Ketamine Sickle Cell Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-11-01

Brief Summary

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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.

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Detailed Description

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Conditions

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SC Disease Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Prospective Clinical Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ketamine

Continuous infusion of Ketamine 0.3 to 0.5 mg/kg per hour PCA Dilaudid 2.0-2.5 mg

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Low dose continuous infusion of ketamine 0.3 to 0.5 mg/kg per hour

Opioid Only

Patient-controlled analgesia Dilaudid 2.0-2.5 mg

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ketamine

Low dose continuous infusion of ketamine 0.3 to 0.5 mg/kg per hour

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No