A novel dexmedetomidine nasal spray for gastrointestinal recovery in pediatric laparoscopic hernia repair: a randomized controlled trial

Preoperative anxiety is common in pediatric surgical patients and may delay postoperative recovery. Conventional intranasal or nebulized dexmedetomidine often requires off-label dilution and manual assembly, which can lead to dosing inconsistency and variable mucosal absorption. We evaluated a novel dexmedetomidine nasal spray in children undergoing laparoscopic inguinal hernia repair. In this study, 100 children aged 2–6 years scheduled for laparoscopic high ligation of the hernia sac for indirect inguinal hernia received either dexmedetomidine spray (Group D, n = 50) or saline (Group C, n = 50) 30 min before anesthesia. Primary outcome was time to first flatus; secondary outcomes included time to first defecation, time to tolerated oral intake, I-FEED scores on postoperative days 1–3, preoperative anxiety in children and parents, postoperative pain, and behavioral changes. Group D showed significantly shorter time to first flatus (14.61 ± 4.19 h vs. 17.57 ± 5.96 h, P = 0.006), defecation (23.94 ± 7.22 h vs. 29.70 ± 7.63 h, P < 0.001) and time to tolerated oral intake (12.82 ± 5.94 h vs. 14.92 ± 7.02 h, P = 0.047). FLACC scores and I-FEED scores were also lower on day 1 (P = 0.015, P = 0.022, respectively). Intranasal dexmedetomidine attenuates preoperative anxiety in both children and parents and facilitates smoother separation from parents. No significant differences were found in behavioral changes. No serious adverse events occurred in the PACU. A novel dexmedetomidine nasal spray improved gastrointestinal recovery and reduced preoperative anxiety and early postoperative pain without compromising safety, suggesting a practical and reproducible sedation strategy for pediatric perioperative care. ChiCTR2400088326 Date: August 15, 2024.