使い捨て陰茎縫合器を用いた小児割礼における術中鎮痛のための経口NSAIDと直腸NSAIDの比較：ランダム化比較試験

This study aimed to evaluate the analgesic efficacy and safety of rectally administered diclofenac sodium suppositories during the perioperative period of pediatric circumcision using a disposable circumcision suture device (DCSD), and to provide guidance on their safe and effective use in pediatric practice.

In this prospective randomized controlled trial, 140 boys aged 7-12 years undergoing DCSD circumcision were randomly assigned to either the experimental group (n = 70; rectal diclofenac sodium, 1 mg/kg) or the control group (n = 70; oral ibuprofen, 10 mg/kg). All patients received local penile root block anesthesia with lidocaine. Pain was assessed using the Visual Analog Scale (VAS) by trained nurses blinded to group allocation, with parental assistance to minimize bias. Rescue analgesia use, adverse events, and postoperative sleep quality were also recorded.

Reductions in VAS scores at scheduled time points did not differ significantly between groups, indicating comparable short-term analgesic efficacy. However, the diclofenac group required fewer rescue interventions, experienced a lower incidence of adverse events (10.0% vs. 30.0%), and demonstrated better postoperative sleep quality. Administration before dressing changes also improved patient cooperation.

Rectal diclofenac sodium suppositories are an effective and well-tolerated option for perioperative analgesia in pediatric circumcision using DCSD, providing improved comfort, sleep quality, and caregiver satisfaction compared to oral ibuprofen. However, due to the study's single-center design, short follow-up period, and the use of different NSAIDs between groups, the results should be interpreted with caution. Larger multicenter trials are necessary to confirm these findings and inform broader clinical application.

(TCTR20250513005) [Registered on 13/05/2025]. This trial is registered with the Thailand Clinical Trials Registry https//www.thaiclinicaltrials.org/.