ClinicalTrials.Veeva

Menu

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

A

Assistance Publique - Hôpitaux de Paris

Status and phase

Terminated
Phase 3

Conditions

Cancer
Mucositis

Treatments

Drug: Low dose ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT00224692
CRC01022
P010918

Details and patient eligibility

About

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

Full description

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

Sex

All

Ages

5 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems