Extracorporeal Shockwave LithotripsyPhase 4NCT07368738
Intravenous Acetaminophen and Ketorolac for Pain Management During Extracorporeal Shockwave Lithotripsy
A Phase 4 study testing IV midazolam, IV fentanyl and IV acetaminophen in people with Extracorporeal Shockwave Lithotripsy, run by Horizon Health Network at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Extracorporeal Shockwave Lithotripsy
- What is being tested?
- IV midazolam, IV fentanyl and IV acetaminophen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2026to Apr 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 19 years
- Undergoing ESWL
- Able to provide informed consent
Who cannot join
- 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
Show all 10Show fewer
- Concurrent anticoagulant prescription
- Liver disease
- Elevated liver function tests
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Intravenous Acetaminophen and Ketorolac for Pain Management During Extracorporeal Shockwave Lithotripsy: A Quasi-Randomized Controlled 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?
Read more
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.
Read the detailed description
Extracorporeal shockwave lithotripsy (ESWL) is a common outpatient treatment for renal and ureteric stones, but the shockwaves can be painful and often require intra-procedure sedation and analgesia to improve comfort and allow delivery of an adequate number of shockwaves at therapeutic energy settings. Opioid-based regimens are widely used for ESWL because they are familiar, titratable, and effective; however, peri-procedural opioid exposure is increasingly scrutinized in the context of Canada's opioid crisis.
This study is a prospective quasi-randomized controlled trial in adults undergoing ESWL at St. Joseph's Hospital in Saint John, New Brunswick. The trial compares an opioid-sparing, multimodal regimen (intravenous midazolam, acetaminophen, and ketorolac) with a standard opioid-based regimen (intravenous midazolam and fentanyl). The primary objective is to evaluate the effectiveness of the non-opioid multimodal regimen on procedural pain compared with the standard opioid-based regimen. Secondary objectives include comparing shockwave tolerability and the adverse effect profile between regimens.
Participants are randomly allocated to a regimen and remain blinded to which regimen they receive. Sedation/analgesia is administered intravenously according to the assigned pathway, with midazolam titrated to achieve moderate sedation and analgesia provided via fentanyl (opioid arm) or a multimodal combination of ketorolac and acetaminophen (non-opioid arm).
Pain is measured using a 0-10 numeric rating scale (NRS). The NRS is administered before ESWL and 30 minutes after ESWL. Procedure tolerability is assessed using proxy measures recorded during ESWL (total shockwaves delivered and highest energy level achieved). Adverse medication effects recorded include hypotension, oxygen desaturations, and nausea/vomiting.
The overarching goal is to determine whether an opioid-sparing ESWL pathway can provide equal or superior pain control while maintaining comparable procedural tolerability and safety, supporting routine adoption of non-opioid multimodal analgesia when feasible.
- Conditions
- Extracorporeal Shockwave Lithotripsy
- Being tested
- IV midazolam, IV fentanyl, IV acetaminophen, IV ketorolac
- Keywords
- acetaminophen, ketorolac, extracorporeal shockwave lithotripsy, intravenous, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV midazolamDrug
1-2 mg
IV fentanylDrug
25-300 mcg
IV acetaminophenDrug
1 g
IV ketorolacDrug
30 mg
| Study group | Role | What they receive |
|---|---|---|
| Opioid | Active comparator | Not described Receives: Drug: IV midazolam; Drug: IV fentanyl |
| Non-Opioid | Experimental | Not described Receives: Drug: IV midazolam; Drug: IV acetaminophen; Drug: IV ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain as Assessed by the NRS
The numeric rating scale (NRS) will be used to quantify pain. Scores range from 0 (no pain) to 10 (worst pain).
