Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department
Purpose
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.
Conditions
- Back Pain
- Chronic Pain
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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
- Masking
- Triple (Participant, Care Provider, Investigator)
- Masking Description
- Treatment allocations will be revealed only after study completion, unless there is concern for a serious adverse event in which case treatment team and patient will be unblinded. Interim analysis will be performed at 34 participants to evaluate for effectiveness and power
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Haloperidol |
Haloperidol 5 mg IM haloperidol |
|
|
Active Comparator Ketoralac |
Ketoralac 30 mg IM |
|
Recruiting Locations
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
Kalamazoo, Michigan 49007
More Details
- Status
- Recruiting
- Sponsor
- Western Michigan University School of Medicine