drugset / Trial / NCT04057469

Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy

NCT04057469 ↗

RandomizedParallel-groupQuadruple-blindPrevention

Summary

* 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. * We tried to determine whether tulobuterol patch (transdermal bronchodilator) premedication decreases the risk of perioperative respiratory adverse events in children undergoing anesthesia for tonsillectomy.

Timeline

Start
2019-12-20
Primary completion
2021-09-30
Completion
2021-09-30

Outcome

Met primary endpoint

paper The incidence of any perioperative respiratory adverse event was lower with tulobuterol (n = 13/88; 14.7%) than that with the placebo (n = 40/94; 42.5%), PMID 36727868 ↗

paper with an estimated average relative risk (95% confidence interval) across components of 0.35 (0.20-0.60; P < .001). PMID 36727868 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Tulobuterol Small molecule 1 mg Other

Indications

No indication recorded.