Alfentanil Versus Sufentanil for Pain in Children During for Tracheal Suction

Pediatric Clinical Trial

— DOLOREAPEDIA  

Official title:

Efficacy of Alfentanyl Versus Sufentanyl in Children for Pain During Treatment by Tracheal Suction in an Intensive Care Unit.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01235637
• Other study ID #: DCIC 10 10
• 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

• Child Comfort
• Intensive Care Units
• Morphine
• Pediatric

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