drugset / Trial / NCT07368738

Intravenous Acetaminophen and Ketorolac for Pain Management During Extracorporeal Shockwave Lithotripsy

NCT07368738

Phase 4 Enrolling by invitation 266 enrolled Horizon Health Network
RandomizedParallel-groupSingle-blindSupportive care

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.

Timeline

Start
2026-04
Primary completion
2027-04
Completion
2027-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 1 g Intravenous
Comparator Fentanyl Other / unclassified 25 ug Intravenous
Comparator Fentanyl Other / unclassified 300 ug Intravenous
Subject Ketorolac Other / unclassified 30 mg Intravenous
Background Midazolam Small molecule 1 mg Intravenous
Background Midazolam Small molecule 2 mg Intravenous

Indications

No indication recorded.