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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00224692 |
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Date of registration:
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19/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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MK III Trial: Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine |
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Date of first enrolment:
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February 2003 |
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Target sample size:
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50 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00224692 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Evelyne JACQZ-AIGRAIN, Pr,MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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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
Age minimum:
5 Years
Age maximum:
18 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Mucositis
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Cancer
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Intervention(s)
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Drug: Low dose ketamine
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Primary Outcome(s)
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Pain score
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Secondary ID(s)
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CRC01022
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P010918
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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