Recruiting

Haloperidol

Sponsor:

Western Michigan University School of Medicine

Code:

NCT06395428

Conditions

Back Pain

Chronic Pain

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Haloperidol

Ketorolac Tromethamine

Study Details

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

Study ID

NCT06395428

Start date

Jul 9, 2024

Status verified date

Jul, 2024

Completion date

Apr 15, 2027

Anticipated

Primary completion date

Apr 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Haloperidol

Haloperidol 5 mg IM haloperidol

active comparator: Ketoralac

Ketoralac 30 mg IM

Interventions

Haloperidol

Intramuscular injection of drug

Ketorolac Tromethamine

Intramuscular injection of drug

Primary outcome measure

  • Visual Analog Scale (VAS) [ Time Frame: 30, 60, and 90 minutes after drug administration ]

Central Contacts and Locations

Central contacts

Jessica McCoy, MD

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

Katharine Mitchell, MA

269-341-8364mitckath@bronsonhg.org

Locations

Bronson Methodist Hospital

Recruiting

Kalamazoo, Michigan, United States, 49007

Contacts

Jessica McCoy, MD

269-337-6600jessica.mccoy@med.wmich.edu

Katharine Mitchell, PhD

269-341-8364mitckath@bronsonhg.org

More Information

Sponsor

Western Michigan University School of Medicine

Last update posted

Jul 10, 2024

Last verified

Jul, 2024

Keywords

  • Haloperidol
  • Chronic Pain
  • Back Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western Michigan University School of Medicine on 2024-07-10.