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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00252122
• Other study ID #: 2004-6-3708
• Status: Terminated
• Phase: Phase 4
• First received: November 9, 2005
• Last updated: March 12, 2009
• Start date: June 2004
• Est. completion date: January 2007

Study information

• Verified date: March 2009
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 2007
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Drug:
• Ketamine
Ketamine. 0.2 mg/kg, intravenously

Locations

Country	Name	City	State
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessing pain scores within 48 hours after administration of the drug. Assessing decrease in pain and increase in mobility.		48 hours	No