Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction

Phase 3

Completed

• Conditions: Morphine; Intensive Care Units; Pediatric; Child Comfort
• Interventions: Drug: Sufentanil; Drug: Alfentanil

• Registration Number: NCT01235637
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

The main objective is to assess the efficacy of Alfentanil for pain in children treated by tracheal suction in pediatric intensive care units in France, compared to Sufentanyl, the current standard treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-11-04
• Study First Submitted QC: 2010-11-04
• Study First Posted: 2010-11-05
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-03
• Last Update Posted: 2012-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• child between 1 month and 15 years of age
• affiliation to the French social security system or equivalent
• child receiving mechanical ventilation for at least 4 hours and less than 48 hours
• ventilation to be provided for at least 8 hours
• less than 30 days in pediatric intensive care
• child under intravenous sedation
• consent of both parents
• consent of child when possible

Exclusion Criteria

• curarized child
• ketamine treatment
• children suffering from facial and/or severe brain traumatism
• known hypersensitivity reaction to morphine or intolerance insufficiency to sufentanyl
• respiratory
• chronic obstructive pulmonary disease
• myasthenia
• treatment with morphine agonists-antagonists, or combination with MAOIs
• renal or liver disorders
• preterm birth of more than one month of life (but not at full term by corrected age)
• associated treatment or pathology contra-indicating administration of Sufentanyl epidural

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sufentanil	Sufentanil	-
Alfentanil	Alfentanil	-

Primary Outcome Measures

Name	Time	Method
COMFORT score	8 hours	pain score recommended in pediatric intensive care units in France

Secondary Outcome Measures

Name	Time	Method
Hemodynamic criteria	8 hours	blood pressure and heart rate
Bispectral Index score	8 hours	assess the level of child's sedation

Trial Locations

Locations (1)

University Hospital of Grenoble; 🇫🇷 Grenoble, France