Back Pain, Chronic Pain
Conditions
Keywords
Haloperidol, Chronic Pain, Back Pain
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.
Interventions
DRUGHaloperidol
Intramuscular injection of drug
DRUGKetorolac Tromethamine
Intramuscular injection of drug
Sponsors
Bronson Methodist Hospital
Western Michigan University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Treatment allocations will be revealed only after study completion, unless there is concern for a serious adverse event in which case treatment team and patient will be unblinded. Interim analysis will be performed at 34 participants to evaluate for effectiveness and power
Intervention model description
This is a single-center prospective randomized double-blinded non-inferiority trial with potential assessment of superiority comparing haloperidol to ketorolac for the treatment of back pain.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
Countries
United States
Contacts
Primary ContactJessica McCoy, MD
Backup ContactKatharine Mitchell, MA
Outcome results
None listed