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Could acetaminophen replace opioids for kidney stone pain?

NCT ID NCT07368738

Symptom relief Sponsor: Horizon Health Network Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a combination of IV acetaminophen and ketorolac can manage pain during kidney stone shockwave treatment as well as the standard opioid-based regimen. About 266 adults will be randomly assigned to receive either the non-opioid or opioid pain medicines. The goal is to see if the non-opioid approach provides similar pain control with fewer side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
acetaminophen and ketorolac
What this could lead to
If it works, this could offer a safer, non-opioid option for managing pain during kidney stone procedures.
What could go wrong
This is a small, early-phase trial, so results may not apply to all patients. The non-opioid regimen might not control pain as well as opioids.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 266 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 19 years * Undergoing ESWL * Able to provide informed consent Exclusion Criteria: * Prior ESWL treatment in the past six months * Narcotic use in the last 48 hours * Allergy to midazolam, fentanyl, acetaminophen, or ketorolac * Chronic kidney disease * Solitary kidney * Active peptic ulcer disease * Concurrent anticoagulant prescription * Liver disease * Elevated liver function tests * Pregnancy

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Conditions

The condition(s) this trial relates to.

nephrolithiasis Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Extracorporeal shockwave lithotripsy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • St. Joseph's Hospital

    Saint John, New Brunswick, E2L 3L6, Canada

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