Single-dose Ketamine for the Reduction of Pain and Depression in the Emergency Department

NCT03436121 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: PRO17090065
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

In this proposal, the investigators will determine if a single dose of intravenous (IV) ketamine (in combination with midazolam) reduces pain severity, depressive symptoms and need for opiate analgesics both in the ED and in the acute recovery period after ED discharge. The investigators will compare the ketamine arm to an active placebo-controlled arm (with midazolam).

Conditions

Acute Pain; Depression

Outcome Measures

Primary Outcomes (1)

• Pain Intensity in the ED

  Pain Numeric Rating Scale (PNRS)- this item is anchored to pain intensity "right now" on a scale from 0(no pain)-10 (worst pain imaginable)

  Pain intensity rating in the ED at 1-hour post-study drug administration

Secondary Outcomes (1)

• Pain Intensity at Follow-Up

  Pain Intensity at 1-week post-ED Discharge

Study Arms (2)

Experimental Arm

EXPERIMENTAL

Participants will be assigned to receive a single dose of IV ketamine (0.3 mg.kg) + midazolam

Drug: Ketamine; Drug: Midazolam

Active Placebo Arm

ACTIVE COMPARATOR

Participants will be assigned to receive a single dose of IV placebo + midazolam

Drug: Midazolam; Drug: Placebo

Interventions

Ketamine DRUG

Ketamine is a medication approved by the US Food and Drug Administration (FDA) for anesthesia, sedation, and post-surgical pain treatment. It is not approved for emergency patients complaining of pain but is often used "off-label." Ketamine may be useful for acute pain management and in treatment of depressed mood. The purpose of this study is to determine whether a single low dose of ketamine can relieve pain and reduce negative mood for 2 weeks after emergency department (ED) treatment.

Experimental Arm

Midazolam DRUG

In this study, all patients will also receive midazolam. Midazolam is a sedative that typically makes people feel relaxed and is intended to increase comfort with ketamine and reduce anxiety.

Active Placebo Arm; Experimental Arm

Placebo DRUG

In this study, patients in the active comparator group will receive midazolam first, then placebo. A placebo is an inactive solution that looks like the study drug, but contains no active ingredients.

Active Placebo Arm

Eligibility Criteria

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

You may qualify if:

• Adults between the ages of 18-65
• A chief complaint of painful condition (pain score ≥ 5 on the numeric rating scale \[NRS\] from 0-10 with anchors of 0 = "no pain" and 10 = "worst pain imaginable")
• Expected to be in the ED for at least 2 hours

You may not qualify if:

• Non-English speaking
• Not medically suitable for ketamine per treating MD (e.g. medical condition where ketamine is contraindicated); ketamine or midazolam may be unsafe (e.g., known sensitivity, glaucoma, or other concerns)
• Not alert and oriented
• Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by treating team
• Seeking treatment due to a mental health or substance use disorder
• History of chronic opioid use
• Prescribed opioid use within the past 24 hours
• Any use of recreational narcotics throughout lifetime
• Sensitivity or allergy or intolerance to ketamine, opioids, and/or benzodiazepines
• Weight \> 170kg (375 lbs)
• Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure disorder, etc.)
• Pregnancy
• Prisoner

Sponsors & Collaborators

• Maria Pacella: lead
• University of Pittsburgh Physicians: collaborator

MeSH Terms

Conditions

Acute Pain; Depression

Interventions

Ketamine; Midazolam

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Maria L Pacella, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be randomly assigned to either the experimental condition (ketamine + midazolam) or the active control condition (placebo + midazolam)

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 19, 2018
• Study Start: December 1, 2019
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: February 11, 2020

Record last verified: 2020-02