Trial Outcomes & Findings for Fentanyl Test in Children's Adenotonsillectomy (NCT NCT02484222)

Results Overview

Recruitment status

COMPLETED

Target enrollment

80 participants

Primary outcome timeframe

average 1 hour from extubation

Results posted on

2019-07-09

Participant Flow

Children at age of 3 - 7 years with OSAS,The exclusion criteria were craniofacial deformities, mental retardation, BMI \> 22 kg/m², a history of bronchial asthma, and a recent history of opioid use.

Participant milestones

Participant milestones
Measure	The Result of Fentanyl Test The children were divided by the breath decreasing rates-with 50% decreasing rate of breath were positive result, and the rest were negative.
Overall Study STARTED	80
Overall Study COMPLETED	77
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fentanyl Test in Children's Adenotonsillectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	The Result of Fentanyl Test n=80 Participants The children were divided by the breath decreasing rates-with 50% decreasing rate of breath were positive result, and the rest were negative.
Age, Categorical <=18 years	80 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	5.2 years n=99 Participants
Sex: Female, Male Female	65 Participants n=99 Participants
Sex: Female, Male Male	15 Participants n=99 Participants
Region of Enrollment China	80 Participants n=99 Participants

PRIMARY outcome

Timeframe: average 1 hour from extubation

Outcome measures

Outcome measures
Measure	The Result of Fentanyl Test n=77 Participants The children were divided by the breath decreasing rates-with 50% decreasing rate of breath were positive result, and the rest were negative.
Rescue Morphine Requirement	30 mg Interval 20.0 to 40.0

SECONDARY outcome

Timeframe: average 1 hour from extubation

Outcome measures

Outcome measures
Measure	The Result of Fentanyl Test n=77 Participants The children were divided by the breath decreasing rates-with 50% decreasing rate of breath were positive result, and the rest were negative.
Post-operative Nausea and Vomiting	13 Participants

SECONDARY outcome

Timeframe: average 1 hour from extubation

Outcome measures

Outcome measures
Measure	The Result of Fentanyl Test n=77 Participants The children were divided by the breath decreasing rates-with 50% decreasing rate of breath were positive result, and the rest were negative.
Number of Participants With Pulse Oxygen Saturation Less Than 95 Percent	7 Participants

POST_HOC outcome

Timeframe: average 1 hour from extubation

The number of participants who were light consumers of morphine as identified by the Fentanyl Test，we want to know the accurate of the test.The light consumers are the children of who used total morphine \<50 μg/kg.

Outcome measures

Outcome measures
Measure	The Result of Fentanyl Test n=77 Participants The children were divided by the breath decreasing rates-with 50% decreasing rate of breath were positive result, and the rest were negative.
Number of Participants Who Were Light Consumers of Morphine as Identified by the Fentanyl Test	47 Participants

Adverse Events

The Result of Fentanyl Test

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	The Result of Fentanyl Test n=77 participants at risk The children were divided by the breath decreasing rates-with 50% decreasing rate of breath were positive result, and the rest were negative.
General disorders vomiting	16.9% 13/77 • Number of events 13 • 1 hour Post-operative Nausea/vomiting (PONV) and other adverse events, such as airway obstruction, laryngospasm.

Additional Information

Dr.Wang Xuan

the Children's Hospital of Fudan University

Phone: 18017591058

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place