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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

Primary Purpose

Follicular Tonsillitis (Chronic)

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
fentanyl at 10-15 min before end of surgery
fentanyl at end of surgery
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Follicular Tonsillitis (Chronic)

Eligibility Criteria

3 Years - 7 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

fentanyl at 10-15 min before end of surgery

fentanyl at end of surgery

Arm Description

Outcomes

Primary Outcome Measures

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"

Secondary Outcome Measures

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.
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.
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.
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
Occurrence of side effect
airway obstruction, laryngospasm, desaturation, drowsiness, pruritus, hypotension, bradycardia

Full Information

First Posted
October 23, 2017
Last Updated
August 6, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03343002
Brief 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
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 26, 2017 (Actual)
Primary Completion Date
August 27, 2018 (Actual)
Study Completion Date
August 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Follicular Tonsillitis (Chronic)

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fentanyl at 10-15 min before end of surgery
Arm Type
Experimental
Arm Title
fentanyl at end of surgery
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
fentanyl at 10-15 min before end of surgery
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
fentanyl at end of surgery
Intervention Description
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)
Primary Outcome Measure Information:
Title
Incidence of postoperative nausea and vomiting
Description
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"
Time Frame
In 10-minute increments from immediately(less than 3 min) after entering PACU to departure
Secondary Outcome Measure Information:
Title
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.
Description
*Pediatric Anesthesia Emergence Delirium scale: range 0-20 points. If the score is more than 12, it is considered to be EA occurrence.
Time Frame
In 10-minute increments from immediately(less than 3 min) after entering PACU to departure
Title
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.
Description
*five-step Emergence Agitation scale: range 1-5 score. If the score is 4 or more, it is regarded as EA occurrence.
Time Frame
In 10-minute increments from immediately(less than 3 min) after entering PACU to departure
Title
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.
Time Frame
In 10-minute increments from immediately after entering PACU to departure
Title
anesthesia recovery time
Description
<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
Time Frame
up to 1 day after end of surgery
Title
Occurrence of side effect
Description
airway obstruction, laryngospasm, desaturation, drowsiness, pruritus, hypotension, bradycardia
Time Frame
In 10-minute increments from immediately(less than 3 min) after entering PACU to departure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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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

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