Phase 3
N=105
Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery.
Nephrolithiasis
Bottom Line
View on ClinicalTrials.gov: NCT03584373 ↗Enrolled (actual)
105
Serious AEs
11.4%
Results posted
Dec 2023
Primary outcome: Primary: Satisfaction With Pain Relief — 8.70; 8.85 score on a scale — p=0.70
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ketorolac Oral Tablet [Toradol] (Drug); Acetaminophen (Drug); Oxycodone Acetaminophen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Satisfaction With Pain Relief |
8.70; 8.85 | 0.70 |
| PRIMARY Current Pain Intensity Level |
1.14; 1.37 | 0.58 |
| PRIMARY Peak Pain Intensity Level |
5.61; 7.52 | 0.006 sig |
| PRIMARY Average Pain Intensity Level |
3.34; 4.50 | 0.04 sig |
| PRIMARY Perception of an Acceptable Pain Intensity Level |
2.73; 3.28 | 0.33 |
| SECONDARY Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery |
0.63; 0.58 | 0.47 |
| SECONDARY Rates of Constipation |
11; 17 | — |
Summary
There are two options for postoperative pain management: opioid and non-opioid analgesia. Pain outcomes will be compared in patients undergoing ureteroscopy and percutaneous nephrolithotomy by randomly administering opioid and non-opioid analgesia.
Eligibility Criteria
Inclusion Criteria
- Men and Women age>18 years old
- Presence of renal or ureteral stones suitable for ureteroscopy or percutaneous nephrolithotomy.
- Uncomplicated ureteroscopy or percutaneous nephrolithotomy
Exclusion Criteria
- Pregnant/Breastfeeding/Possibly Pregnant Patients
- Pediatric Patients
- Sensitive or Allergic to Opioids, Ketorolac, or Acetaminophen
- Significant Renal Disease
- Peptic Ulcer Disease
- Chronic Pain and recovering opiate use
- Inability to complete questionnaires
- Non-mobile patients
- Patients on methadone
Data sourced from ClinicalTrials.gov (NCT03584373). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.