Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy

Tonsillar Hypertrophy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04057469
• Other study ID #: 1905-178-103
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hypertrophy
• Tonsillar Hypertrophy

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