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

Primary Purpose

Cancer, Mucositis

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Low dose ketamine
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring Mucositis, Pain, Morphine, Ketamine

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Robert Debré Service Pédiatrie-Hémato-immunologie

Outcomes

Primary Outcome Measures

Pain score

Secondary Outcome Measures

Full Information

First Posted
September 19, 2005
Last Updated
October 25, 2006
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00224692
Brief Title
Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine
Official Title
MK III Trial: Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2006
Overall Recruitment Status
Terminated
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Mucositis
Keywords
Mucositis, Pain, Morphine, Ketamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Low dose ketamine
Primary Outcome Measure Information:
Title
Pain score

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelyne JACQZ-AIGRAIN, Pr,MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Robert Debré Service Pédiatrie-Hémato-immunologie
City
Paris
State/Province
Ile de France
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

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

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