Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine

This study has been terminated.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00224692
First received: September 19, 2005
Last updated: October 25, 2006
Last verified: October 2006

September 19, 2005
October 25, 2006
February 2003
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Pain score
Same as current
Complete list of historical versions of study NCT00224692 on ClinicalTrials.gov Archive Site
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Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine
MK III Trial: Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine

Hypothesis : Low dose ketamine has an analgesic effect in children with mucositis treated by patient-controlled analgesia with morphine

Double blind versus placebo multicenter Phase III trial of kétamine in children with chemotherapy induced-mucositis treated by patient-controlled analgesia with morphine

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Cancer
  • Mucositis
Drug: Low dose ketamine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
August 2006
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Inclusion Criteria:

  • Painful mucositis
  • Child from 5 to 18 years.
  • Presenting mucitis induced by chemotherapy or a conditioning of graft hematopoïetic.
  • A pain not controlled by systematic paracetamol (10mg/kg/4h) or a the propacetamol (20mg/kg/4h).
  • Not presenting a neurological or psychological difficulty at the use of the PCA or a EVA.
  • First morphine amount going back to less 48h, and lass administration dating of more than 4h at the time of the beginning of the perfusion of Ketamine/placebo (EVA > 30 after stop morphine).
  • Assent signed by the parents and each time possible by the child.

Exclusion Criteria:

  • The child was already included in the study.
  • The age of psychomotor development is lower than 5 years
  • Presence of a depression or a major depressive episode according to definition DSM IV.
  • Hepatic or renal anomaly major (rank 3 or 4 of the scale of toxicity NCI CTC v2.0)
  • Bilirubin>3N
  • Gamma WP>3N
  • SGOT or SGPT >5N
  • Creatinin>3N
Both
5 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00224692
P010918, CRC01022
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Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Evelyne JACQZ-AIGRAIN, Pr,MD,PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP