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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
  Purpose

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.


Condition Intervention Phase
Child Comfort
Morphine
Intensive Care Units
Pediatric
 Drug: Alfentanil
Drug: Sufentanil
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Alfentanyl Versus Sufentanyl in Children for Pain During Treatment by Tracheal Suction in an Intensive Care Unit.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • COMFORT score [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]
    pain score recommended in pediatric intensive care units in France


Secondary Outcome Measures:
  • 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


Enrollment: 40
Study Start Date: June 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   1 Month to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01235637

Locations
France
University Hospital of Grenoble
Grenoble, France
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Isabelle WROBLEWSKI, MD PHD University Hospital, Grenoble
  More Information

Publications:

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01235637     History of Changes
Other Study ID Numbers: DCIC 10 10
Study First Received: November 4, 2010
Last Updated: July 3, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
COMFORT B score
Bis score

Additional relevant MeSH terms:
Alfentanil
Sufentanil
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on May 16, 2013