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NCT Number: NCT06395428

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

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.

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Key information

Conditions

Back Pain Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Haloperidol

Drug

Intramuscular injection of drug

Other names: Haldol

Ketorolac Tromethamine

Drug

Intramuscular injection of drug

Other names: Toradol

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 30, 60, and 90 minutes after drug administration

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

Secondary outcomes

  1. Length of stay after enrollment

    Time frame: 24 hours

    Mean length of stay in minutes between the 2 groups will be assessed with a student's t test to assess for significant difference between groups

  2. Need for rescue medications

    Time frame: 30, 60, and 90 minutes after drug administration

    Need for rescue medications will be a Boolean variable recorded in redcaps that will be qualitatively assessed to compare the number of patients in each group requiring rescue medication.

  3. Patient Satisfaction

    Time frame: 24 hours after enrollment up to 1 week

    This will be assessed based on the follow-up question "would you receive this treatment again?" on the follow-up phone call. Number of patients in each group that answer yes to this question will be qualitatively discussed in the results.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica McCoy, MD

CONTACT

[email protected]

269-337-6600

Katharine Mitchell, MA

CONTACT

[email protected]

269-341-8364

Sponsors and collaborators

Lead sponsor

Western Michigan University School of Medicine

Other

Collaborators

  • Bronson Methodist Hospital

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
May 2, 2024
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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