Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction (DOLOREAPEDIA)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT01235637

First received: November 4, 2010

Last updated: July 3, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 4, 2010

Last Updated Date

July 3, 2012

Start Date ^ICMJE

June 2010

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

COMFORT score [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]

pain score recommended in pediatric intensive care units in France

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01235637 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Hemodynamic criteria [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]
blood pressure and heart rate
Bispectral Index score [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]
assess the level of child's sedation

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction

Official Title ^ICMJE

Efficacy of Alfentanyl Versus Sufentanyl in Children for Pain During Treatment by Tracheal Suction in an Intensive Care Unit.

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Child Comfort
Morphine
Intensive Care Units
Pediatric

Intervention ^ICMJE

Drug: Alfentanil
dosage form: injectable drug, opioid analgesic morphine, intravenous drug.

Dosage: 10μg/Kg, dilution: 1 ml = volume equivalent to 66μg or 10μg/kg = 1.43μg/kg fentanyl.

Frequency and duration: 2 bolus injection before 2 tracheal suctions at 0 and 4 hours respectively.
Drug: Sufentanil
dosage form: injectable drug, opioid analgesic morphine, intravenous drug.

Dosage: intravenous drug to 0,15 µg/Kg : Blisters of 10 ml, box of 20. MERCK

Frequency and duration: 2 bolus injection before 2 tracheal suctions at 0 and 4 hours respectively.

Study Arm (s)

Active Comparator: Alfentanil
Intervention: Drug: Alfentanil
Sham Comparator: Sufentanil
Intervention: Drug: Sufentanil

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2012

Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

1 Month to 15 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01235637

Other Study ID Numbers ^ICMJE

DCIC 10 10

Has Data Monitoring Committee

Yes

Responsible Party

University Hospital, Grenoble

Study Sponsor ^ICMJE

University Hospital, Grenoble

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Isabelle WROBLEWSKI, MD PHD

University Hospital, Grenoble

Information Provided By

University Hospital, Grenoble

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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