Clinical Trial

Intravenous Acetaminophen and Ketorolac for Pain Management During Extracorporeal Shockwave Lithotripsy

Enrolling by Invitation Phase 4
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to learn if a non-opioid pain medicine regimen works as well as or better than a standard opioid-based regimen to manage pain during extracorporeal shockwave lithotripsy (ESWL) in adults. The main questions it aims to answer are: Does the non-opioid regimen lead to similar or better pain control during the procedure? Does the non-opioid regimen lead to similar or better procedure tolerability and side effect profile? The non-opioid regimen will use intravenous (IV) midazolam plus IV acetaminophen and IV ketorolac, and the standard opioid-based regimen will use IV midazolam plus IV fentanyl. Participants will be randomly assigned to receive one of the two medication regimens during ESWL, and asked to rate their pain before the procedure and 30 minutes after the procedure.
Protocol Amendment History 3 changes
critical Trial status changed: Not Yet Recruiting → Enrolling by Invitation 2026-04-14
notable Primary completion pushed: 2027-03 -> 2027-04 2026-04-14
minor Completion pushed: 2027-03 -> 2027-04 2026-04-14
Trial Details
NCT Number NCT07368738
Lead Sponsor Horizon Health Network
Conditions Extracorporeal Shockwave Lithotripsy
Enrollment 266 participants
Start Date 2026-04
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-04-13