A Phase 2/3 interventional study of Ketamine and Midazolam in Acute Pain and Depression, sponsored by Maria Pacella. Withdrawn. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Maria Pacella · Phase 2/3, Interventional, and Treatment
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).
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.
Exclusion Criteria:
Participants will be assigned to receive a single dose of IV ketamine (0.3 mg.kg) + midazolam
Drug: Ketamine · Drug: Midazolam
Participants will be assigned to receive a single dose of IV placebo + midazolam
Drug: Midazolam · Drug: Placebo
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.
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.
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.
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)
Time frame: Pain intensity rating in the ED at 1-hour post-study drug administration
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)
Time frame: Pain Intensity at 1-week post-ED Discharge
No study locations are listed for this record.
Plan to share: Undecided — 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.
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Maria Pacella