Status:
WITHDRAWN
Single-dose Ketamine for the Reduction of Pain and Depression in the Emergency Department
Lead Sponsor:
Maria Pacella
Collaborating Sponsors:
University of Pittsburgh Physicians
Conditions:
Acute Pain
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
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 analgesi...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03436121
Start Date
December 1 2019
End Date
February 5 2020
Last Update
February 11 2020
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