Effect of Albuterol Premedication vs Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: The REACT Randomized Clinical Trial

Abstract

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.

Trial registration: Australian New Zealand Clinical Trials Registry identifier: ACTRN12614000739617.

Conflict of interest statement

Conflict of Interest Disclosures: Dr von Ungern-Sternberg reported receiving grants from the Perth Children’s Hospital (PCH) Foundation and Australia and New Zealand College of Anaesthetists (ANZCA), and other support from the PCH Foundation during the conduct of the study. Dr Sommerfield reported receiving grants from the PCH Foundation and from Australian and New Zealand College of Anaesthetists during the conduct of the study. Ms Slevin reported receiving grants from the PCH Foundation and ANZCA during the conduct of the study. No other disclosures were reported.

Figures

Figure.. Clinical Trial Profile

Inclusion criteria: elective tonsillectomy with or without adenoidectomy, grommets, cautery of inferior turbinates, or examination of the ear under general anesthesia with use of laryngeal mask airway (ages 3-8 years) or endotracheal tubes (ages 0-6 years). Exclusion criteria: known cardiopulmonary disease (main criterion) (uncorrected congenital heart disease, primary or secondary pulmonary hypertension, tumors, structural lung diseases), use of sedation medication (midazolam, clonidine), and known difficult airway or thoracic malformation.