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

Phase 4RecruitingNCT06395428

Western Michigan University School of Medicine75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Back Pain Chronic Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Visual Analog Scale (VAS)

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

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

Secondary Outcomes

Length of stay after enrollment

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

Time frame: 24 hours

Need for rescue medications

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.

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

Patient Satisfaction

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.

Time frame: 24 hours after enrollment up to 1 week

Central Contacts

Jessica McCoy, MD

CONTACT

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

Katharine Mitchell, MA