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

July 9, 2024 updated by: Western Michigan University School of Medicine
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Haloperidol
Haloperidol 5 mg IM haloperidol
Drug: Haloperidol
Intramuscular injection of drug
Other Names:
  • Haldol
Active Comparator: Ketoralac
Ketoralac 30 mg IM
Drug: Ketorolac Tromethamine
Intramuscular injection of drug
Other Names:
  • Toradol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30, 60, and 90 minutes after drug administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours
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.
30, 60, and 90 minutes after drug administration
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.
24 hours after enrollment up to 1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Michigan University School of Medicine

Collaborators

Bronson Methodist Hospital

Investigators

  • Principal Investigator: Jessica McCoy, MD, Western Michigan University Homer Stryker M.D. School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 9, 2024

Primary Completion (Estimated)

April 15, 2025

Study Completion (Estimated)

April 15, 2027

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

April 29, 2024

First Posted (Actual)

May 2, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 9, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WMed-2024-1032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The subject's info collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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