NCT06395428 Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department
| NCT ID | NCT06395428 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Western Michigan University School of Medicine |
| Condition | Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-07-09 |
| Primary Completion | 2025-04-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 75 participants in total. It began in 2024-07-09 with a primary completion date of 2025-04-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Jessica McCoy, MD
PRINCIPAL INVESTIGATOR
Western Michigan University Homer Stryker M.D. School of Medicine
Frequently Asked Questions
Who can join the NCT06395428 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06395428 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06395428 currently recruiting?
Yes, NCT06395428 is actively recruiting participants. Contact the research team at jessica.mccoy@wmed.edu for enrollment information.
Where is the NCT06395428 trial being conducted?
This trial is being conducted at Kalamazoo, United States.
Who is sponsoring the NCT06395428 clinical trial?
NCT06395428 is sponsored by Western Michigan University School of Medicine. The principal investigator is Jessica McCoy, MD at Western Michigan University Homer Stryker M.D. School of Medicine. The trial plans to enroll 75 participants.