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

• Status: Terminated
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Analgesics; Ketamine; Morphine

Criteria

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