Low Dose Ketamine for Acute Pain Crisis in Patients With Sickle Cell Disease

Study point of contact

Taneisha Wilson, MD, ScM
401.444.5027
[email protected]

Locations

2 United States sites

Age

> 18 Years

Phase

Phase 4

Study type

Interventional

Gender

All

Interventions

Drug

Compensation

Unknown

About the study

BACKGROUND:

Current treatment standard for acute pain crisis in sickle cell disease (SCD) is largely
supportive care: opioid analgesics, hydration, oxygen, and blood transfusion. Sickle cell
disease (SCD) is a chronic condition associated with serious and disabling acute consequences
such as a vaso-occlusive (VOC) or pain crisis. Uncontrolled pain is the hallmark of a VOC,
and often results in acute unscheduled care in the patient’s clinic or hospital emergency
department (ED). During these pain crises, patients sometimes require high doses of opioids
for analgesia. Opioid analgesics are fraught with challenges including the development of
tolerance, dependence, and opioid-induced hyperalgesia (whereby the use of opioids actually
makes patients more sensitive to pain). Finding non-opioid alternatives for intravenous
analgesia is problematic based on the limited availability this class of drugs. Ketamine is a
potent N-methyl-D-aspartate (NMDA) receptor antagonist that even at low doses has
demonstrated efficacy as an adjunct to opioids for acute pain control.

OBJECTIVE:

The investigators will determine the comparative efficacy of low doses of ketamine as an
adjunct to opioids versus standard care (opioids alone) for the treatment of acute severe
pain in patients with sickle cell related pain crisis.

METHODS:

The investigators propose a double-blinded, randomized, placebo-controlled pilot study to
determine the efficacy of ketamine 0.3mg/kg vs. placebo for the treatment of acute pain
crisis. The investigators will include all eligible emergency department ≥18 years. The
investigators will stratify 42 patients by location, 21 patients per site. Numeric Rating
Scale (NRS) will be recorded as a part of the study log at 0, 1, 2 and 3hrs after the study
drug administration.

HYPOTHESIS:

The investigators hypothesize that the ketamine will decrease overall pain intensity, visit
length of stay, and hospitalizations.

participation requirements

– All English-speaking adult patients >=18yrs old patients presenting with acute pain
crisis

participation restrictions

– Inability to provide consent,

– Allergy to ketamine

– Pregnant or breastfeeding. W

– Signs and symptoms of intracranial hypertension

– Neurologic deficits

– Headache only

– Temperature >102F

– Sustained blood pressure >=180/110

– Sustained heart rate >130

– Current priapism

– Patients requiring a blood transfusion at the time of acute presentation

Locations

  • Providence, Rhode Island, United States, Rhode Island Hospital, 02905 [Recruiting]
  • Providence, Rhode Island, United States, The Miriam Hospital, 02906 [Recruiting]
Last updated 2020-07-06 Enroll Now