Acetaminophen + Ketorolac for Pain Management During Lithotripsy

TF
Overseen ByThomas F Whelan, MD, FRCSC
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

TF

Thomas F Whelan, MD, FRCSC

Principal Investigator

Department of Urology - Horizon Health Network

Are You a Good Fit for This Trial?

This trial is for adults aged 19 or older who can give informed consent and are undergoing extracorporeal shockwave lithotripsy (ESWL) to manage chronic persistent surgical pain.

Inclusion Criteria

I am 19 years old or older.
I am undergoing shock wave therapy for kidney stones.
I can understand and agree to the study's procedures and risks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a non-opioid regimen (IV midazolam, acetaminophen, and ketorolac) or an opioid-based regimen (IV midazolam and fentanyl) during ESWL

1 day
1 visit (in-person)

Follow-up

Participants are monitored for pain control and adverse effects after the procedure

1 day
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Intravenous Acetaminophen and Ketorolac

Trial Overview

The study compares a non-opioid pain management regimen (IV midazolam, IV acetaminophen, IV ketorolac) with a standard opioid-based one (IV midazolam, IV fentanyl) during ESWL. Participants will be randomly assigned to either group and their pain levels will be assessed before and after the procedure.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Non-OpioidExperimental Treatment3 Interventions
Group II: OpioidActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Horizon Health Network

Lead Sponsor

Trials
30
Recruited
16,800+