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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Follicular Tonsillitis (Chronic)

Intervention / Treatment
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* Drug: fentanyl at 10-15 min before end of surgery
* Drug: fentanyl at end of surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fentanyl at 10-15 min before end of surgery<br> | Drug: fentanyl at 10-15 min before end of surgery<br>* Label 2 syringe is filled with 1mcg/kg of fentanyl, label 1 syringe is filled with same amount of saline solution. If the surgeon notifies the anesthesiologist 10-15 minutes before the end of the operation, the syringe drug labeled 1 will be administered intravenously(that is, normal saline ). At the end of the surgery, the syringe drug labeled 2 is administered intravenously((that is, 1mcg/kg of fentanyl)<br>|
| Active Comparator: fentanyl at end of surgery<br> | Drug: fentanyl at end of surgery<br>* Label 2 syringe is filled with 1mcg/kg of fentanyl, label 1 syringe is filled with same amount of saline solution. If the surgeon notifies the anesthesiologist 10-15 minutes before the end of the operation, the syringe drug labeled 1 will be administered intravenously(that is, normal saline ). At the end of the surgery, the syringe drug labeled 2 is administered intravenously((that is, 1mcg/kg of fentanyl)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative nausea and vomiting | Occurrence of nausea and vomiting- Described as yes/no (Observation of medical personnel or Subjective symptoms of the patient by the definition below) Nausea: feeling of the urge to vomit vomiting: retching and any expulsion of liquid gastric contents | In 10-minute increments from immediately(less than 3 min) after entering PACU to departure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | *Pediatric Anesthesia Emergence Delirium scale: range 0-20 points. If the score is more than 12, it is considered to be EA occurrence. | In 10-minute increments from immediately(less than 3 min) after entering PACU to departure | 
| 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. | *five-step Emergence Agitation scale: range 1-5 score. If the score is 4 or more, it is regarded as EA occurrence. | In 10-minute increments from immediately(less than 3 min) after entering PACU to departure | 
| 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. |  | In 10-minute increments from immediately after entering PACU to departure | 
| anesthesia recovery time | <1> time until regular respiration is possible after end of surgery , <2>time to extubate after end of surgery, and <3>eye opening time in response to initial verbal command after end of surgery | up to 1 day after end of surgery | 
| Occurrence of side effect | airway obstruction, laryngospasm, desaturation, drowsiness, pruritus, hypotension, bradycardia | In 10-minute increments from immediately(less than 3 min) after entering PACU to departure |