Ketamine Sickle Cell Disease (SCD)

September 24, 2018 updated by: University of South Florida

A Randomized Controlled Trial to Determine the Efficacy of Ketamine as an Adjunct for Pain Management in Patients With Sickle Cell Crisis

Sickle cell disease (SCD) often results in acute vaso-occlusive crisis (VOC), an obstruction of blood vessels resulting in ischemic injury and pain. The pain experienced during these episodes is due to a wide range of pathophysiological processes. Though recent studies have begun to unravel the underlying mechanisms of these processes, literature focused on pain management for sickle cell disease is scarce. Opioids and non-steroidal anti-inflammatory drugs (NSAIDs) remain the predominate treatment for VOC.

However, the efficacy of these treatments has come into question. A large sub-set of patients with SCD report continued pain despite treatment with opioids. Tolerance and opioid-induced hyperalgesia (OIH) may be responsible for unresponsiveness to opioid-centric treatment modalities. New classes of drugs are being tested to prevent and treat acute pain associated with SCD, but in the meantime physicians are looking to existing therapies to bridge the gap.

The N-methyl-d-aspartate (NMDA) receptor has been implicated in both tolerance and OIH. As a NMDA receptor agonist, ketamine has been shown to modulate opioid tolerance and OIH in animal models and clinical settings. Ketamine utilized as a low dose continuous infusion could benefit patients with SCD related pain that are unresponsive to opioid analgesics. Based on limited studies of adjuvant ketamine use for pain management, low-dose ketamine continuous infusion appears safe. Further clinical investigations are warranted to fully support the use of low-dose ketamine infusion in patients with SCD-related pain.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects diagnosed with sickle cell anemia
  • Adults aged 18 and older
  • Subjects who have given written consent

Exclusion Criteria:

  • Subjects who are pregnant
  • Subjects younger than 18 years
  • Subjects known or suspected to have an allergy to opiates/opioids, muscle relaxants or other similar medications
  • Subjects who have a contraindication to ketamine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ketamine
Continuous infusion of Ketamine 0.3 to 0.5 mg/kg per hour PCA Dilaudid 2.0-2.5 mg
Drug: Ketamine
Low dose continuous infusion of ketamine 0.3 to 0.5 mg/kg per hour
NO_INTERVENTION: Opioid Only
Patient-controlled analgesia Dilaudid 2.0-2.5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total opioid Use in milligrams morphine equivalents
Time Frame: 1-3 hours
Total opioid Use in milligrams morphine equivalents
1-3 hours
Pain scores measured on the Visual Analog Scale 0 - 10
Time Frame: 1-3 hours
Pain scores measured on the Visual Analog Scale 0 - 10
1-3 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost of pharmacotherapy
Time Frame: 1 day
monetary cost of intervention used
1 day
Length of hospital stay
Time Frame: 1-7 days
Length of stay in the hospital
1-7 days
Nausea and vomiting scores Visual Analog Scale 0 - 10
Time Frame: 1-3 hours
Nausea and vomiting scores Visual Analog Scale 0 - 10
1-3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of South Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2018

Primary Completion (ANTICIPATED)

September 1, 2019

Study Completion (ANTICIPATED)

November 1, 2019

Study Registration Dates

First Submitted

April 10, 2018

First Submitted That Met QC Criteria

April 17, 2018

First Posted (ACTUAL)

April 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 26, 2018

Last Update Submitted That Met QC Criteria

September 24, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00033576

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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