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

Last updated: July 9, 2024
Sponsor: Western Michigan University School of Medicine
Overall Status: Active - Recruiting

Phase

4

Condition

Chronic Pain

Pain

Treatment

Ketorolac Tromethamine

Haloperidol

Clinical Study ID

NCT06395428
WMed-2024-1032
  • Ages 18-65
  • All Genders

Study 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

Inclusion Criteria:

  • Age 18 - 65 years old

  • Presenting to the Bronson ED with a chief complaint of acute, non-traumatic backpain

  • VAS score >5 cm

Exclusion

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 notparticipate in the research

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Ketorolac Tromethamine
Phase: 4
Study Start date:
July 09, 2024
Estimated Completion Date:
April 15, 2027

Connect with a study center

  • Bronson Methodist Hospital

    Kalamazoo, Michigan 49007
    United States

    Active - Recruiting

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