Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine
Information source: Assistance Publique - Hôpitaux de Paris
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer; Mucositis
Intervention: Low dose ketamine (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Assistance Publique - Hôpitaux de Paris Official(s) and/or principal investigator(s):
Evelyne JACQZ-AIGRAIN, Pr,MD,PhD, Principal Investigator, Affiliation: Assistance Publique - Hôpitaux de Paris
Summary
Hypothesis : Low dose ketamine has an analgesic effect in children with mucositis treated by
patient-controlled analgesia with morphine
Clinical Details
Official title: MK III Trial: Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Pain score
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
Minimum age: 5 Years.
Maximum age: 18 Years.
Gender(s): Both.
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
Locations and Contacts
Hôpital Robert Debré Service Pédiatrie-Hémato-immunologie, PARIS, Ile De France 75019, France
Additional Information
Starting date: February 2003
Ending date: August 2006
Last updated: October 25, 2006
|
