Analgesic Effect in Children of Low-Dose Ketamine for Mucositis Treated by Patient-Controlled Analgesia With Morphine
Brief Summary
Hypothesis : Low dose ketamine has an analgesic effect in children with mucositis treated by patient-controlled analgesia with morphine
Condition or Disease
- Cancer
- Mucositis
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Terminated |
| Study results: | No Results Available |
| Age: | 5 Years to 18 Years |
| Enrollment: | 50 () |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
Masking |
|
Clinical Trial Dates
| Start date: | Feb 01, 2003 | |
|---|---|---|
| Primary Completion: | Aug 31, 2020 | |
| Completion Date: | Aug 01, 2006 | |
| Study First Posted: | Sep 23, 2005 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Oct 25, 2006 |
Sponsors / Collaborators
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Responsible Party:
N/A
No responsible party listed
Location
Double blind versus placebo multicenter Phase III trial of kétamine in children with chemotherapy induced-mucositis treated by patient-controlled analgesia with morphine
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 5 |
| Maximum Age: | 18 |
| Age Groups: | Child / Adult |
| Healthy Volunteers: | Yes |
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
* 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
Primary Outcomes
-
Pain score
More Details
| NCT Number: | NCT00224692 |
|---|---|
| Other IDs: | P010918 |
| Study URL: | https://clinicaltrials.gov/study/NCT00224692 |
Last updated: Sep 29, 2023