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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04057469
Other study ID # 1905-178-103
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 20, 2019
Est. completion date September 30, 2021

Study information

Verified date December 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 182
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 3 Years to 6 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tulobuterol Hydrochloride
The appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours.
Placebo transdermal patch
The appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours.

Locations

Country Name City State
Korea, Republic of Chung-Ang University Hospital Seoul
Korea, Republic of Hyun-Joo Kim Seoul
Korea, Republic of Jin-Kyung Kim Seoul
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (4)

Lead Sponsor Collaborator
Seoul National University Hospital Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Samsung Medical Center, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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