Low-Dose Ketamine Infusion for Children With Sickle Cell Disease-Related Pain

• Status: Terminated
• Trial end date: 2010-02-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Connecticut Children's Medical Center
• Treatments: Ketamine

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