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| Sponsored by: |
University of British Columbia |
|---|---|
| Information provided by: | University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT00474110 |
Purpose
The treatment of cancer in children may result in an extremely painful condition called oral mucositis when the cells lining the mouth are injured due to the cancer medication. Patients with this condition are often unable to take anything by mouth or to swallow their own saliva. This severe pain may last for as long as 2 weeks. A survey of our previous 22 patients showed high daily pain scores despite the use of intravenous (given through a small tube in a vein) opioid medications (family of pain relieving drugs, e.g. morphine and hydromorphone).
The purpose of this pilot study is to determine which of 3 concentrations of ketamine to combine with hydromorphone to provide the best pain relief with minimum side effects. The results from this study will allow us to do a larger study to compare the best concentration found from this study to standard treatment. If successful, this combination of ketamine and hydromorphone will also be used to treat other pain problems in children.
| Condition | Intervention | Phase |
|---|---|---|
|
Mucositis |
Drug: Ketamine & hydromorphone |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Ketamine and Hydromorphone PCA Analgesia for Antineoplastic-Induced Pediatric Mucositis |
| Estimated Enrollment: | 20 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Ketamine and hydromorphone for patient-controlled relief in children's mucositis.
|
Drug: Ketamine & hydromorphone
See Detailed Description
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 5 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Joanne Lim | 604-875-2000 ext 6669 | jlim2@cw.bc.ca |
| Canada, British Columbia | |
| BC Children's Hospital | |
| Vancouver, British Columbia, Canada, V6H 3V4 | |
| Principal Investigator: | Carolyne Montgomery, MD | University of British Columbia |
| Study Director: | Mark Ansermino, MD | University of British Columbia |
| Study Director: | Caron Strahlendorf, MD | University of British Columbia |
| Study Director: | Robert Purdy, MD | University of British Columbia |
| Study Director: | Colleen Court, MD | University of British Columbia |
| Study Director: | Joanne Lim | University of British Columbia |
More Information
| Responsible Party: | University of British Columbia ( Dr Carolyne Montgomery ) |
| Study ID Numbers: | H06-03799 |
| Study First Received: | May 14, 2007 |
| Last Updated: | September 22, 2008 |
| ClinicalTrials.gov Identifier: | NCT00474110 |
| Health Authority: | Canada: Health Canada |
|
Ketamine hydromorphone pediatric mucositis |
|
Hydromorphone Mouth Diseases Excitatory Amino Acids Digestive System Diseases Mucositis |
Gastrointestinal Diseases Ketamine Pain Stomatognathic Diseases Gastroenteritis |
|
Anesthetics, Intravenous Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Excitatory Amino Acid Agents Anesthetics, Dissociative |
Pharmacologic Actions Sensory System Agents Anesthetics, General Therapeutic Uses Peripheral Nervous System Agents Analgesics Central Nervous System Agents Analgesics, Opioid Excitatory Amino Acid Antagonists |
