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

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ClinicalTrials.gov Identifier: NCT00252122
Recruitment Status : Terminated (Recruitment was very slow.)
First Posted : November 11, 2005
Last Update Posted : March 13, 2009
Information provided by:
Children's Hospital of Philadelphia

Brief Summary:
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 or disease Intervention/treatment Phase
Sickle Cell Disease Drug: Ketamine Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : June 2004
Primary Completion Date : November 2005
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Assessing pain scores within 48 hours after administration of the drug. Assessing decrease in pain and increase in mobility. [ Time Frame: 48 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00252122

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

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
First Posted: November 11, 2005    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Anemia, Sickle Cell
Acute Pain
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hematologic Diseases
Genetic Diseases, Inborn
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action