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Clinical Trials/NCT02484222
NCT02484222CompletedNot Applicable

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

Children's Hospital of Fudan University1 site in 1 country80 target enrollmentStarted: September 2015Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
80
Locations
1
Primary Endpoint
Rescue Morphine Requirement

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
3 Years to 7 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Rescue Morphine Requirement

Time Frame: average 1 hour from extubation

Secondary Outcomes

  • Number of Participants With Pulse Oxygen Saturation Less Than 95 Percent(average 1 hour from extubation)
  • Post-operative Nausea and Vomiting(average 1 hour from extubation)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Xuan Wang

Doctor

Children's Hospital of Fudan University

Study Sites (1)

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