Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy
Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies
1 other identifier
interventional
182
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2019
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2019
CompletedFirst Posted
Study publicly available on registry
August 15, 2019
CompletedStudy Start
First participant enrolled
December 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2021
CompletedJanuary 14, 2022
December 1, 2021
1.8 years
August 12, 2019
December 29, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
perioperative respiratory complication
laryngospasm, bronchospasm, oxygen desaturation, airway obstruction, severe coughing, postoperative stridor
from anesthetic induction to postanesthesia care unit discharge, an average of 3 hours
Study Arms (2)
Tulobuterol patch
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
The appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours.
The appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours.
Eligibility Criteria
You may qualify if:
- pediatric patients undergoing tonsillectomy
You may not qualify if:
- recent upper respiratory infection (2weeks)
- Allergy to tulobuterol patch
- Patients receiving catecholamine (epinephrine, isoproterenol)
- hyperthyroidism
- hypertension
- cardiac disease
- Diabetes melitus
- atopic dermatitis
- Asthma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Samsung Medical Centercollaborator
- Chung-Ang University Hosptial, Chung-Ang University College of Medicinecollaborator
- Severance Hospitalcollaborator
Study Sites (4)
Seoul National University Hospital
Seoul, 03080, South Korea
Hyun-Joo Kim
Seoul, 03721, South Korea
Jin-Kyung Kim
Seoul, 06351, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
Related Publications (1)
Kim EH, Lee SH, Kim JK, Park YH, Kang P, Park JB, Ji SH, Jang YE, Lee JH, Kim JT, Kim HS. Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies: A Randomized Controlled Trial. Anesth Analg. 2023 Jun 1;136(6):1067-1074. doi: 10.1213/ANE.0000000000006355. Epub 2023 May 19.
PMID: 36727868DERIVED
MeSH Terms
Interventions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor
Study Record Dates
First Submitted
August 12, 2019
First Posted
August 15, 2019
Study Start
December 20, 2019
Primary Completion
September 30, 2021
Study Completion
September 30, 2021
Last Updated
January 14, 2022
Record last verified: 2021-12