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

July 3, 2012 updated by: University Hospital, Grenoble

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France
        • University hospital of Grenoble

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Alfentanil
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.
Sham Comparator: Sufentanil
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COMFORT score
Time Frame: 8 hours
pain score recommended in pediatric intensive care units in France
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemodynamic criteria
Time Frame: 8 hours
blood pressure and heart rate
8 hours
Bispectral Index score
Time Frame: 8 hours
assess the level of child's sedation
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Investigators

  • Principal Investigator: Isabelle WROBLEWSKI, MD PHD, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 4, 2010

First Submitted That Met QC Criteria

November 4, 2010

First Posted (Estimate)

November 5, 2010

Study Record Updates

Last Update Posted (Estimate)

July 4, 2012

Last Update Submitted That Met QC Criteria

July 3, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DCIC 10 10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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