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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00224692
• Other study ID #: P010918
• Secondary ID: CRC01022
• Status: Terminated
• Phase: Phase 3
• First received: September 19, 2005
• Last updated: October 25, 2006
• Start date: February 2003
• Est. completion date: August 2006

Study information

• Verified date: October 2006
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

Double blind versus placebo multicenter Phase III trial of kétamine in children with chemotherapy induced-mucositis treated by patient-controlled analgesia with morphine

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer
• Mucositis

Intervention

Drug:
• Low dose ketamine

Locations

Country	Name	City	State
France	Hôpital Robert Debré Service Pédiatrie-Hémato-immunologie	Paris	Ile de France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score