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

Phase 4

Terminated

• Conditions: Sickle Cell Disease
• Interventions: Drug: Ketamine

• Registration Number: NCT00252122
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2004-06
• Primary Completion: 2005-11
• Study First Submitted: 2005-11-09
• Study First Submitted QC: 2005-11-09
• Study First Posted: 2005-11-11
• Study Completion: 2007-01
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-12
• Last Update Posted: 2009-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Ketamine	Patients receiving ketamine are those patients, arm 1, that are sill experiencing pain after Morphine has been given.

Primary Outcome Measures

Name	Time	Method
Assessing pain scores within 48 hours after administration of the drug. Assessing decrease in pain and increase in mobility.	48 hours

Trial Locations

Locations (1)

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States