Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04057469
• Collaborator: Samsung Medical Center (Other), Chung-Ang University Hosptial, Chung-Ang University College of Medicine (Other), Severance Hospital (Other)
• Enrollment: 182
• Locations: 4
• Arms: 2
• Actual Duration (Months): 21.4
• Patients Per Site: 45.5
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Tonsillar Hypertrophy	Drug: Tulobuterol Hydrochloride; Drug: Placebo transdermal patch	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 182 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies
• Actual Study Start Date: Dec 20, 2019
• Actual Primary Completion Date: Sep 30, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tulobuterol patch	Drug: Tulobuterol Hydrochloride; The appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours.
Placebo Comparator: Placebo	Drug: Placebo transdermal patch; The appropriate time interval between the patch attachment and the end of surgery was within 8 to 10 hours.

Outcome Measures

Primary Outcome Measures

1. perioperative respiratory complication [from anesthetic induction to postanesthesia care unit discharge, an average of 3 hours]

   laryngospasm, bronchospasm, oxygen desaturation, airway obstruction, severe coughing, postoperative stridor

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	03080
2	Hyun-Joo Kim	Seoul		Korea, Republic of	03721
3	Jin-Kyung Kim	Seoul		Korea, Republic of	06351
4	Chung-Ang University Hospital	Seoul		Korea, Republic of	06973

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hee-Soo Kim, professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT04057469
• Other Study ID Numbers: 1905-178-103
• First Posted: Aug 15, 2019
• Last Update Posted: Jan 14, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertrophy; Tulobuterol

Study Results

No Results Posted as of Jan 14, 2022