The REACT Randomized Clinical Trial
Question Does the use of albuterol sulfate (salbutamol sulfate) premedication reduce rates of perioperative respiratory adverse events in children aged 1 to 8 years undergoing anesthesia for tonsillectomy?
Findings In this randomized clinical trial of 479 children, perioperative respiratory adverse events were observed in 67 of 241 of children receiving albuterol and 114 of 238 receiving placebo. Laryngospasm, coughing, and oxygen desaturation each occurred significantly more often in the placebo group.
Meaning The benefits of albuterol premedication should be considered when planning anesthesia for children undergoing tonsillectomy, alongside other strategies for reducing the risk of perioperative respiratory adverse events in this high-risk population.
Importance Tonsillectomy is a common pediatric procedure for the treatment of sleep-disordered breathing and chronic tonsillitis. Up to half of children having this procedure experience a perioperative respiratory adverse event.
Objective To determine whether inhaled albuterol sulfate (salbutamol sulfate) premedication decreases the risk of perioperative respiratory adverse events in children undergoing anesthesia for tonsillectomy.
Design, Setting, and Participants A randomized, triple-blind, placebo-controlled trial (the Reducing Anesthetic Complications in Children Undergoing Tonsillectomies [REACT] trial) was conducted at Perth Children’s Hospital (formerly Princess Margaret Hospital for Children), the only tertiary pediatric hospital in Western Australia. Participants included 484 children aged 0 to 8 years who were undergoing anesthesia for tonsillectomy. The study was conducted between July 15, 2014, and May 18, 2017.
Interventions Participants were randomized to receive either albuterol (2 actuations, 200 μg) or placebo before their surgery.
Main Outcomes and Measures Occurrence of perioperative respiratory adverse events (bronchospasm, laryngospasm, airway obstruction, desaturation, coughing, and stridor) until discharge from the postanesthesia care unit.
Results Of 484 randomized children (median [range] age, 5.6 [1.6-8.9] years; 285 [58.9%] boys), 479 data sets were available for intention-to-treat analysis. Perioperative respiratory adverse events occurred in 67 of 241 children (27.8%) receiving albuterol and 114 of 238 children (47.9%) receiving placebo. After adjusting for age, type of airway device, and severity of obstructive sleep apnea in a binary logistic regression model, the likelihood of perioperative respiratory adverse events remained significantly higher in the placebo group compared with the albuterol group (odds ratio, 2.8; 95% CI, 1.9-4.2; P < .001). Significant differences were seen in children receiving placebo vs albuterol in laryngospasm (28 [11.8%] vs 12 [5.0%]; P = .009), coughing (79 [33.2%] vs 27 [11.2%]; P < .001), and oxygen desaturation (54 [22.7%] vs 36 [14.9%]; P = .03).
Conclusions and Relevance Albuterol premedication administered before tonsillectomy under general anesthesia in young children resulted in a clinically significant reduction in rates of perioperative respiratory adverse events compared with the rates in children who received placebo. Premedication with albuterol should be considered for children undergoing tonsillectomy.