Acetaminophen + Ketorolac for Pain Management During Lithotripsy
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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either a non-opioid regimen (IV midazolam, acetaminophen, and ketorolac) or an opioid-based regimen (IV midazolam and fentanyl) during ESWL
Follow-up
Participants are monitored for pain control and adverse effects after the procedure
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Horizon Health Network
Lead Sponsor
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