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Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy

NCT04057469 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2022-01-14

No results posted yet for this study

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.

Conditions

  • Tonsillar Hypertrophy

Interventions

DRUG

Tulobuterol Hydrochloride

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

DRUG

Placebo transdermal patch

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

Sponsors & Collaborators

  • Samsung Medical Center

    collaborator OTHER

  • Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    collaborator OTHER

  • Severance Hospital

    collaborator OTHER

  • Seoul National University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04057469 on ClinicalTrials.gov