Overview

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