Noninferiority trial of low-dose intravenous dexamethasone on the analgesic effect of caudal block in children undergoing day-case orchiopexy: a randomized clinical trial

Background: Intravenous (IV) administration of dexamethasone has been reported to prolong the analgesic duration of a caudal block. The aim of this study was to compare the analgesic effects of IV low-dose and high-dose dexamethasone in pediatric patients undergoing orchiopexy.Methods: In this randomized controlled trial, 273 children aged 6 months to 6 years who underwent orchiopexy under general anesthesia with a caudal block at Severance Hospital (Seoul, South Korea) were assigned to receive either low-dose dexamethasone (0.15 mg/kg, Group L) or high-dose dexamethasone (0.5 mg/kg, Group H) during general anesthesia. Parents were trained to assess postoperative pain using the Face, Legs, Activity, Cry, Consolability (FLACC) scale and instructed to administer analgesics when the pain score was 4 or higher. The primary outcome was the need for additional analgesics within 48 h postoperatively in both groups. Secondary outcomes included the time to first analgesic administration, postoperative pain scores, incidence of nausea or vomiting, parental assessment of postoperative pain, and overall parental satisfaction.Results: The proportion of patients requiring additional analgesics did not differ significantly between the groups (41.5% in Group H vs. 49.2% in Group L, odds ratio 1.37; 95% confidence interval, 0.83–2.27; P = 0.22). No significant differences were observed in secondary outcomes.Conclusions: Although no significant differences in analgesic effect were observed between low- and high-dose dexamethasone groups, the noninferiority of low-dose could not be conclusively demonstrated.