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

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

This study has been terminated.

Sponsored by:	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

ChemIDplus related topics:

Ketamine Ketamine hydrochloride

U.S. FDA Resources

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

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

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

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Mucositis

Pain

Morphine

Ketamine

Study placed in the following topic categories:

Mouth Diseases

Excitatory Amino Acids

Morphine

Digestive System Diseases

Mucositis

Gastrointestinal Diseases

Ketamine

Pain

Stomatognathic Diseases

Gastroenteritis

Additional relevant MeSH terms:

Anesthetics, Intravenous

Neurotransmitter Agents

Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs

Anesthetics

Central Nervous System Depressants

Narcotics

Excitatory Amino Acid Agents

Anesthetics, Dissociative

Pharmacologic Actions

Sensory System Agents

Anesthetics, General

Therapeutic Uses

Peripheral Nervous System Agents

Analgesics

Central Nervous System Agents

Analgesics, Opioid

Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on October 10, 2008