Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency De… (NCT06395428) | Clinical Trial Compass
RecruitingPhase 4
Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department
United States75 participantsStarted 2024-07-09
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Visual Analog Scale (VAS)
Timeframe: 30, 60, and 90 minutes after drug administration
Trial details
NCT IDNCT06395428
SponsorWestern Michigan University School of Medicine