Low-Dose Ketamine Infusion for Children With Sickle Cell Disease-Related Pain
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|ClinicalTrials.gov Identifier: NCT00595530|
Recruitment Status : Terminated (Lack of enrollment and patient interest in study)
First Posted : January 16, 2008
Results First Posted : March 30, 2016
Last Update Posted : August 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Drug: ketamine||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Low-Dose Ketamine Infusion in Acute Painful Episodes of Sickle Cell Disease: A Pilot Study|
|Actual Study Start Date :||March 4, 2008|
|Actual Primary Completion Date :||February 12, 2010|
|Actual Study Completion Date :||February 12, 2010|
This group will receive ketamine
Medication administered via IV. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hr, 0.1 mg/kg/hr, 0.15 mg/kg/hr, and 0.2 mg/kg/hr.
Patient may receive ketamine up to 72 hrs after initiation.
Other Name: Ketalar
- Number of Participants With Improvement in Pain Scores of >2 Points on the Pain Scale [ Time Frame: Baseline then daily while inpatient, up to 72 hours ]Determine if there is an apparent improvement in pain control with the ketamine infusion based on the investigator's discretion and comparison to past pain scores. Pain was scored on a scale from 0 to 10. Zero equaled no pain and 10 equaled a lot of pain.
- Number of Participants Who Showed a Reduction of Opioid Utilization While on IV Ketamine [ Time Frame: Baseline then daily while inpatient, up to 72 hours ]Looking at the reduction of opioid utilization while on IV Ketamine. Three participants were enrolled in the study, therefore a comprehensive analysis could not be done due to the low enrollment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00595530
|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|