Low-Dose Ketamine Infusion for Children With Sickle Cell Disease-Related Pain

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ClinicalTrials.gov Identifier: NCT00595530

Recruitment Status : Terminated (Lack of enrollment and patient interest in study)

First Posted : January 16, 2008

Results First Posted : March 30, 2016

Last Update Posted : March 30, 2016

Sponsor:

Information provided by (Responsible Party):

William Zempsky, MD, Connecticut Children's Medical Center

Study Description

Brief Summary:

Acute pain episodes associated with sickle cell disease (SCD) are very difficult to manage effectively. Opioid tolerance and side effects have been major roadblocks in our ability to provide these patients with adequate pain relief. This pilot study is designed to examine the safety and feasibility of using ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, in the inpatient seeing with children and adolescents who have sickle cell vasoocclusive pain. Previous research suggests that in subanesthetic doses, ketamine may be able to prevent the development of opiate tolerance and facilitate better pain relief with lower opiate doses, allowing for less respiratory depression, less sedation, easier ambulation, less deconditioning, shorter hospital stays, and better quality of life. The goal of this pilot study is to evaluate the safety and feasibility of using a continuous infusion of ketamine, in conjunction with opiates, in the inpatient setting for sickle cell vasoocclusive pain. It is hypothesized that using a low dose ketamine infusion in conjunction with opiates will be a safe and feasible practice for the treatment of sickle cell pain.

Condition or disease	Intervention/treatment	Phase
Sickle Cell Disease	Drug: ketamine	Phase 2

Show Detailed Description

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	3 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Use of Low-Dose Ketamine Infusion in Acute Painful Episodes of Sickle Cell Disease: A Pilot Study
Study Start Date :	January 2008
Actual Primary Completion Date :	June 2011
Actual Study Completion Date :	June 2011

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Sickle cell disease

Drug Information available for: Ketamine

Genetic and Rare Diseases Information Center resources: Sickle Cell Anemia

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ketamine This group will receive ketamine	Drug: ketamine Medication administered via IV. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hr, 0.1 mg/kg/hr, 0.15 mg/kg/hr, and 0.2 mg/kg/hr. Dosing Regimen: Patients begin the ketamine infusion at 0.05 mg/kg/hr. 4 or more hrs after infusion is started, the dose may be increased to 0.1 mg/kg/hr if: patient's pain has not improved to an acceptable level side effects remain acceptable 4 hrs or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hr 4 hrs or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour Maximum dose of ketamine is limited to 300 mg per 24 hrs Patient may receive ketamine up to 72 hrs after initiation. Other Name: Ketalar

Arm

Intervention/treatment

Experimental: Ketamine

This group will receive ketamine

Drug: ketamine

Medication administered via IV. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hr, 0.1 mg/kg/hr, 0.15 mg/kg/hr, and 0.2 mg/kg/hr.

Dosing Regimen:

Patients begin the ketamine infusion at 0.05 mg/kg/hr.
4 or more hrs after infusion is started, the dose may be increased to 0.1 mg/kg/hr if:
1. patient's pain has not improved to an acceptable level
2. side effects remain acceptable
4 hrs or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hr
4 hrs or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour
Maximum dose of ketamine is limited to 300 mg per 24 hrs

Patient may receive ketamine up to 72 hrs after initiation.

Other Name: Ketalar

Outcome Measures

Primary Outcome Measures :

The Number of Participants That Experience Side Effects [ Time Frame: Daily while inpatient and once a week for first 4 weeks post discharge ]
How many participants experienced side effects while undergoing treatment with the study drug?

Secondary Outcome Measures :

Intravenous Opiate Utilization [ Time Frame: Every 4 hours ]
Self-reported Pain Scores [ Time Frame: Every 4 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	7 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

CCMC: Children ages 7-22 years (inclusive) with documented sickle cell disease
UCHC: Adults 18 years (inclusive) and above with documented sickle cell disease
Sudden onset of acute pain consistent with a vasoocclusive episode -Pain requiring hospitalization, placement on pain protocol, and patient- controlled opiates
Pain score of greater than or equal to 5 out of 10 when ketamine infusion is started
Cognitive ability to report pain on a 0 to 10 Numerical Rating Scale (NRS)
At least one prior hospitalization for vasoocclusive pain at CCMC in the previous 24 months
Parental consent and child assent

Exclusion Criteria:

Children hospitalized for a primary diagnosis other than vasoocclusive episode
Concurrent Acute Chest Syndrome (ACS)
Hemoglobin < 5 mg/dL
Concurrent history of glaucoma or raised intracranial pressure
Signs or symptoms consistent with stroke
History of liver or renal dysfunction
Pregnancy (females age 12 and above must have pregnancy test)
Simultaneous participation in investigational drug study
Primary language spoken other than English
No hospitalizations to CCMC for vasoocclusive pain in the previous 24 months

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00595530

Locations


United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106

Sponsors and Collaborators

Connecticut Children's Medical Center

Investigators


Principal Investigator:	William T Zempsky, MD	Connecticut Children's Medical Center

More Information


Responsible Party:	William Zempsky, MD, Director, Pain Relief Program, Connecticut Children's Medical Center
ClinicalTrials.gov Identifier:	NCT00595530 History of Changes
Other Study ID Numbers:	07-101
First Posted:	January 16, 2008 Key Record Dates
Results First Posted:	March 30, 2016
Last Update Posted:	March 30, 2016
Last Verified:	February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	There is no plan to share data as the low enrollment makes the results of this study non-generalizable.

Keywords provided by William Zempsky, MD, Connecticut Children's Medical Center:


ketamine vasoocclusive pain

Additional relevant MeSH terms:


Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn Ketamine Analgesics Sensory System Agents Peripheral Nervous System Agents	Physiological Effects of Drugs Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action

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