MK III Trial: Analgesic Effect in Children of Low-Dose Ketamine for 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
- 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
- Not presenting a neurological or psychological difficulty at the use of the PCA or a
- 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.
- 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
- Hepatic or renal anomaly major (rank 3 or 4 of the scale of toxicity NCI CTC v2.0)
- Gamma WP>3N
- SGOT or SGPT >5N
Type of Study:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Evelyne JACQZ-AIGRAIN, Pr,MD,PhD
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health