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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00224692

Enrollment

Registered

2005-09-23

Start date

2003-02-28

Completion date

2006-08-31

Last updated

2006-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Mucositis

Keywords

Mucositis, Pain, Morphine, Ketamine

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

Interventions

DRUGLow dose ketamine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

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

Design outcomes

Primary

Measure	Time frame
Pain score	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026