Effect of Oliceridine on Early Postoperative Recovery in Children Undergoing Adenotonsillectomy: A Prospective, Double-Blind, Randomized Controlled Trial
Abstract
Background Children undergoing adenotonsillectomy may be vulnerable to opioid-related adverse effects, creating a need for analgesic strategies that support rapid postoperative recovery. This study compared the perioperative effects of oliceridine and sufentanil in children undergoing adenotonsillectomy under general anesthesia. Methods This single-center, double-blind, randomized controlled trial included 79 children aged 3–10 years with ASA physical status I–II undergoing elective adenotonsillectomy under general anesthesia with tracheal intubation. Participants were randomly assigned 1:1 to receive oliceridine 0.1 mg/kg (n = 39) or sufentanil 0.5 μg/kg (n = 40) during anesthesia induction. The co-primary endpoints were extubation time and PACU stay duration. Secondary endpoints included perioperative hemodynamics, Pediatric Anesthesia Emergence Delirium (PAED) score, Face, Legs, Activity, Cry, Consolability (FLACC) score, opioid exposure, rescue analgesic use, and postoperative adverse events. Results Extubation time was shorter with oliceridine than with sufentanil (35.4 ± 8.5 vs 42.6 ± 14.9 min; mean difference, −7.16 min; 95% CI, −12.59 to −1.74; p = 0.010). PACU stay duration was also shorter with oliceridine (median, 55 [47.5, 65] vs 65 [53.8, 70] min; estimated location shift, −10.00 min; 95% CI, −15.00 to <0.00; p = 0.011). Both co-primary endpoint p-values remained below the post hoc Bonferroni threshold of 0.025. Exploratory age-stratified analyses showed no significant treatment-by-age interactions for either recovery outcome. PAED and FLACC scores and SpO2 before PACU discharge did not differ significantly between groups. Postoperative adverse events were infrequent, and no participant required rescue analgesia. Conclusion Compared with sufentanil, oliceridine was associated with shorter extubation time and PACU stay duration in children aged 3–10 years undergoing adenotonsillectomy under general anesthesia. These findings suggest that oliceridine may facilitate early postoperative recovery, although larger studies are needed to further characterize its comparative safety.