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Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy

Primary Purpose

Tonsillar Hypertrophy

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tulobuterol Hydrochloride
Placebo transdermal patch
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tonsillar Hypertrophy

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital
  • Hyun-Joo Kim
  • Jin-Kyung Kim
  • Chung-Ang University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tulobuterol patch

Placebo

Arm Description

Outcomes

Primary Outcome Measures

perioperative respiratory complication
laryngospasm, bronchospasm, oxygen desaturation, airway obstruction, severe coughing, postoperative stridor

Secondary Outcome Measures

Full Information

First Posted
August 12, 2019
Last Updated
December 29, 2021
Sponsor
Seoul National University Hospital
Collaborators
Samsung Medical Center, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04057469
Brief Title
Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy
Official Title
Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
December 20, 2019 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Samsung Medical Center, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillar Hypertrophy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tulobuterol patch
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tulobuterol Hydrochloride
Intervention Description
The appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours.
Intervention Type
Drug
Intervention Name(s)
Placebo transdermal patch
Intervention Description
The appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours.
Primary Outcome Measure Information:
Title
perioperative respiratory complication
Description
laryngospasm, bronchospasm, oxygen desaturation, airway obstruction, severe coughing, postoperative stridor
Time Frame
from anesthetic induction to postanesthesia care unit discharge, an average of 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Hyun-Joo Kim
City
Seoul
ZIP/Postal Code
03721
Country
Korea, Republic of
Facility Name
Jin-Kyung Kim
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
ZIP/Postal Code
06973
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy

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