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NOT YET RECRUITING
NCT07368738
PHASE4

Intravenous Acetaminophen and Ketorolac for Pain Management During Extracorporeal Shockwave Lithotripsy

Sponsor: Horizon Health Network

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.

Official title: Intravenous Acetaminophen and Ketorolac for Pain Management During Extracorporeal Shockwave Lithotripsy: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

266

Start Date

2026-03

Completion Date

2027-03

Last Updated

2026-01-28

Healthy Volunteers

No

Interventions

DRUG

IV midazolam

1-2 mg

DRUG

IV fentanyl

25-300 mcg

DRUG

IV acetaminophen

1 g

DRUG

IV ketorolac

30 mg

Locations (1)

St. Joseph's Hospital

Saint John, New Brunswick, Canada