Britta S von Ungern-Sternberg1,2,3, David Sommerfield1,2, Lliana Slevin1,3, Thomas F E Drake-Brockman1,2, Guicheng Zhang4,5,6, Graham L Hall3,7,8. 1. Department of Anaesthesia and Pain Management, Perth Children's Hospital, Perth, Australia. 2. Division of Anaesthesiology, Medical School, The University of Western Australia, Perth, Australia. 3. Telethon Kids Institute, Perth, Australia. 4. School of Public Health, Curtin University, Perth, Australia. 5. Centre for Genetic Origins of Health and Disease, Curtin University, Perth, Australia. 6. University of Western Australia, Perth, Australia. 7. School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia. 8. Centre for Child Health Research, University of Western Australia, Perth, Australia.
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 ChildrenUndergoing 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.
RCT Entities:
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.
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Authors: Walid Habre; Nicola Disma; Katalin Virag; Karin Becke; Tom G Hansen; Martin Jöhr; Brigitte Leva; Neil S Morton; Petronella M Vermeulen; Marzena Zielinska; Krisztina Boda; Francis Veyckemans Journal: Lancet Respir Med Date: 2017-03-28 Impact factor: 30.700
Authors: Anoop Ramgolam; Graham L Hall; Guicheng Zhang; Mary Hegarty; Britta S von Ungern-Sternberg Journal: Anesthesiology Date: 2018-06 Impact factor: 7.892
Authors: Thomas F E Drake-Brockman; Anoop Ramgolam; Guicheng Zhang; Graham L Hall; Britta S von Ungern-Sternberg Journal: Lancet Date: 2017-01-18 Impact factor: 79.321
Authors: A Ramgolam; G L Hall; D Sommerfield; L Slevin; T F E Drake-Brockman; G Zhang; B S von Ungern-Sternberg Journal: Br J Anaesth Date: 2017-07-01 Impact factor: 9.166