Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction

Study Overview
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Brief Summary
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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.

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

Conditions
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Child Comfort, Morphine, Intensive Care Units, Pediatric

Intervention / Treatment
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* Drug: Alfentanil
* Drug: Sufentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alfentanil<br> | Drug: Alfentanil<br>* 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.<br>|
| Sham Comparator: Sufentanil<br> | Drug: Sufentanil<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COMFORT B score, Bis score