Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy

* 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.

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Key information

Conditions

Tonsillar Hypertrophy

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chung-Ang University Hospital, Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

pediatric patients undergoing tonsillectomy

Exclusion criteria

recent upper respiratory infection (2weeks)
Allergy to tulobuterol patch
Patients receiving catecholamine (epinephrine, isoproterenol)
hyperthyroidism
hypertension
cardiac disease
Diabetes melitus
atopic dermatitis
Asthma

Treatment and study plan

Tulobuterol Hydrochloride

Drug

The appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours.

Placebo transdermal patch

Drug

The appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours.

Primary outcomes

perioperative respiratory complication

Time frame: from anesthetic induction to postanesthesia care unit discharge, an average of 3 hours

laryngospasm, bronchospasm, oxygen desaturation, airway obstruction, severe coughing, postoperative stridor

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

Chung-Ang University Hospital
Samsung Medical Center
Severance Hospital

Registry information

Official study title

Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies

Important dates

Study start: 2019
Primary completion: 2021
Study completion: 2021
First posted: Aug 15, 2019
Registry last updated: Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed