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

Children's Hospital of Philadelphia (CHOP) logo

Children's Hospital of Philadelphia (CHOP)

Status and phase

Terminated
Phase 4

Conditions

Sickle Cell Disease

Treatments

Drug: Ketamine

Study type

Interventional

Funder types

Other

Identifiers

NCT00252122
2004-6-3708

Details and patient eligibility

About

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).

Full 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.

Enrollment

3 patients

Sex

All

Ages

7 to 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

3 participants in 1 patient group

1
Experimental group
Description:
Patients receiving ketamine are those patients, arm 1, that are sill experiencing pain after Morphine has been given.
Treatment:
Drug: Ketamine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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