Fentanyl Test in Children's Adenotonsillectomy
Fentanyl Test Results and Its Association With Morphine Requirements in Children With Obstructive Sleep Apnea Syndrome After Adenotonsillectomy
1 other identifier
observational
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2015
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2015
CompletedFirst Posted
Study publicly available on registry
June 29, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedResults Posted
Study results publicly available
March 11, 2019
CompletedJuly 9, 2019
June 1, 2019
4 months
June 16, 2015
March 30, 2018
June 29, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rescue Morphine Requirement
average 1 hour from extubation
Secondary Outcomes (2)
Post-operative Nausea and Vomiting
average 1 hour from extubation
Number of Participants With Pulse Oxygen Saturation Less Than 95 Percent
average 1 hour from extubation
Interventions
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.
Eligibility Criteria
children who were diagnosed with Obstructive Sleep Apnea Syndrome(OSAS) by electronic nasopharyngoscope and underwent selective adenotonsillectomy
You may qualify if:
- the American society of anesthesiologists (ASA) class Ⅰ \~ Ⅱ
- the age of 3 \~ 7 years old
- children who underwent selective adenotonsillectomy.
You may not qualify if:
- craniofacial malformations
- mental retardation
- BMI \> 22 kg/m2
- a history of bronchial asthma
- a recent history of opioid use.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chilren's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
Related Publications (1)
Li YH, Wang X, Zhou ZJ, Zhuang PJ. Association between fentanyl test results and rescue morphine requirements in children after adenotonsillectomy. J Anesth. 2018 Feb;32(1):77-81. doi: 10.1007/s00540-017-2433-0. Epub 2017 Nov 21.
PMID: 29164334DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr.Wang Xuan
- Organization
- the Children's Hospital of Fudan University
Study Officials
- PRINCIPAL INVESTIGATOR
Xuan Wang
Children's Hospital of Fudan University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
June 16, 2015
First Posted
June 29, 2015
Study Start
September 1, 2015
Primary Completion
January 1, 2016
Study Completion
January 1, 2016
Last Updated
July 9, 2019
Results First Posted
March 11, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share