Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction
NCT ID: NCT01235637
Last Updated: 2012-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
40 participants
INTERVENTIONAL
2010-06-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Alfentanil
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.
Sufentanil
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Month
15 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Isabelle WROBLEWSKI, MD PHD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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University Hospital of Grenoble
Grenoble, , France
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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DCIC 10 10
Identifier Type: -
Identifier Source: org_study_id