Dettagli per singolo studio

DEC-NET Serial number FR238

Published online	27/05/2004 17.04.00
Last updated	19/09/2005 10.54.16

Other protocol ID number	CRC01022
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	STOMATITIS
Experimental drug
Ketamine Treatment regimen (dosage and duration) continuous infusion of 2µg/kg/min. if side effect the dose us reduced to 1µg/kg/min
Gender	Both
Age (range)	5-18 years
Eligibility criteria
Inclusion criteria
-Informed written consent signed by the parents or if possible subject assent. - Stomatitis complicating chemotherapy or hematopoietic graft. -No neurological or psycological limitation to use patientcontrolled analgesia or pain evaluation score (VAE). - Pain not controlled by acetaminophen (10mg/kg/4h)or proacetaminophen 20mg/kg/4) : defined by VAE test > 30 during 4 hours or more.
Exclusion criteria
- Children previously included in this study. - Psychomotor development < 5 years. - Depression or major depressif episode according to the DSMIV definition. - Creatinin > 3N - Bilirubin > 3N - Gamma GT> 5N - SGOT ou SGPT > 5N
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety Pharmacokinetics
Design	Controlled Randomised Blinded Single blind
Purpose of study
To evaluate the efficacy of patient controlled analgesia with morphine associated with low dose ketamine, in children with stomatitis complicating chemotherapy and hematopoïetic graft.




Summary of study design, objectives, and ongoing research findings
Phase III trial comparing morphine patient controlled analgesia alone or associated with low dose ketamine for the treatment of the stomatitis post chemotherapy and bone marrow transplantation. Pain, morphine consumption and side effects are evaluated every 4 hours. A pharmacokinetic study of ketamine and norketamine is carried out. Efficacy is evaluated by the pain score, morphine consumption and side effects.