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Intravenous Acetaminophen and Ketorolac for Pain Management During Extracorporeal Shockwave Lithotripsy

NCT07368738 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2026-04-13

No results posted yet for this 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.

Conditions

  • Extracorporeal Shockwave Lithotripsy

Interventions

DRUG

IV midazolam

1-2 mg

DRUG

IV fentanyl

25-300 mcg

DRUG

IV acetaminophen

1 g

DRUG

IV ketorolac

30 mg

Sponsors & Collaborators

  • Horizon Health Network

    lead OTHER

Principal Investigators

  • Thomas F Whelan, MD, FRCSC · Department of Urology - Horizon Health Network

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07368738 on ClinicalTrials.gov