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Pilot Study on the Effects of Intravenous Ketamine on Acute Pain Crisis in Patients With Sickle Cell Disease

This study has been terminated.
(Recruitment was very slow.)
Sponsor:
Information provided by:
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00252122
First received: November 9, 2005
Last updated: March 12, 2009
Last verified: March 2009
History of Changes
  Purpose

The purpose of this pilot study is to provide a preliminary assessment of the feasibility and efficacy of intravenous ketamine in controlling pain in patients with sickle cell disease (who are admitted to the hospital with severe, acute pain crisis, and who have been resistant to intravenous narcotics).


Condition Intervention Phase
Sickle Cell Disease
 Drug: Ketamine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study on the Effects of Intravenous Ketamine on Acute Pain Crisis in Patients With Sickle Cell Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Assessing pain scores within 48 hours after administration of the drug. Assessing decrease in pain and increase in mobility. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: June 2004
Study Completion Date: January 2007
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients receiving ketamine are those patients, arm 1, that are sill experiencing pain after Morphine has been given.
 Drug: Ketamine
Ketamine. 0.2 mg/kg, intravenously
Other Name: Ketalar

Detailed Description:

It is often difficult to manage acute painful crisis in patients with sickle cell disease. The usual management of these crises relies on hydration, administration of oxygen and narcotics, like morphine. A select group of patients, for unknown reasons, does not respond to this management and these patients often require prolonged use (several days) of intravenous narcotics. Narcotics have proven to be ineffective in controlling this type of pain and can cause multiple side effects (sedation, vomiting, respiratory depression). We propose to administer intravenous ketamine in this group of patients who are resistant to intravenous narcotics. Ketamine has been proven to be effective in controlling pain in multiple clinical situations. However, there are no data in the literature describing its use in patients with sickle cell disease.

  Eligibility

Ages Eligible for Study:   7 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children ages 7 to <19
  • Acute vaso-occlusive crisis
  • Persistent pain despite initial pain management with intravenous (IV) opioids

Exclusion Criteria:

  • Contraindications to the use of ketamine
  • Mental retardation or psychological conditions that may affect the proper evaluation of pain and side effects
  • Known allergy to ketamine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252122

Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Arjunan Ganesh, MD Children's Hospital of Philadelphia
  More Information

No publications provided

Responsible Party: Arjunan Ganesh, MBBS, The Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00252122     History of Changes
Other Study ID Numbers: 2004-6-3708
Study First Received: November 9, 2005
Last Updated: March 12, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013