A Phase 4 interventional study of Norco 5milligram-325milligram Tablet and Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED in Kidney Stone, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-11.
Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Treatment
The purpose of this research study is to compare how well two medications work to control post-operative pain.
This will be a randomized double blinded control trial with subjects randomized to either opioid group (Norco 5-325 milligram) or a non-opioid group (Ibuprofen 400 milligram). Subjects with a renal stones who are consented for a ureteroscopy will be eligible for the study. Subjects eligible for the study will have a discussion with the study team member about treatment options. Subjects can either elect not to be in the study and actively choose which treatment is preferable, or the subject can choose to enter the study and be randomized to one of these treatment arms. The ureteroscopy will be performed using standard of care instruments and techniques. No changes to operative technique will be performed for subjects in the study vs regular patients undergoing the same procedure. Post operatively; investigators plan to discharge all subjects home from the recovery unit. All subjects will be seen one week after surgery for follow up, questioner filling and stent removal.
598 studies on the registry are indexed under Kidney Calculi; 163 are open to participants now.
This study's enrollment of 22 is below the median of 90 across 461 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
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Exclusion Criteria:
This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Norco 5milligram-325milligram Tablet for postoperative pain after ureteroscopy with stent placement.
Drug: Norco 5milligram-325milligram Tablet
This group includes subjects with renal stones who are consented for a ureteroscopy. They will be randomized to Ibuprofen 400 milligram for postoperative pain after ureteroscopy with stent placement.
Drug: Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED
Designated coated 7 days supply of pain medication (Norco 5 milligram-325milligram Tablet) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times per day until the stent will be removed in clinic a week later.
Also known as: Opioid
Designated coated 7 days supply of pain medication (Ibuprofen 400 milligram) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times a day as needed until the stent will be removed in clinic a week later.
Also known as: Non-Opioid
Amount of Pain Medication Used
Number of tablets taken after surgery
Time frame: between baseline through day 7
Number of Subjects Who Need Additional Pain Medication and/or Refill
Number of Subjects Who Need Additional Pain medication and/or Refill
Time frame: baseline through day 7
Urinary Index
Ureteral stent symptom questionnaire Urinary Symptom score ranges from 11 to 56 with a higher score denoting a worse outcome.
Time frame: day 7
| Milestone | Opioid Group | Non-Opioid Group |
|---|---|---|
| Started | 12 | 10 |
| Completed | 7 | 3 |
| Not completed | 5 | 7 |
| Withdrew: Lost to follow-up | 5 | 7 |
Number of tablets taken after surgery
| tablets | Opioid Group | Non-Opioid Group |
|---|---|---|
| Amount of Pain Medication Used | 7.3 (3 to 25) | 6.67 (0 to 11) |
Number of Subjects Who Need Additional Pain medication and/or Refill
| Participants | Opioid Group | Non-Opioid Group |
|---|---|---|
| Number of Subjects Who Need Additional Pain Medication and/or Refill | 0 | 0 |
Ureteral stent symptom questionnaire Urinary Symptom score ranges from 11 to 56 with a higher score denoting a worse outcome.
| score on a scale | Opioid Group | Non-Opioid Group |
|---|---|---|
| Urinary Index | 29.2 (20 to 42) | 22.3 (16 to 27) |
Collected over baseline through month 6. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Opioid Group | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Non-Opioid Group | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
12 patients were lost to follow up and as such were not included in the analysis
| Age, Continuous(years) | Opioid Group | Non-Opioid Group | Total |
|---|---|---|---|
| Mean | 57 (28 to 76) | 53 (39 to 71) | 56 (28 to 76) |
| Sex: Female, Male(Participants) | Opioid Group | Non-Opioid Group | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 5 | 2 | 7 |
| Race and Ethnicity Not Collected(Participants) | Opioid Group | Non-Opioid Group | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Opioid Group | Non-Opioid Group | Total |
|---|---|---|---|
| United States | 7 | 3 | 10 |
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Wake Forest University Health Sciences