Low Dose Ketamine and Acute Pain Crisis

NCT04330183 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 1481617
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Sickle Cell Crisis

Keywords

ketamine; emergency department; acute pain crisis

Outcome Measures

Primary Outcomes (1)

• Pain intensity

  We anticipate a decrease in numeric pain score after ketamine administration

  4 hours

Secondary Outcomes (1)

• Emergency department length of stay

  4 hours

Study Arms (2)

Normal Saline

PLACEBO COMPARATOR

Patients here will be administered 3cc of normal saline as placebo

Drug: Normal Saline

Ketamine Interventions

EXPERIMENTAL

Patients will be administered weight based 0.3mg/kg of ketamine

Drug: Ketamine

Interventions

Ketamine DRUG

0.3mg/kg of ketamine

Ketamine Interventions

Normal Saline DRUG

3cc of normal saline

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rhode Island Hospital: lead

Study Sites (2)

Rhode Island Hospital

Providence, Rhode Island, 02905, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Vaso-Occlusive Crises; Emergencies

Interventions

Ketamine; Saline Solution

Condition Hierarchy (Ancestors)

Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Taneisha Wison, MD, ScM

  Brown Emergency Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 1, 2020
• Study Start: July 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: December 23, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)