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Completed

NCT Number: NCT02484222

Fentanyl Test in Children's Adenotonsillectomy

The purpose of this study is to discuss the relationship between the result of fentanyl test and required dosage of morphine for children with OSAS after adenotonsillectomy；and to evaluate the ability of predicting requested dosage of morphine postoperatively.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chilren's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

All the patients were intubated. Sevoflurane was used for maintenance without any opioids. Before the end of the procedure, spontaneous respiratory was recovered. All the patients were given 1 mcg/kg fentanyl i.v. after the end of the procedure. The positive result was defined as spontaneous respiratory rate decreased more than 50%, the others were defined as negative result. All the patients were given morphine for pain relief according to our protocol after extubation.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

meet all of the following

  • the American society of anesthesiologists (ASA) class Ⅰ ~ Ⅱ
  • the age of 3 ~ 7 years old
  • children who underwent selective adenotonsillectomy.

Exclusion criteria

meet anyone of the following

  • craniofacial malformations
  • mental retardation
  • BMI > 22 kg/m2
  • a history of bronchial asthma
  • a recent history of opioid use.

Treatment and study plan

Fentanyl

Drug

Before the end of the procedure, spontaneous respiratory was recovered. All the patients were given 1 mcg/kg fentanyl i.v. after the end of the procedure.

Other names: Fentanyl test

Primary outcomes

  1. Rescue Morphine Requirement

    Time frame: average 1 hour from extubation

Secondary outcomes

  1. Post-operative Nausea and Vomiting

    Time frame: average 1 hour from extubation

  2. Number of Participants With Pulse Oxygen Saturation Less Than 95 Percent

    Time frame: average 1 hour from extubation

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

Fentanyl Test Results and Its Association With Morphine Requirements in Children With Obstructive Sleep Apnea Syndrome After Adenotonsillectomy

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 29, 2015
Registry last updated
Jul 9, 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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