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

Primary Purpose

Acute Pain, Depression

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Ketamine

Midazolam

Placebo

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental Arm

Active Placebo Arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Pain Intensity at Follow-Up

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)

Full Information

NCT ID

NCT03436121

First Posted

January 31, 2018

Last Updated

February 7, 2020

Sponsor

Maria Pacella

Collaborators

University of Pittsburgh Physicians

1. Study Identification

Unique Protocol Identification Number

NCT03436121

Brief Title

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

Official Title

Single-dose Ketamine to Reduce Pain Severity, Depressive Symptoms and the Need for Opiates Both During and After Emergency Department Care

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Withdrawn

Why Stopped

Ketamine shortage during the funding period of the trial

Study Start Date

December 2019 (Anticipated)

Primary Completion Date

February 5, 2020 (Actual)

Study Completion Date

February 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Maria Pacella

Collaborators

University of Pittsburgh Physicians

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Pain, Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Arm

Arm Type

Experimental

Arm Description

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

Arm Title

Active Placebo Arm

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Midazolam

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Pain Intensity in the ED

Description

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)

Time Frame

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

Secondary Outcome Measure Information:

Title

Pain Intensity at Follow-Up

Description

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)

Time Frame

Pain Intensity at 1-week post-ED Discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maria L Pacella, PhD

Organizational Affiliation

University of Pittsburgh

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

There is no plan in place yet because it is undecided whether the investigators will need to share the data with additional investigators/researchers not listed on the protocol.

Learn more about this trial

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

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