Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department

Western Michigan University School of Medicine

Status and phase: Enrolling; Phase 4

Conditions: Back Pain; Chronic Pain

Treatments: Drug: Haloperidol; Drug: Ketorolac Tromethamine

Study type: Interventional

Funder types: Other

Identifiers

NCT06395428

WMed-2024-1032

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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75 participants in 2 patient groups

Haloperidol

Experimental group

Description:

Haloperidol 5 mg IM haloperidol

Treatment:

Drug: Haloperidol

Ketoralac

Active Comparator group

Description:

Ketoralac 30 mg IM

Treatment:

Drug: Ketorolac Tromethamine

Sponsor of this trial

Lead Sponsor

Western Michigan University School of Medicine

Collaborating Sponsor

Bronson Methodist Hospital