Scheduled Around the Clock Versus Routine Analgesic Dosing for Post Caesarean Pain Control at Kenyatta National Hospital, a Randomised Clinical Trial

Abstract

Background: Post caesarean pain management is still suboptimal despite the available knowledge, research and advanced therapeutic methods. Current guidelines advocate for multimodal approach to postoperative pain treatment. At Kenyatta National Hospital, the procedure specific pain protocol for caesarean section is multimodal but not scheduled and with marked diversity in post caesarean analgesic prescription. A scheduled around the clock multimodal analgesic regimen ensures continuous pain control with optimal doses of analgesia, reduces end of dose treatment failure and opioid consumption. Objective: To compare the differences in mean pain scores between post-caesarean patients randomized to scheduled around the clock versus routine analgesia at the Kenyatta National Hospital. Methods: A single blind parallel, randomized controlled trial was carried out at the Kenyatta National Hospital maternity unit. Ninety-eight patients scheduled for caesarean delivery were randomised into scheduled around the clock or routine analgesia study arm. Scheduled around the clock group received six hourly subcutaneous morphine for 12 hours followed by intravenous paracetamol six hourly and rectal diclofenac 12 hourly for 24 hours. The routine arm received analgesics as prescribed by the operating surgeon and mean pain intensity scores evaluated before the first analgesic dose, at 4, 10, 24 and 48 hours using the visual analogue scale. Satisfaction with pain management was evaluated using a Likert scale at 72hrs after the surgery. Data was analysed using Statistical Package for Social Scientists software, version 25. Demographic data of patients who received scheduled around the clock analgesia and routine analgesia were compared using the Fishers test and age identified as a potential confounder. The Fishers Exact test and Cox regression were used to compare the mode of anaesthesia of patients on scheduled around the clock analgesia and routine analgesia. The independent samples T test and Analysis of Covariance were used to compare dosage of analgesia of patients on scheduled around the clock analgesia and routine analgesia, with the Fishers Exact test and Cox regression used to compare satisfaction with management of patients on scheduled around the clock and routine analgesia at 95% confidence level. All analyses were intention to treat. Results: Between September and November 2019, 101 patients were screened and 98 randomized. The mean age was statistically significantly lower among patients who received routine analgesia, 26.7 (SD 5.5) compared to scheduled around the clock analgesia, 30.3 (SD 6.1), P<0.01. Scheduled around the clock had lower mean pain scores compared to routine analgesia at four hours, 3.6 (SD 2) vs 4.8 (SD 2.6), P<0.01). At 10 hours (4.2 vs 4.6), 24 hours (3.1 vs 3.6) and 48 hours (1.9 vs 2.4), the mean pain scores were lower for SATC than routine groups but not significant statistically. The mean (SD) dosage of prescribed morphine was significantly lower in scheduled around the clock, 2 (0) than routine group 2.9 (0.4) P<0.01. Prescribed diclofenac doses were significantly more for scheduled around the clock group mean 5 (SD 0) than routine mean 4.4 (SD 1.2) P<0.01.The dose of rescue diclofenac was higher in the routine than scheduled analgesia group mean 1 (SD 0) vs 4(SD 0) P<0.01. Side effects were similar between the two treatment regimens...................................................................................................................................................