Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies
A Randomized Controlled Trial
Anesthesia Analgesia
Submitted August 2023 by Dr J Houghton
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Hypothesis: Inhaled B-2 agonists have proven benefits in reducing the incidence of paediatric perioperative respiratory adverse events (PRAE). Therefore, transdermal tulobuterol (peak effect 9-12 hours post application with 24-hour efficacy) should decrease the incidence of perioperative adverse respiratory events when compared to placebo.
Design: Prospective, multi-centre, triple blinded, randomised control trial undertaken at 3 tertiary paediatric centres in Seoul, Korea. 188 patients enrolled; age 3-6 years having scheduled elective tonsillectomy - Sample size based based on PRAE incidence in tonsillectomy both with/without inhaled B2 agonist Exclusions were. - Recent RTI within 2 weeks - History of allergic reaction or side effect to tulobuterol patch - Thyrotoxicosis/hypertension/diabetes/atopic dermatitis/asthma
Intervention: Patch or placebo applied by parents 8-10 hour pre planned surgery. Compliance and side effects assessed pre induction. IV induction with fentanyl/propofol and subsequent muscle relaxation with rocuronium. Sevoflurane maintenance. Dexamethasone/Ondansetron and PRN fentanyl at discretion of anaesthetist. Neostigmine/atropine reversal with extubation occurring when patient awake, train of four ratio > 90% and adequate tidal volume.
Outcome: Primary outcome was any PRAE from induction to discharge from PACU
For this study PRAE assessed by a blinded anaesthetist and defined as - Desaturation < 95% - Airway obstruction – obstruction combined with snoring noise/respiratory effort - Laryngospasm - Bronchospasm - Severe coughing - Postoperative stridor
Results: 88 in tulobuterol group and 94 in placebo group; from similar demographics Overall incidence of PRAE: - Tulobuterol 14.7% vs42.5% - Relative risk (95%CI) 0.31 (0.17-0.56 p < 0.014)
Of all the assessed PRAE the difference between control and placebo was in airway obstruction and severe cough. There was no difference in the incidence of desaturation/laryngospasm/bronchospasm or stridor between groups.
Summary In a group of well 3-6 year olds having elective tonsillectomy the application of a tulobuterol patch 8-10 hours prior to scheduled surgery reduced the incidence of airway obstruction and severe cough when compared with placebo.
There was no difference in the incidence desaturation/laryngospasm/bronchospasm or stridor.
