Status:
TERMINATED
Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Cancer
Mucositis
Eligibility:
All Genders
5-18 years
Phase:
PHASE3
Brief Summary
Hypothesis : Low dose ketamine has an analgesic effect in children with mucositis treated by patient-controlled analgesia with morphine
Detailed Description
Double blind versus placebo multicenter Phase III trial of kétamine in children with chemotherapy induced-mucositis treated by patient-controlled analgesia with morphine
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
August 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00224692
Start Date
February 1 2003
End Date
August 1 2006
Last Update
October 26 2006
Active Locations (1)
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1
Hôpital Robert Debré Service Pédiatrie-Hémato-immunologie
Paris, Île-de-France Region, France, 75019