Tulobuterol Patch in Pediatric Patients Undergoing Tonsillectomy

Seoul National University

Status: Completed

Conditions: Tonsillar Hypertrophy

Treatments: Drug: Placebo transdermal patch; Drug: Tulobuterol Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04057469

1905-178-103

Details and patient eligibility

About

• 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.

Enrollment: 182 patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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182 participants in 2 patient groups, including a placebo group

Tulobuterol patch

Experimental group

Treatment:

Drug: Tulobuterol Hydrochloride

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo transdermal patch