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Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy

Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04057469
Enrollment
182
Registered
2019-08-15
Start date
2019-12-20
Completion date
2021-09-30
Last updated
2022-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tonsillar Hypertrophy

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.

Interventions

DRUGTulobuterol Hydrochloride

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.

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
3 Years to 6 Years
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

Design outcomes

Primary

MeasureTime frameDescription
perioperative respiratory complicationfrom anesthetic induction to postanesthesia care unit discharge, an average of 3 hourslaryngospasm, bronchospasm, oxygen desaturation, airway obstruction, severe coughing, postoperative stridor

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026