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

Phase 4

Recruiting

• Conditions: Chronic Pain; Back Pain
• Interventions: Drug: Haloperidol; Drug: Ketorolac Tromethamine

• Registration Number: NCT06395428
• Lead Sponsor: Western Michigan University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-02
• Status Verified: 2024-07
• Study Start: 2024-07-09
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2025-04-15
• Study Completion: 2027-04-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Haloperidol	Haloperidol	Haloperidol 5 mg IM haloperidol
Ketoralac	Ketorolac Tromethamine	Ketoralac 30 mg IM

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	30, 60, and 90 minutes after drug administration	Mean change in visual analog scale (VAS) of self-rated nausea severity

Secondary Outcome Measures

Name	Time	Method
Length of stay after enrollment	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
Patient Satisfaction	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.
Need for rescue medications	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.

Trial Locations

Locations (1)

Bronson Methodist Hospital; 🇺🇸 Kalamazoo, Michigan, United States