Measured: Before the procedure, and 30 minutes after the procedure
Secondary outcomes (2)
Procedure Tolerability as Assessed by Total Number of Shockwaves Delivered and Highest Energy Level Achieved
Measured: During the procedure
Rate of Adverse Medication Effects
Hypotension, oxygen desaturations, nausea/vomiting
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Shockwave LithotripsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horizon Health Network
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sufyan Faridi, Horizon Health Network
- Investigators
- Thomas F Whelan, MD, FRCSC, Principal investigator, Department of Urology - Horizon Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368738
- Sponsor's protocol ID
- 6191
- Status last verified
- Apr 2026
- First submitted
- 20 Jan 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Acetaminophen and Ketorolac for Pain Management During Extracorporeal Shockwave Lithotripsy: A Quasi-Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07368738
- Acronym / sponsor ID
- 6191
- Conditions
- Extracorporeal Shockwave Lithotripsy
- Keywords
- acetaminophen, ketorolac, extracorporeal shockwave lithotripsy, intravenous, pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Horizon Health NetworkUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Extracorporeal shockwave lithotripsy (ESWL) is a common outpatient treatment for renal and ureteric stones, but the shockwaves can be painful and often require intra-procedure sedation and analgesia to improve comfort and allow delivery of an adequate number of shockwaves at therapeutic energy settings. Opioid-based regimens are widely used for ESWL because they are familiar, titratable, and effective; however, peri-procedural opioid exposure is increasingly scrutinized in the context of Canada's opioid crisis.
This study is a prospective quasi-randomized controlled trial in adults undergoing ESWL at St. Joseph's Hospital in Saint John, New Brunswick. The trial compares an opioid-sparing, multimodal regimen (intravenous midazolam, acetaminophen, and ketorolac) with a standard opioid-based regimen (intravenous midazolam and fentanyl). The primary objective is to evaluate the effectiveness of the non-opioid multimodal regimen on procedural pain compared with the standard opioid-based regimen. Secondary objectives include comparing shockwave tolerability and the adverse effect profile between regimens.
Participants are randomly allocated to a regimen and remain blinded to which regimen they receive. Sedation/analgesia is administered intravenously according to the assigned pathway, with midazolam titrated to achieve moderate sedation and analgesia provided via fentanyl (opioid arm) or a multimodal combination of ketorolac and acetaminophen (non-opioid arm).
Pain is measured using a 0-10 numeric rating scale (NRS). The NRS is administered before ESWL and 30 minutes after ESWL. Procedure tolerability is assessed using proxy measures recorded during ESWL (total shockwaves delivered and highest energy level achieved). Adverse medication effects recorded include hypotension, oxygen desaturations, and nausea/vomiting.
The overarching goal is to determine whether an opioid-sparing ESWL pathway can provide equal or superior pain control while maintaining comparable procedural tolerability and safety, supporting routine adoption of non-opioid multimodal analgesia when feasible.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Opioid | Active comparator | Drug: IV midazolam, Drug: IV fentanyl |
| Non-Opioid | Experimental | Drug: IV midazolam, Drug: IV acetaminophen, Drug: IV ketorolac |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 19 years
- Undergoing ESWL
- Able to provide informed consent
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV midazolam1-2 mg | Drug | Non-Opioid, Opioid |
| IV fentanyl25-300 mcg | Drug | Opioid |
| IV acetaminophen1 g | Drug | Non-Opioid |
| IV ketorolac30 mg | Drug | Non-Opioid |
Primary outcome
Pain as Assessed by the NRS
Time frame: Before the procedure, and 30 minutes after the procedure
The numeric rating scale (NRS) will be used to quantify pain. Scores range from 0 (no pain) to 10 (worst pain).
2 secondary outcomes
Procedure Tolerability as Assessed by Total Number of Shockwaves Delivered and Highest Energy Level Achieved
Time frame: During the procedure
Rate of Adverse Medication Effects
Time frame: During the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas F Whelan, MD, FRCSC principal investigator
Department of Urology - Horizon Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV midazolam, IV fentanyl and IV acetaminophen in people with Extracorporeal Shockwave Lithotripsy, run by Horizon Health Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain as Assessed by the NRS (time frame: Before the procedure, and 30 minutes after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.