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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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ClinicalTrials.gov Identifier: NCT03343002
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : July 11, 2018
Sponsor:
Information provided by (Responsible Party):
Yonsei University

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.

Condition or disease Intervention/treatment Phase
Follicular Tonsillitis (Chronic) Drug: fentanyl at 10-15 min before end of surgery Drug: fentanyl at end of surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : November 15, 2017
Estimated Primary Completion Date : October 22, 2019
Estimated Study Completion Date : October 22, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: fentanyl at 10-15 min before end of surgery Drug: fentanyl at 10-15 min before end of surgery
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)

Active Comparator: fentanyl at end of surgery Drug: fentanyl at end of surgery
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 Measures :
  1. Incidence of postoperative nausea and vomiting [ Time Frame: In 10-minute increments from immediately(less than 3 min) after entering PACU to departure ]
    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 :
  1. 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. [ Time Frame: In 10-minute increments from immediately(less than 3 min) after entering PACU to departure ]
    *Pediatric Anesthesia Emergence Delirium scale: range 0-20 points. If the score is more than 12, it is considered to be EA occurrence.

  2. 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. [ Time Frame: In 10-minute increments from immediately(less than 3 min) after entering PACU to departure ]
    *five-step Emergence Agitation scale: range 1-5 score. If the score is 4 or more, it is regarded as EA occurrence.

  3. 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 ]
  4. anesthesia recovery time [ Time Frame: up to 1 day after end of surgery ]
    <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

  5. Occurrence of side effect [ Time Frame: In 10-minute increments from immediately(less than 3 min) after entering PACU to departure ]
    airway obstruction, laryngospasm, desaturation, drowsiness, pruritus, hypotension, bradycardia



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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343002


Contacts
Contact: Hyun Joo Kim, MD 82-2-2227-0470 JJOLLONG@yuhs.ac

Locations
Korea, Republic of
Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Hyun Joo Kim, MD    + 82-2-2227-0470    jjollong@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03343002     History of Changes
Other Study ID Numbers: 4-2017-0813
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Tonsillitis
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nausea
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics