Effect of Intravenous Fentanyl on the Occurrence of Postoperative Nausea and Vomiting According to Time of Administration Around the End of Tonsillectomy With or Without Adenoidectomy

Yonsei University

Status: Completed

Conditions: Follicular Tonsillitis (Chronic)

Treatments: Drug: fentanyl at 10-15 min before end of surgery; Drug: fentanyl at end of surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03343002

4-2017-0813

Details and patient eligibility

About

Fentanyl is a commonly used drug for the prevention of emergence agitation and reduction in postoperative pain in children receiving tonsillectomy. However, fentanyl can cause postoperative nausea and vomiting (PONV), which is a main target side effect that medical staff strives to prevent. However, recent meta-analysis showed that the incidence of PONV may be different depending on the time of administration of fentanyl. However, the research design of patients enrolled in each study, such as the age, the name of the operation, and the method of anesthesia, is not identical. The aim of this study was to evaluate the efficacy and safety of fentanyl in patients undergoing tonsillectomy with a prospective randomized controlled trial. Secondary outcomes include incidence and severity of emergence agitation and anesthesia recovery time, postanesthesia care unit (PACU) time, side effects.

Enrollment: 140 patients

Sex: All

Ages: 3 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pediatric patients aged 3 to 7 years with ASA 1-II scheduled for tonsillectomy (or adenoidal tonsillectomy)

Exclusion criteria

• 1. History of developmental disorder, cognitive impairment, cerebral palsy
• 2. History of seizures(not simple febrile convulsions)
• 3. Upper respiratory infections
• 4. Structural airway disease predicting difficult airway
• 5. History of an adverse reaction, including allergic reactions to fentanyl

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups

fentanyl at 10-15 min before end of surgery

Experimental group

Treatment:

Drug: fentanyl at 10-15 min before end of surgery

fentanyl at end of surgery

Active Comparator group

Treatment:

Drug: fentanyl at end of surgery