Fentanyl Test in Children's Adenotonsillectomy

NCT ID: NCT02484222

Last Updated: 2019-07-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Fentanyl

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.

Intervention Type DRUG

Other Intervention Names

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Fentanyl test

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. craniofacial malformations
2. mental retardation
3. BMI \> 22 kg/m2
4. a history of bronchial asthma
5. a recent history of opioid use.
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Xuan Wang

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xuan Wang

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital of Fudan University

Locations

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Chilren's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 29164334 (View on PubMed)

Other Identifiers

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FTCA-01

Identifier Type: -

Identifier Source: org_study_id

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