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

NCT00595530 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-08-21

Study results available
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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.

Conditions

Interventions

DRUG

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. Dosing Regimen: * Patients begin the ketamine infusion at 0.05 mg/kg/hr. * 4 or more hrs after infusion is started, the dose may be increased to 0.1 mg/kg/hr if: 1. patient's pain has not improved to an acceptable level 2. side effects remain acceptable * 4 hrs or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hr * 4 hrs or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour * Maximum dose of ketamine is limited to 300 mg per 24 hrs Patient may receive ketamine up to 72 hrs after initiation.

Sponsors & Collaborators

  • Connecticut Children's Medical Center

    lead OTHER

Principal Investigators

  • William T Zempsky, MD · Connecticut Children's Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-04
Primary Completion
2010-02-12
Completion
2010-02-12

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00595530 on ClinicalTrials.gov