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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01235637

Acronym

DOLOREAPEDIA

Enrollment

Registered

2010-11-05

Start date

2010-06-30

Completion date

2012-06-30

Last updated

2012-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Child Comfort, Intensive Care Units, Morphine, Pediatric

Keywords

COMFORT B score, Bis score

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.

Interventions

DRUGAlfentanil

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.

DRUGSufentanil

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Months to 15 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
COMFORT score	8 hours	pain score recommended in pediatric intensive care units in France

Secondary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026