Intravenous Acetaminophen and Ketorolac for Pain Management During Extracorporeal Shockwave Lithotripsy

NCT07368738 | Enrolling By Invitation Phase 4

• 1 other identifier: 6191
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

acetaminophen; ketorolac; extracorporeal shockwave lithotripsy; intravenous; pain

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  During the procedure

• Rate of Adverse Medication Effects

  During the procedure

Study Arms (2)

Opioid

ACTIVE COMPARATOR

Drug: IV midazolam; Drug: IV fentanyl

Non-Opioid

EXPERIMENTAL

Drug: IV midazolam; Drug: IV acetaminophen; Drug: IV ketorolac

Interventions

IV midazolam DRUG

1-2 mg

Non-Opioid; Opioid

IV fentanyl DRUG

25-300 mcg

Opioid

IV acetaminophen DRUG

1 g

Non-Opioid

IV ketorolac DRUG

30 mg

Non-Opioid

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 19 years
• Undergoing ESWL
• Able to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Horizon Health Network: lead

Study Sites (1)

St. Joseph's Hospital

Saint John, New Brunswick, E2L 3L6, Canada

Location

MeSH Terms

Conditions

Pain

Interventions

Midazolam; Fentanyl; Acetaminophen; Ketorolac

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles

Study Officials

• Thomas F Whelan, MD, FRCSC

  Department of Urology - Horizon Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)