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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alfentanil | Active Comparator |
| |
| Sufentanil | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| COMFORT score | pain score recommended in pediatric intensive care units in France | 8 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle WROBLEWSKI, MD PHD | University Hospital, Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Grenoble | Grenoble | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11432213 | Background | Stanik-Hutt JA, Soeken KL, Belcher AE, Fontaine DK, Gift AG. Pain experiences of traumatically injured patients in a critical care setting. Am J Crit Care. 2001 Jul;10(4):252-9. | |
| 15636661 | Background | Ista E, van Dijk M, Tibboel D, de Hoog M. Assessment of sedation levels in pediatric intensive care patients can be improved by using the COMFORT "behavior" scale. Pediatr Crit Care Med. 2005 Jan;6(1):58-63. doi: 10.1097/01.PCC.0000149318.40279.1A. |
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| ID | Term |
|---|---|
| D015760 | Alfentanil |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| 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. |
|
| 15693968 | Background | Triltsch AE, Nestmann G, Orawa H, Moshirzadeh M, Sander M, Grosse J, Genahr A, Konertz W, Spies CD. Bispectral index versus COMFORT score to determine the level of sedation in paediatric intensive care unit patients: a prospective study. Crit Care. 2005 Feb;9(1):R9-17. doi: 10.1186/cc2977. Epub 2004 Nov 10. |
| 11907667 | Background | Brocas E, Dupont H, Paugam-Burtz C, Servin F, Mantz J, Desmonts JM. Bispectral index variations during tracheal suction in mechanically ventilated critically ill patients: effect of an alfentanil bolus. Intensive Care Med. 2002 Feb;28(2):211-3. doi: 10.1007/s00134-001-1189-y. Epub 2002 Jan 12. |
| 16697580 | Background | Veyckemans F. [Sedation in children: how and for who?]. Arch Pediatr. 2006 Jun;13(6):835-7. doi: 10.1016/j.arcped.2006.03.131. Epub 2006 May 12. No abstract available. French. |