered in the postanesthesia care unit and then every 12 hr thereafter starting at 20:00 on the day of surgery. Pain was assessed three times per day using an 11-point verbal response scale. Patients were also assessed for side effects, including nausea and vomiting, hallucinations, nightmares, sedation, hypertension, and seizures. RESULTS: The mean (SD) overall postoperative pain scale score was higher in the control group than in the ketamine group [4.8 (1.7) vs 3.7 (1.5), respectively; difference of means, 1.1; 95% confidence interval [CI], 0.3 to 1.9; P = 0.009]. Brief hallucinations (ketamine group, 11 patients; placebo group, 0 patients; risk difference, 0.37; 95% CI, 0.18 to 0.54; P < 0.001) were associated with ketamine administration. CONCLUSIONS: Results of this study in Kigali, Rwanda showed that subcutaneous administration of ketamine 1 mg·kg-1 twice daily, in addition to standard postoperative care, produced a small improvement in postoperative pain but resulted in more minor side effects TRIAL REGISTRATION: www.clinicaltrials.gov (NCT02514122). Registered 31 July 2015.