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


Phase 3
5 Years
18 Years
Not Enrolling
Both
Cancer, Mucositis

Thank you

Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pain score

Principal Investigator

Evelyne JACQZ-AIGRAIN, Pr,MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris

Authority:

France: Ministry of Health

Study ID:

P010918

NCT ID:

NCT00224692

Start Date:

February 2003

Completion Date:

August 2006

Related Keywords:

  • Cancer
  • Mucositis
  • Mucositis
  • Pain
  • Morphine
  • Ketamine
  • Mucositis

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