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

November 9, 2005
March 12, 2009
June 2004
November 2005   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00252122 on ClinicalTrials.gov Archive Site
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Pilot Study on the Effects of Intravenous Ketamine on Acute Pain Crisis in Patients With Sickle Cell Disease
A Pilot Study on the Effects of Intravenous Ketamine on Acute Pain Crisis in Patients With Sickle Cell Disease

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).

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Sickle Cell Disease
Drug: Ketamine
Ketamine. 0.2 mg/kg, intravenously
Other Name: Ketalar
Experimental: 1
Patients receiving ketamine are those patients, arm 1, that are sill experiencing pain after Morphine has been given.
Intervention: Drug: Ketamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
3
January 2007
November 2005   (final data collection date for primary outcome measure)

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
Both
7 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00252122
2004-6-3708
No
Arjunan Ganesh, MBBS, The Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
Not Provided
Principal Investigator: Arjunan Ganesh, MD Children's Hospital of Philadelphia
Children's Hospital of Philadelphia
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP