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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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00252122
Enrollment
3
Registered
2005-11-11
Start date
2004-06-30
Completion date
2007-01-31
Last updated
2009-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

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.

Interventions

DRUGKetamine

Ketamine. 0.2 mg/kg, intravenously

Sponsors

Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 18 Years
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

Design outcomes

Primary

MeasureTime frame
Assessing pain scores within 48 hours after administration of the drug. Assessing decrease in pain and increase in mobility.48 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026