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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01235637
Other study ID # DCIC 10 10
Secondary ID
Status Completed
Phase Phase 3
First received November 4, 2010
Last updated July 3, 2012
Start date June 2010
Est. completion date June 2012

Study information

Verified date July 2012
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
France University Hospital of Grenoble Grenoble

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (5)

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

Outcome

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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