Last reviewed · How we verify
NCT07368738
Intravenous Acetaminophen and Ketorolac for Pain Management During Extracorporeal Shockwave Lithotripsy: A Quasi-Randomized Controlled Trial
Phase 4 trial testing IV midazolam in Extracorporeal Shockwave Lithotripsy in 266 participants. Enrolling by invitation.
1 April 2027
Quick facts
| Lead sponsor | Horizon Health Network |
|---|---|
| Phase | Phase 4 |
| Status | ENROLLING BY INVITATION |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 266 |
| Start date | 1 April 2026 |
| Primary completion | 1 April 2027 |
| Estimated completion | 1 April 2027 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- IV midazolam — full drug profile →
- IV fentanyl — full drug profile →
- IV acetaminophen — full drug profile →
- IV ketorolac — full drug profile →
Conditions studied
- Extracorporeal Shockwave Lithotripsy — all drugs for Extracorporeal Shockwave Lithotripsy →
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.
-
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).
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.
Verify or expand the search:
- PubMed search for NCT07368738
- Europe PMC full search
- ASCO Meeting Library
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07368738 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Horizon Health Network
- Last refreshed: 7 April 2026
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.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing