NCT01235637

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 4, 2012

Status Verified

July 1, 2012

Enrollment Period

2 years

First QC Date

November 4, 2010

Last Update Submit

July 3, 2012

Conditions

Child ComfortMorphineIntensive Care UnitsPediatric

Keywords

COMFORT B scoreBis score

Outcome Measures

Primary Outcomes (1)

  • COMFORT score

    pain score recommended in pediatric intensive care units in France

    8 hours

Secondary Outcomes (2)

  • Hemodynamic criteria

    8 hours

  • Bispectral Index score

    8 hours

Study Arms (2)

Alfentanil

ACTIVE COMPARATOR
Drug: Alfentanil

Sufentanil

SHAM COMPARATOR
Drug: Sufentanil

Interventions

AlfentanilDRUG

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.

Alfentanil
SufentanilDRUG

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.

Sufentanil

Eligibility Criteria

Age1 Month - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Grenoble

Grenoble, France

Location

Related Publications (5)

  • 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.

    PMID: 11432213BACKGROUND

  • 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.

    PMID: 15636661BACKGROUND

  • 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.

    PMID: 15693968BACKGROUND

  • 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.

    PMID: 11907667BACKGROUND

  • 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.

    PMID: 16697580BACKGROUND

MeSH Terms

Interventions

AlfentanilSufentanil

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Isabelle WROBLEWSKI, MD PHD

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2010

First Posted

November 5, 2010

Study Start

June 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 4, 2012

Record last verified: 2012-07

Locations

FR(1)