Tonsillar Hypertrophy Clinical Trial
Official title:
Effect of Tulobuterol Patch Versus Placebo on the Occurrence of Respiratory Adverse Events in Children Undergoing Tonsillectomies
Verified date | December 2021 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
- 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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital | Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Samsung Medical Center, Severance Hospital |
Korea, Republic of,
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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