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Clinical Trials in Canada / NCT07368738
Enrolling by invitation Phase 4

Intravenous Acetaminophen and Ketorolac for Pain Management During Extracorporeal Shockwave Lithotripsy

NCT07368738 · tracked via the Priya Life Science Canada tracker
Phase
Phase 4
Started
2026-04
Last updated
2026-04-13

Condition(s) studied

Extracorporeal Shockwave Lithotripsy

Investigational drug(s) / intervention(s)

IV midazolam →IV fentanyl →IV acetaminophen →IV ketorolac →

IV midazolam: 1-2 mg

IV fentanyl: 25-300 mcg

IV acetaminophen: 1 g

IV ketorolac: 30 mg

Study 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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age ≥ 19 years * Undergoing ESWL * Able to provide informed consent Exclusion Criteria: * 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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
St. Joseph's Hospital Saint John New Brunswick

More Horizon Health Network trials in Canada

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07368738 on ClinicalTrials.gov ↗ ← All trials in Canada