NCT06395428 · Western Michigan University School of Medicine
Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department
What this study is about
Single center, where neither patients nor doctors know which treatment is given, randomly assigned, 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.
View original scientific description
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.
Interventions
DRUG
Haloperidol
Intramuscular injection of drug
DRUG
Ketorolac Tromethamine
Intramuscular injection of drug
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Kalamazoo, Michigan
Collaborators
Bronson Methodist Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 10, 2024 · Source of record for eligibility and locations