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NCT Number: 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

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.

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Key information

Conditions

Follicular Tonsillitis (Chronic) Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fentanyl at 10-15 min before end of surgery

Drug

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)

fentanyl at end of surgery

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 17, 2017
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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