Intravenous Acetaminophen and Ketorolac for Pain Management During Extracorporeal Shockwave Lithotripsy

Enrolling by invitation · Phase 4

Conditions studied: Extracorporeal Shockwave Lithotripsy

In brief

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.

Key facts

Study ID

NCT07368738

Run by

Horizon Health Network

People needed

266

Starts

2026-04-01

Expected to finish

2027-04-01

Last updated by the study team

2026-04-13

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 19 years
• Undergoing ESWL
• Able to provide informed consent

You may not qualify if…

• Prior ESWL treatment in the past six months
• Narcotic use in the last 48 hours
• Allergy to midazolam, fentanyl, acetaminophen, or ketorolac
• Chronic kidney disease
• Solitary kidney
• Active peptic ulcer disease
• Concurrent anticoagulant prescription
• Liver disease
• Elevated liver function tests
• Pregnancy

Where it is running

• St. Joseph's Hospital — Saint John, New Brunswick, Canada

Full record on ClinicalTrials.gov

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