Comparison of opioid-free anesthesia with opioid-based anesthesia in neonates and infants undergoing laparoscopic or endoscopic surgeries: A randomized controlled trial.

Background: Postoperative pain after laparoscopic surgery can include referred shoulder pain, visceral pain, and incisional pain, often due to CO₂ insufflation and peritoneal irritation. Although opioids are widely used for pain management, their side effects, such as sedation, nausea, and constipation, can delay recovery and increase costs. Opioid-free anesthesia (OFA) is an emerging alternative that aims to relieve pain using non-opioid medications, reducing these risks and potentially enhancing recovery. Methods: This single-center, prospective, randomized controlled trial included neonates and infants (ASA 1 and 2) undergoing laparoscopic or endoscopic surgeries. Participants randomly received either opioid-based anesthesia (OA) with intravenous fentanyl at induction, followed by continuous infusion or OFA with ketamine at induction, followed by infusion. The primary outcome was postoperative pain, assessed using the Neonatal Infant Pain Scale (NIPS) on admission to the post-anesthesia care unit (PACU). Secondary outcomes included pain scores at intervals up to 12 h postoperatively. Results: NIPS scores were significantly higher in the OFA group in the PACU, with more patients experiencing moderate pain (NIPS >4) in the first hour (41.7%, n = 20 vs. 16.6%, n = 8, respectively; Conclusions: OA with fentanyl offered superior immediate postoperative analgesia compared to OFA with ketamine, while both approaches demonstrated comparable intraoperative stability, recovery profiles, and safety, supporting their use based on clinical needs and patient-specific factors.