Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction
Information source: University Hospital, Grenoble
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Child Comfort; Morphine; Intensive Care Units; Pediatric
Intervention: Alfentanil (Drug); Sufentanil (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: University Hospital, Grenoble Official(s) and/or principal investigator(s): Isabelle WROBLEWSKI, MD PHD, Principal Investigator, Affiliation: University Hospital, Grenoble
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.
Clinical Details
Official title: Efficacy of Alfentanyl Versus Sufentanyl in Children for Pain During Treatment by Tracheal Suction in an Intensive Care Unit.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: COMFORT score
Secondary outcome: Hemodynamic criteriaBispectral Index score
Eligibility
Minimum age: 1 Month.
Maximum age: 15 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
University Hospital of Grenoble, Grenoble, France
Additional Information
Related publications: 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. Triltsch AE, Nestmann G, Orawa H, Moshirzadeh M, Sander M, Grosse J, Genähr 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. Epub 2004 Nov 10. Erratum in: Crit Care. 2005 Oct 5;9(5):426. 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. Epub 2002 Jan 12. Veyckemans F. [Sedation in children: how and for who?]. Arch Pediatr. 2006 Jun;13(6):835-7. Epub 2006 May 12. French.
Starting date: June 2010
Last updated: July 3, 2012
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