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

This study has been terminated.

First Received: September 19, 2005 Last Updated: October 25, 2006 History of Changes

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00224692

Purpose

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

Condition	Intervention	Phase
Cancer Mucositis	Drug: Low dose ketamine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	MK III Trial: Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine

Resource links provided by NLM:

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Pain score

Estimated Enrollment:	50
Study Start Date:	February 2003
Estimated Study Completion Date:	August 2006

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

Eligibility

Ages Eligible for Study:	5 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00224692

Locations

France, Ile De France
Hôpital Robert Debré Service Pédiatrie-Hémato-immunologie
PARIS, Ile De France, France, 75019

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Evelyne JACQZ-AIGRAIN, Pr,MD,PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Study ID Numbers:	P010918, CRC01022
Study First Received:	September 19, 2005
Last Updated:	October 25, 2006
ClinicalTrials.gov Identifier:	NCT00224692 History of Changes
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Mucositis
Pain
Morphine
Ketamine

Additional relevant MeSH terms:

Mouth Diseases
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Physiological Effects of Drugs
Anesthetics
Excitatory Amino Acid Agents
Sensory System Agents
Therapeutic Uses
Ketamine
Analgesics
Analgesics, Opioid
Excitatory Amino Acid Antagonists

Anesthetics, Intravenous
Morphine
Mucositis
Central Nervous System Depressants
Narcotics
Pharmacologic Actions
Anesthetics, Dissociative
Digestive System Diseases
Anesthetics, General
Peripheral Nervous System Agents
Stomatognathic Diseases
Gastroenteritis
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010