A Phase 4 interventional study of IV midazolam and IV fentanyl in Extracorporeal Shockwave Lithotripsy, sponsored by Horizon Health Network. Enrolling by invitation at 1 site in Canada. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Horizon Health Network · Phase 4, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
Drug: IV midazolam · Drug: IV fentanyl
Drug: IV midazolam · Drug: IV acetaminophen · Drug: IV ketorolac
1-2 mg
25-300 mcg
1 g
30 mg
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).
Time frame: Before the procedure, and 30 minutes after the procedure
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
Hypotension, oxygen desaturations, nausea/vomiting
Time frame: During the procedure
Plan to share: No
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Horizon Health Network