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

Assistance Publique - Hôpitaux de Paris

Status and phase

Terminated

Phase 3

Conditions

Cancer

Mucositis

Treatments

Drug: Low dose ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT00224692

CRC01022

P010918

Details and patient eligibility

About

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

Full description

Double blind versus placebo multicenter Phase III trial of kétamine in children with chemotherapy induced-mucositis treated by patient-controlled analgesia with morphine

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

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