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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


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 utilization

Self-reported pain scores


Minimum age: 7 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

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