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

November 4, 2010
July 3, 2012
June 2010
June 2012   (final data collection date for primary outcome measure)
COMFORT score [ Time Frame: 8 hours ] [ Designated as safety issue: Yes ]
pain score recommended in pediatric intensive care units in France
Same as current
Complete list of historical versions of study NCT01235637 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Child Comfort
  • Morphine
  • Intensive Care Units
  • Pediatric
  • 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.

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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
1 Month to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01235637
DCIC 10 10
Yes
University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
Principal Investigator: Isabelle WROBLEWSKI, MD PHD University Hospital, Grenoble
University Hospital, Grenoble
July 2012

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