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NCT07368738

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

ENROLLING BY INVITATION Phase 4 Last updated 7 April 2026
What this trial tests

Phase 4 trial testing IV midazolam in Extracorporeal Shockwave Lithotripsy in 266 participants. Enrolling by invitation.

Timeline
1 April 2026
Primary endpoint
1 April 2027
1 April 2027

Quick facts

Lead sponsorHorizon Health Network
PhasePhase 4
StatusENROLLING BY INVITATION
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposesupportive care
Enrollment266
Start date1 April 2026
Primary completion1 April 2027
Estimated completion1 April 2027
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Horizon Health Network

Who can join

19 and older, any sex, with Extracorporeal Shockwave Lithotripsy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Horizon Health Network trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07368738.

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