Clinical trial NCT01235637: Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction
Official title: Efficacy of Alfentanyl Versus Sufentanyl in Children for Pain During Treatment by Tracheal Suction in an Intensive Care Unit.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Child Comfort
Morphine
Intensive Care Units
Pediatric
Keywords: COMFORT B score
Bis score
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2010-11-05
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: COMFORT score
timeFrame: 8 hours
Secondary outcomes:
measure: Hemodynamic criteria
timeFrame: 8 hours
measure: Bispectral Index score
timeFrame: 8 hours
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: Isabelle WROBLEWSKI, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.