Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine
Phase 3
Terminated
- Conditions
- CancerMucositis
- Registration Number
- NCT00224692
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
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.
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Pain score
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hôpital Robert Debré Service Pédiatrie-Hémato-immunologie
🇫🇷Paris, Ile de France, France