Low-Dose Ketamine Infusion for Children With Sickle Cell Disease-Related Pain
Acute pain episodes associated with sickle cell disease (SCD) are very difficult to manage effectively. Opioid tolerance and side effects have been major roadblocks in our ability to provide these patients with adequate pain relief. This pilot study is designed to examine the safety and feasibility of using ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, in the inpatient seeing with children and adolescents who have sickle cell vasoocclusive pain. Previous research suggests that in subanesthetic doses, ketamine may be able to prevent the development of opiate tolerance and facilitate better pain relief with lower opiate doses, allowing for less respiratory depression, less sedation, easier ambulation, less deconditioning, shorter hospital stays, and better quality of life. The goal of this pilot study is to evaluate the safety and feasibility of using a continuous infusion of ketamine, in conjunction with opiates, in the inpatient setting for sickle cell vasoocclusive pain. It is hypothesized that using a low dose ketamine infusion in conjunction with opiates will be a safe and feasible practice for the treatment of sickle cell pain.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Use of Low-Dose Ketamine Infusion in Acute Painful Episodes of Sickle Cell Disease: A Pilot Study|
- Side effects [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
- Intravenous opiate utilization [ Time Frame: Every 4 hours ] [ Designated as safety issue: No ]
- Self-reported pain scores [ Time Frame: Every 4 hours ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
This group will receive ketamine
The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.
The patient may receive ketamine up to 72 hours after initiation.
Other Name: Ketalar
|United States, Connecticut|
|University of Connecticut Health Center|
|Farmington, Connecticut, United States, 06030|
|Connecticut Children's Medical Center|
|Hartford, Connecticut, United States, 06106|
|Principal Investigator:||William T Zempsky, MD||Connecticut Children's Medical Center|