Effect of pre-operative rectal diclofenac suppository on post-operative analgesic requirement in cleft palate repair: A randomised clinical trial

BACKGROUND: Opioid analgesics used for analgesia are associated with sedation, respiratory depression and post-operative nausea and vomiting. Non-steroidal anti-inflammatory drugs such as diclofenac are a safe and effective alternative with opioid-sparing effect. OBJECTIVE: To evaluate the effectiveness of pre-operative rectal diclofenac suppository (1 mg/kg) in cleft palate repair for post-operative analgesia and reduction in post-operative opioid requirements. STUDY DESIGN: A randomized clinical trial. METHODS: After obtaining approval from the institutional ethical committee, 60 children were allocated by a computer-generated randomisation into two groups of 30 each; group D (Diclofenac group) and group C (Conventional group). Children in group D and group C were similar in all aspects except for the fact that group D children received 1 mg/kg diclofenac suppository after induction. Pain was evaluated using modification of the objective pain scale by Hannallah and colleagues for 6 h post-operatively by an anaesthesiology resident or nursing staff who was blinded to the group. If the pain score was more than 3, rescue analgesic I.V. fentanyl 0.5 μgm/kg was administered. The pain scores at different intervals, number of doses and quantity of rescue analgesic required were noted. RESULTS: We observed that pre-operative rectal diclofenac provided effective analgesia in the immediate post-operative period, as evidenced by reduced pain scores and reduced opioid requirement (P=0.00002). There was no evidence of any increased perioperative bleeding in the diclofenac group. CONCLUSION: Pre-operative rectal diclofenac reduces opioid consumption and provides good post-operative analgesia.