Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-20

Study Completion Date

2021-09-30

Brief Summary

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* 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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Detailed Description

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Conditions

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Tonsillar Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tulobuterol patch

Group Type EXPERIMENTAL

Tulobuterol Hydrochloride

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo transdermal patch

Intervention Type DRUG

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

Interventions

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Tulobuterol Hydrochloride

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

Intervention Type DRUG

Placebo transdermal patch

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No