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

NCT06395428 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: WMed-2024-1032
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain; Chronic Pain

Keywords

Haloperidol; Chronic Pain; Back Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  Mean change in visual analog scale (VAS) of self-rated nausea severity

  30, 60, and 90 minutes after drug administration

Secondary Outcomes (3)

• Length of stay after enrollment

  24 hours

• Need for rescue medications

  30, 60, and 90 minutes after drug administration

• Patient Satisfaction

  24 hours after enrollment up to 1 week

Study Arms (2)

Haloperidol

EXPERIMENTAL

Haloperidol 5 mg IM haloperidol

Drug: Haloperidol

Ketoralac

ACTIVE COMPARATOR

Ketoralac 30 mg IM

Drug: Ketorolac Tromethamine

Interventions

Haloperidol DRUG

Intramuscular injection of drug

Also known as: Haldol

Haloperidol

Ketorolac Tromethamine DRUG

Intramuscular injection of drug

Also known as: Toradol

Ketoralac

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Michigan University School of Medicine: lead
• Bronson Methodist Hospital: collaborator

Study Sites (1)

Bronson Methodist Hospital

Kalamazoo, Michigan, 49007, United States

RECRUITING

Related Publications (17)

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  PMID: 28376873 RESULT

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  PMID: 26802501 RESULT

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  PMID: 21119516 RESULT

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  PMID: 29709398 RESULT

• Rech MA, Griggs C, Lovett S, Motov S. Acute pain management in the Emergency Department: Use of multimodal and non-opioid analgesic treatment strategies. Am J Emerg Med. 2022 Aug;58:57-65. doi: 10.1016/j.ajem.2022.05.022. Epub 2022 May 22.

  PMID: 35636044 RESULT

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Related Links

• Haloperidol by Patriot Pharmaceuticals LLC / Johnson \& Johnson Research \& Development, LLC / Janssen Pharmaceutica NV / Janssen Pharmaceutica, NV HALOPERIDOL injection.

MeSH Terms

Conditions

Back Pain; Chronic Pain

Interventions

Haloperidol; Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jessica McCoy, MD

  Western Michigan University Homer Stryker M.D. School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica McCoy, MD

CONTACT

269-337-6600; jessica.mccoy@wmed.edu

Katharine Mitchell, MA

CONTACT

269-341-8364; mitckath@bronsonhg.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: May 2, 2024
• Study Start: July 9, 2024
• Primary Completion: April 15, 2025
• Study Completion (Estimated): April 15, 2027
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)