Fentanyl Test in Children's Adenotonsillectomy

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484222
• Other study ID #: FTCA-01
• Status: Completed
• Start date: September 2015
• Est. completion date: January 2016

Study information

• Verified date: June 2019
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 7 Years

Eligibility

Inclusion Criteria:meet all of the following

1. the American society of anesthesiologists (ASA) class ? ~ ?

2. the age of 3 ~ 7 years old

3. children who underwent selective adenotonsillectomy.

Exclusion Criteria:meet anyone of the following

1. craniofacial malformations

2. mental retardation

3. BMI > 22 kg/m2

4. a history of bronchial asthma

5. a recent history of opioid use.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Chilren's Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rescue Morphine Requirement		average 1 hour from extubation
Secondary	Post-operative Nausea and Vomiting		average 1 hour from extubation
Secondary	Number of Participants With Pulse Oxygen Saturation Less Than 95 Percent		average 1 hour from extubation