Flexible laryngeal mask airway versus endotracheal tube in pediatric tonsillectomy and adenoidectomy: a randomized controlled trial

Tonsillectomy and adenoidectomy (T&A) are common paediatric surgeries traditionally performed under general anaesthesia with endotracheal intubation (ETT). Although effective, ETT is associated with airway irritation and haemodynamic stress responses. The flexible laryngeal mask airway (FLMA) is a potential supraglottic alternative, but comparative evidence in this setting remains limited. This randomised controlled trial compared FLMA and ETT in children. This phase II double-blinded, randomised controlled trial was conducted in children aged 2–10 years with ASA physical status I-II, scheduled for elective T&A. Participants who were randomly assigned to either the FLMA ( Ambu® AuraFlex™, Ambu A/S, Denmark) or ETT (WELLLEAD MEDICAL CO, LTD. China) group. The primary outcomes were the rate of successful placement, wake-up time and extubation time. Secondary outcomes included perioperative heart rate (HR) and mean arterial pressure (MAP), anaesthetic use, operation time, surgeon satisfaction, and adverse events. Of 116 children assessed, 103 were randomised (FLMA, n = 51; ETT, n = 52). Baseline characteristics were balanced between groups. Airway placement was successful in all patients, with no significant between-group difference in insertion attempts. The FLMA group had significantly shorter wake-up time (median: 15.0 vs. 19.5 min; P = 0.006) and extubation time (mean: 11.9 vs. 14.8 min; P < 0.001). Surgeon satisfaction was lower in the FLMA group (median: 90 vs. 100; P < 0.001). Haemodynamic responses were more stable with FLMA, whereas ETT was associated with marked increases in HR and MAP immediately after intubation. Postoperative adverse events were significantly fewer in the FLMA group than in the ETT group (11.8% [95% CI 4.5–23.9%] vs. 30.8% [95% CI 18.9–44.5%]; P = 0.02). No hypoxia or laryngospasm occurred with FLMA, whereas each occurred in 5.8% of ETT-group children. Intraoperative adverse events did not differ between groups. In children undergoing elective T&A, FLMA provided faster emergence from anaesthesia, more stable haemodynamics, and fewer postoperative adverse events compared with ETT, supporting its use as a safe and effective alternative. The lower surgeon satisfaction observed suggests a need for device-specific training or technical refinements to optimise surgical field exposure. Trial registration : The trial was retrospectively registered at ClinicalTrials.gov (NCT06356298, 04/04/2024).