Clinical trial NCT06395428: Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department
Official title: Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Back Pain
Chronic Pain
Keywords: Haloperidol
Chronic Pain
Back Pain
Lead sponsor: Western Michigan University School of Medicine
Sponsor class: OTHER
Collaborators: name: Bronson Methodist Hospital
First posted: 2024-05-02
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-center prospective randomized double-blinded non-inferiority trial with potential assessment of superiority comparing haloperidol to ketorolac for the treatment of back pain.
Primary purpose: TREATMENT

Brief summary: Single center, double-blind, randomized, controlled trial in patients who present to the emergency department (ED) with a chief complaint of back pain. A total of 150 patients age 18-65 presenting to the emergency department with chief complaint of backpain will be enrolled from April 2024 - April 2025. Patients will be randomized and symptom levels will be recorded at 30, 60, 90, minutes. Follow-up will be performed by telephone at 24 hours.


Eligibility criteria: Inclusion Criteria:

* Age 18 - 65 years old
* Presenting to the Bronson ED with a chief complaint of acute, non-traumatic back pain
* VAS score \>5 cm

Exclusion Criteria:

* Back pain due to traumatic injury
* Experiencing saddle anesthesia
* Has bowel or bladder dysfunction
* Has an abnormal neurological exam
* Requires imaging in ED
* Has a Glascow coma score \<15
* Has one or more abnormal vital signs:

HR\>120, SBP\>180 or \<90, temperature \>38°, O2 saturation\<92%

* Has an allergy to ketorolac or haloperidol
* Has a known diagnosis of Lewy Body Dementia
* Has a known diagnosis of glaucoma.
* Is known to be pregnant or breastfeeding
* Is a prisoner or ward of the state
* Is unable to consent for themselves/ non-english speaking
* In the opinion of the attending physician or investigator the patient should not participate in the research

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: 30, 60, and 90 minutes after drug administration
Secondary outcomes:
measure: Length of stay after enrollment
timeFrame: 24 hours
measure: Need for rescue medications
timeFrame: 30, 60, and 90 minutes after drug administration
measure: Patient Satisfaction
timeFrame: 24 hours after enrollment up to 1 week
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Bronson Methodist Hospital
state: Michigan
Study officials:
affiliation: Western Michigan University Homer Stryker M.D. School of Medicine
name: Jessica McCoy, MD
role: PRINCIPAL_INVESTIGATOR
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