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

Phase 3

Terminated

• Conditions: Cancer; Mucositis

• Registration Number: NCT00224692
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2005-09-19
• Study First Submitted QC: 2005-09-19
• Study First Posted: 2005-09-23
• Study Completion: 2006-08
• Status Verified: 2006-10
• Last Update Submitted: 2006-10-25
• Last Update Posted: 2006-10-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain score

Trial Locations

Locations (1)

Hôpital Robert Debré Service Pédiatrie-Hémato-immunologie; 🇫🇷 Paris, Ile de France, France