Pediatric Clinical Trial
— DOLOREAPEDIAOfficial title:
Efficacy of Alfentanyl Versus Sufentanyl in Children for Pain During Treatment by Tracheal Suction in an Intensive Care Unit.
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 1 Month to 15 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Grenoble | Grenoble |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Grenoble |
France,
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. — View 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. — View 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. — View Citation
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. — View Citation
Veyckemans F. [Sedation in children: how and for who?]. Arch Pediatr. 2006 Jun;13(6):835-7. Epub 2006 May 12. French. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | COMFORT score | pain score recommended in pediatric intensive care units in France | 8 hours | Yes |
Secondary | Hemodynamic criteria | blood pressure and heart rate | 8 hours | Yes |
Secondary | Bispectral Index score | assess the level of child's sedation | 8 hours | Yes |
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