TerminatedPhase 3ketamine

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

Sponsored by Assistance Publique - Hôpitaux de Paris

NCT ID
NCT00224692
Target Enrollment
50 participants
Start Date
2003-02
Est. Completion
2006-08

About This Study

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

Conditions Studied

CancerMucositis

Interventions

  • Low dose ketamine

Eligibility

Age:5 Years - 18 Years
Healthy Volunteers:No
View full 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

Study Locations (1)

Hôpital Robert Debré Service Pédiatrie-Hémato-immunologie
Paris, Île-de-France Region, France

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source