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
About this trial
This is an interventional prevention trial for Tonsillar Hypertrophy
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
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
NCT ID
NCT04057469
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
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
Learn more about this trial
Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy
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