A randomized controlled trial of rectal versus intramuscular diclofenac for post-operative analgesia after open myomectomy.

AIM: To determine the efficacy and safety of rectal versus intramuscularly administered Diclofenac in reducing post-operative pain in the first 24 h after open-myomectomy. METHODS: A single blind, placebo controlled randomized trial consisting of 90 consenting women that had open-abdominal-myomectomy. They were randomized into two-groups (rectal-group and intramuscular-group) of 45 women (1:1 ratio). Rectal-group received 75 mg of Diclofenac suppository 12 hourly for 24 h and placebo (3 ml of intramuscular injection-water) 12hourly for 24 h while intramuscular-group received intramuscular Diclofenac 75 mg 12 hourly for 24 h and placebo (Anusol suppository) 12 hourly for 24 h. Both groups received intramuscular Pentazocine 30 mg 6 hourly for 24 h as primary analgesic after myomectomy. Pain was assessed using a Ten-Point Visual-Analogue-Scale. Participants' satisfaction of the mode of the pain relief was assessed using the Likert-scale after 24 h. The primary outcome was the pain score using the visual-analogue-scale. The secondary outcome-measures were participants' satisfaction after 24 h of administration of the drugs, the need and frequency of rescue-analgesia and maternal-side-effects. RESULT: The baseline socio-demographic characteristics were similar in both groups. There was no statistically significant difference between both groups in pain assessment at 1 h post-myomectomy (p-value > 0.05). However, the pain assessments at 6, 12, 18 and 24 h post-myomectomy were statistically significant with more pain in intramuscular-group when compared to rectal-group. Majority of participants in rectal-group were both very satisfied (35.6 %) and satisfied (55.6 %) when compared to intramuscular-group (11.1 %) and (31,1%) respectively (p-value < 0.05). Also majority of the participants in intramuscular-group were dissatisfied (17.8 %) with none of the participant showing any form of dissatisfaction (p-value < 0.05). Majority of the participant in rectal-group had no drug side effects when compared with intramuscular-group. Epigastric discomfort was commoner in rectal-group while drowsiness was commoner in intramuscular-group. CONCLUSION: Rectal Diclofenac with intramuscular Pentazocine is significantly associated with better effectiveness in pain reduction and maternal satisfaction when compared with intramuscular Diclofenac and intramuscular Pentazocine following open-myomectomy. While epigastric discomfort was the commonest side-effect in rectal-group, drowsiness was commoner in intramuscular-group. TRIAL REGISTRATION: Pan-African-clinical-trial-registry (PACTR); PACTR202206556144219.

Preoperative vaginal cleansing with chlorhexidine solution in preventing post-cesarean section infections in a low resource setting: A randomized controlled trial.

INTRODUCTION: Infection is one of the most common causes of maternal morbidities and mortality and has been reported to be responsible for about 15% of maternal deaths. Any woman is at risk of infection during childbirth, but women undergoing cesarean section are at higher risk. Improvement in surgical procedures with asepsis and the use of antibiotics have helped reduce postoperative infectious morbidities. However, ascending infection from the lower to the upper genital tract is a common but often neglected source of infection. Cleaning the vagina with chlorhexidine antiseptic solution before cesarean section can be a cheap and affordable source of infection control. This study is aimed at evaluating the efficacy of preoperative vaginal cleansing using 1.0% chlorhexidine in the reduction of post-cesarean section infectious morbidities. MATERIAL AND METHODS: This prospective randomized control trial was conducted among 322 pregnant women who underwent an emergency cesarean section at Alex Ekwueme Federal University Teaching Hospital, Abakaliki (AE-FUTHA). The women were randomized into two groups. The interventional group received vaginal cleansing with three standard gauzes soaked in 30 mL 1.0% chlorhexidine gluconate solution preoperatively in addition to surgical skin cleaning with chlorhexidine-alcohol. The women in the control group only had surgical skin cleaning with chlorhexidine-alcohol. All the women received pre- and postoperative antibiotics. The primary outcomes were endometritis and wound infections. RESULTS: Infectious morbidity was significantly reduced from 36.8% in the control group to 12.0% in the intervention group (P = .001). Endometritis occurred significantly less frequently in the intervention group than the control group (respectively 6.6% compared with 27.6%: relative risk [RR] 0.29, 95% confidence interval [CI] 0.16-0.53; P < .05). Foul-smelling vaginal discharge was significantly more common in the control group than in the intervention group (11.8% vs 1.3%, respectively) but the CI was wide (RR 8.5, 95% CI 1.30-64.55; P < .001). Fever and wound infection were more common in the control group (5.9% vs 3.3% and 9.2% vs 5.3%) but the difference was not significant. The hospital stay was significantly shorter among the intervention group (5.54 ± 1.04 days compared with 6.01 ± 1.55 days, P < 0.05). The most common microbial isolate implicated in endocervical colonization was Staphylococcus aureus followed by Klebsiella species. CONCLUSIONS: Vaginal cleansing with 1.0% chlorhexidine gluconate solution before emergency cesarean section appears to be effective in reducing rates of post-cesarean section infectious morbidity in the study area. We recommend its use among women undergoing cesarean section to help reduce the contribution of infections to a poor obstetrics outcome.