A Phase 4 interventional study of Haloperidol and Ketorolac Tromethamine in Back Pain and Chronic Pain, sponsored by Western Michigan University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-10.
Sponsored by Western Michigan University School of Medicine · Phase 4, Interventional, and Treatment
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.
2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.
This study's planned enrollment of 75 is above the median of 60 across 1,941 interventional studies indexed under Back Pain.
Browse Back Pain studies →Western Michigan University School of Medicine is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HR>120, SBP>180 or \<90, temperature >38°, O2 saturation\<92%
Haloperidol 5 mg IM haloperidol
Drug: Haloperidol
Ketoralac 30 mg IM
Drug: Ketorolac Tromethamine
Intramuscular injection of drug
Also known as: Haldol
Intramuscular injection of drug
Also known as: Toradol
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
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
Plan to share: No — 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.
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Western Michigan University School of Medicine