Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies
A Randomized Controlled Trial
August 2023 by Dr J Houghton
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.
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
- Recent RTI within 2 weeks
- History of allergic reaction or side effect to tulobuterol patch
- Thyrotoxicosis/hypertension/diabetes/atopic dermatitis/asthma
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.
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.
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
- Severe coughing
- Postoperative stridor
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.
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.