Pilot Study on the Effects of Intravenous Ketamine on Acute Pain Crisis in Patients With Sickle Cell Disease
The purpose of this pilot study is to provide a preliminary assessment of the feasibility and efficacy of intravenous ketamine in controlling pain in patients with sickle cell disease (who are admitted to the hospital with severe, acute pain crisis, and who have been resistant to intravenous narcotics).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study on the Effects of Intravenous Ketamine on Acute Pain Crisis in Patients With Sickle Cell Disease|
- Assessing pain scores within 48 hours after administration of the drug. Assessing decrease in pain and increase in mobility. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
|Study Start Date:||June 2004|
|Study Completion Date:||January 2007|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
Patients receiving ketamine are those patients, arm 1, that are sill experiencing pain after Morphine has been given.
Ketamine. 0.2 mg/kg, intravenously
Other Name: Ketalar
It is often difficult to manage acute painful crisis in patients with sickle cell disease. The usual management of these crises relies on hydration, administration of oxygen and narcotics, like morphine. A select group of patients, for unknown reasons, does not respond to this management and these patients often require prolonged use (several days) of intravenous narcotics. Narcotics have proven to be ineffective in controlling this type of pain and can cause multiple side effects (sedation, vomiting, respiratory depression). We propose to administer intravenous ketamine in this group of patients who are resistant to intravenous narcotics. Ketamine has been proven to be effective in controlling pain in multiple clinical situations. However, there are no data in the literature describing its use in patients with sickle cell disease.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252122
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Arjunan Ganesh, MD||Children's Hospital of Philadelphia|