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

Phase 2

Withdrawn

• Conditions: Acute Pain; Depression
• Interventions: Drug: Ketamine; Drug: Placebo; Drug: Midazolam

• Registration Number: NCT03436121
• Lead Sponsor: Maria Pacella

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).

Detailed Description

The investigators will enroll 120 medically stable adult patients who present to two Emergency Departments with a chief complaint of acute pain.

The investigators will randomly assign subjects using a blocked randomization schedule to either: 1) a single dose of IV ketamine (0.3 mg.kg) + midazolam, or 2) placebo + midazolam. ED providers and patients will be blind to treatment allocation.

All participants will complete measures of pain and mood scores every 30 minutes, and the investigators will record any analgesics administered in the ED until discharge. At 7-days and 14-days post- discharge, the investigators will measure summary reports of pain severity, mood, and analgesic medication used.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-19
• Study Start: 2019-12
• Status Verified: 2020-02
• Primary Completion: 2020-02-05
• Study Completion: 2020-02-05
• Last Update Submitted: 2020-02-07
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Adults between the ages of 18-65
2. 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")
3. Expected to be in the ED for at least 2 hours

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Exclusion Criteria

1. Non-English speaking
2. 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)
3. Not alert and oriented
4. Active psychosis, self-injury, suicidal/homicidal intentions on initial evaluation by treating team
5. Seeking treatment due to a mental health or substance use disorder
6. History of chronic opioid use
7. Prescribed opioid use within the past 24 hours
8. Any use of recreational narcotics throughout lifetime
9. Sensitivity or allergy or intolerance to ketamine, opioids, and/or benzodiazepines
10. Weight > 170kg (375 lbs)
11. Current neurological disease (e.g., multiple sclerosis, stroke, brain tumor, seizure disorder, etc.)
12. Pregnancy
13. Prisoner

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Placebo Arm	Placebo	Participants will be assigned to receive a single dose of IV placebo + midazolam
Experimental Arm	Midazolam	Participants will be assigned to receive a single dose of IV ketamine (0.3 mg.kg) + midazolam
Experimental Arm	Ketamine	Participants will be assigned to receive a single dose of IV ketamine (0.3 mg.kg) + midazolam
Active Placebo Arm	Midazolam	Participants will be assigned to receive a single dose of IV placebo + midazolam

Primary Outcome Measures

Name	Time	Method
Pain Intensity in the ED	Pain intensity rating in the ED at 1-hour post-study drug administration	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)

Secondary Outcome Measures

Name	Time	Method
Pain Intensity at Follow-Up	Pain Intensity at 1-week post-ED Discharge	Pain Numeric Rating Scale (PNRS): this item is anchored to pain intensity within the past 7-days on a scale from 0 (no pain) to 10 (worst pain imaginable)