NCT00252122

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2004

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 11, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

March 13, 2009

Status Verified

March 1, 2009

Enrollment Period

1.4 years

First QC Date

November 9, 2005

Last Update Submit

March 12, 2009

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

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

    48 hours

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Ketamine

Interventions

KetamineDRUG

Ketamine. 0.2 mg/kg, intravenously

Also known as: Ketalar
1

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children ages 7 to \<19
  • Acute vaso-occlusive crisis
  • Persistent pain despite initial pain management with intravenous (IV) opioids

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Arjunan Ganesh, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2005

First Posted

November 11, 2005

Study Start

June 1, 2004

Primary Completion

November 1, 2005

Study Completion

January 1, 2007

Last Updated

March 13, 2009

Record last verified: 2009-03

Locations

US(1)