Low-Dose Ketamine Infusion for Children With Sickle Cell Disease-Related Pain
Information source: Connecticut Children's Medical Center
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sickle Cell Disease
Intervention: ketamine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Connecticut Children's Medical Center Official(s) and/or principal investigator(s): William T Zempsky, MD, Principal Investigator, Affiliation: Connecticut Children's Medical Center
Summary
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.
Clinical Details
Official title: Use of Low-Dose Ketamine Infusion in Acute Painful Episodes of Sickle Cell Disease: A Pilot Study
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Side effects
Secondary outcome: Intravenous opiate utilizationSelf-reported pain scores
Eligibility
Minimum age: 7 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- CCMC: Children ages 7-22 years (inclusive) with documented sickle cell disease
- UCHC: Adults 18 years (inclusive) and above with documented sickle cell disease
- Sudden onset of acute pain consistent with a vasoocclusive episode -Pain requiring
hospitalization, placement on pain protocol, and patient- controlled opiates
- Pain score of greater than or equal to 5 out of 10 when ketamine infusion is started
- Cognitive ability to report pain on a 0 to 10 Numerical Rating Scale (NRS)
- At least one prior hospitalization for vasoocclusive pain at CCMC in the previous 24
months
- Parental consent and child assent
Exclusion Criteria:
- Children hospitalized for a primary diagnosis other than vasoocclusive episode
- Concurrent Acute Chest Syndrome (ACS)
- Hemoglobin < 5 mg/dL
- Concurrent history of glaucoma or raised intracranial pressure
- Signs or symptoms consistent with stroke
- History of liver or renal dysfunction
- Pregnancy (females age 12 and above must have pregnancy test)
- Simultaneous participation in investigational drug study
- Primary language spoken other than English
- No hospitalizations to CCMC for vasoocclusive pain in the previous 24 months
Locations and Contacts
University of Connecticut Health Center, Farmington, Connecticut 06030, United States
Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States
Additional Information
Starting date: January 2008
Last updated: July 29, 2013
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