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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00224692
First Posted: September 23, 2005
Last Update Posted: October 26, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Assistance Publique - Hôpitaux de Paris
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00224692


Locations
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

ClinicalTrials.gov Identifier: NCT00224692     History of Changes
Other Study ID Numbers: P010918
CRC01022
First Submitted: September 19, 2005
First Posted: September 23, 2005
Last Update Posted: October 26, 2006
Last Verified: October 2006

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Mucositis
Pain
Morphine
Ketamine

Additional relevant MeSH terms:
Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Morphine
Ketamine
Analgesics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action