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

This study has been terminated.
(Lack of enrollment and patient interest in study)
Sponsor:
Information provided by (Responsible Party):
William Zempsky, MD, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:
NCT00595530
First received: December 27, 2007
Last updated: February 29, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Sickle Cell Disease
Drug: ketamine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Low-Dose Ketamine Infusion in Acute Painful Episodes of Sickle Cell Disease: A Pilot Study

Resource links provided by NLM:


Further study details as provided by Connecticut Children's Medical Center:

Primary Outcome Measures:
  • The Number of Participants That Experience Side Effects [ Time Frame: Daily while inpatient and once a week for first 4 weeks post discharge ] [ Designated as safety issue: Yes ]
    How many participants experienced side effects while undergoing treatment with the study drug?


Secondary Outcome Measures:
  • Intravenous Opiate Utilization [ Time Frame: Every 4 hours ] [ Designated as safety issue: No ]
  • Self-reported Pain Scores [ Time Frame: Every 4 hours ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: January 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ketamine
This group will receive ketamine
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.

Other Name: Ketalar

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595530

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Connecticut Children's Medical Center
Investigators
Principal Investigator: William T Zempsky, MD Connecticut Children's Medical Center
  More Information

Responsible Party: William Zempsky, MD, Director, Pain Relief Program, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier: NCT00595530     History of Changes
Other Study ID Numbers: 07-101 
Study First Received: December 27, 2007
Results First Received: July 27, 2015
Last Updated: February 29, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No
Plan Description: There is no plan to share data as the low enrollment makes the results of this study non-generalizable.

Keywords provided by Connecticut Children's Medical Center:
ketamine
vasoocclusive pain

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016