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Completed

NCT Number: NCT01235637

Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction

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.

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Key information

Conditions

Child Comfort Intensive Care Units Morphine Pediatric

Age range

1 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital of Grenoble

Grenoble, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

alfentanil

Drug

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.

Sufentanil

Drug

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.

Primary outcomes

  1. COMFORT score

    Time frame: 8 hours

    pain score recommended in pediatric intensive care units in France

Secondary outcomes

  1. Hemodynamic criteria

    Time frame: 8 hours

    blood pressure and heart rate

  2. Bispectral Index score

    Time frame: 8 hours

    assess the level of child's sedation

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study title

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

Acronym: DOLOREAPEDIA

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 5, 2010
Registry last updated
Jul 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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