Clinical trial NCT03343002: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Follicular Tonsillitis (Chronic)
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 140
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting
timeFrame: In 10-minute increments from immediately(less than 3 min) after entering PACU to departure
Secondary outcomes:
measure: PAED scale score: *Pediatric Anesthesia Emergence Delirium scale: range 0-20 points. If the score is more than 12, it is considered to be EA occurrence.
timeFrame: In 10-minute increments from immediately(less than 3 min) after entering PACU to departure
measure: five-step EA scale: *five-step Emergence Agitation scale: range 1-5 score. If the score is 4 or more, it is regarded as EA occurrence.
timeFrame: In 10-minute increments from immediately(less than 3 min) after entering PACU to departure
measure: FLACC score FLACC score (Face, Legs, Activity, Cry, Consolability scale): range 0-10. If the score is 4 or more, Pain control is considered necessary.
timeFrame: In 10-minute increments from immediately after entering PACU to departure
measure: anesthesia recovery time
timeFrame: up to 1 day after end of surgery
measure: Occurrence of side effect
timeFrame: In 10-minute increments from immediately(less than 3 min) after entering PACU to departure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
Study officials:
References: