Trial · NCT03584373
Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery.
NCT03584373, Phase 3, Completed, Montefiore Medical Center; results first posted 2023-12-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery. Trials, record NCT03584373. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03584373
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery.
- NCT number
- NCT03584373
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 119 participants, actual
- Lead sponsor
- Montefiore Medical Center
- Conditions
- Nephrolithiasis
- Interventions
- Ketorolac Oral Tablet [Toradol], Acetaminophen, Oxycodone Acetaminophen
- First posted
- 2018-07-12
- Last updated
- 2023-12-18
- Results first posted
- 2023-12-18
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Satisfaction With Pain Relief | 1 week post surgery | The patient will be administered a survey and asked to rate satisfaction with pain relief since the time of surgery and being on the assigned medication. Scoring will be on an 11-point ordinal numeric rating scale, with 0 being not satisfied with pain relief, and 10 being well-satisfied. Higher scores are indicative of greater satisfaction with pain relief |
| Primary | Current Pain Intensity Level | 1 week post surgery | The patient will be administered a survey and asked to rate their current pain intensity level (1 week post surgery) on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scores are indicative of greater pain intensity. |
| Primary | Peak Pain Intensity Level | 1 week post surgery | The patient will be administered a survey and asked to rate the worst/peak pain intensity level since undergoing the surgery. The patient will be asked to rate this worst pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scoring is indicative of worst/peak pain intensity level since the time of surgery |
| Primary | Average Pain Intensity Level | 1 week post surgery | The patient will be administered a survey and asked to rate their average pain intensity level since undergoing surgery. The patient will be asked to rate this average pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scores are indicative of higher average pain intensity. |
| Primary | Perception of an Acceptable Pain Intensity Level | 1 week post surgery | The patient will be administered a survey and asked to rate what their perception or belief of an acceptable pain intensity level would be since undergoing the surgery. The patient will be asked to rate this acceptable pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 equaling no pain, and 10 being the worst possible pain. Higher scores are indicative of the patient's belief of an acceptable pain intensity level. |
| Secondary | Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery | 1 week post surgery | Unused medications is defined as the proportion of prescribed pills that were unused at 1 week post surgery as reported by the patient. More unused medications may indicate the potential to decrease the dosage needed. |
| Secondary | Rates of Constipation | 1 week post surgery | Percentage of patients who experienced constipation any time during the week after surgery. A lower percentage of constipation may indicate less incidence of adverse events. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Satisfaction With Pain Relief | 1 week post surgery | Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm. | score on a scale | MEAN |
| PRIMARY | Current Pain Intensity Level | 1 week post surgery | Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm. | score on a scale | MEAN |
| PRIMARY | Peak Pain Intensity Level | 1 week post surgery | Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm. | score on a scale | MEAN |
| PRIMARY | Average Pain Intensity Level | 1 week post surgery | Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm. | score on a scale | MEAN |
| PRIMARY | Perception of an Acceptable Pain Intensity Level | 1 week post surgery | Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm. | score on a scale | MEAN |
| SECONDARY | Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery | 1 week post surgery | Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm. | proportion of unused pills | MEAN |
| SECONDARY | Rates of Constipation | 1 week post surgery | Data was not collected and analyzed for the 7 participants who were lost to follow up in the non-opioid analgesia arm and 8 participants who were lost to follow up in the opioid analgesia arm. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Satisfaction With Pain Relief | Non-Opioid Analgesia | 8.70 | Standard Deviation 2.01 | score on a scale | |
| Satisfaction With Pain Relief | Opioid Analgesia | 8.85 | Standard Deviation 1.49 | score on a scale | |
| Current Pain Intensity Level | Non-Opioid Analgesia | 1.14 | Standard Deviation 1.94 | score on a scale | |
| Current Pain Intensity Level | Opioid Analgesia | 1.37 | Standard Deviation 2.08 | score on a scale | |
| Peak Pain Intensity Level | Non-Opioid Analgesia | 5.61 | Standard Deviation 3.41 | score on a scale | |
| Peak Pain Intensity Level | Opioid Analgesia | 7.52 | Standard Deviation 3.00 | score on a scale | |
| Average Pain Intensity Level | Non-Opioid Analgesia | 3.34 | Standard Deviation 2.57 | score on a scale | |
| Average Pain Intensity Level | Opioid Analgesia | 4.50 | Standard Deviation 2.69 | score on a scale | |
| Perception of an Acceptable Pain Intensity Level | Non-Opioid Analgesia | 2.73 | Standard Deviation 2.48 | score on a scale | |
| Perception of an Acceptable Pain Intensity Level | Opioid Analgesia | 3.28 | Standard Deviation 2.85 | score on a scale |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Non-Opioid Analgesia | 51 | |
| Overall Study | STARTED | Opioid Analgesia | 54 | |
| Overall Study | COMPLETED | Non-Opioid Analgesia | 44 | |
| Overall Study | COMPLETED | Opioid Analgesia | 46 | |
| Overall Study | NOT COMPLETED | Non-Opioid Analgesia | 7 | |
| Overall Study | NOT COMPLETED | Opioid Analgesia | 8 |
Source ClinicalTrials.gov
Adverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypotension | Vascular disorders | Non-Opioid Analgesia | 0 | 51 | 0 |
| other | Hypotension | Vascular disorders | Opioid Analgesia | 1 | 54 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Non-Opioid Analgesia | 1 | 51 | 1 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Opioid Analgesia | 0 | 54 | 0 |
| other | Anemia | Blood and lymphatic system disorders | Non-Opioid Analgesia | 1 | 51 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Opioid Analgesia | 0 | 54 | 0 |
| serious | Leukocytosis | Blood and lymphatic system disorders | Non-Opioid Analgesia | 0 | 51 | 0 |
| serious | Leukocytosis | Blood and lymphatic system disorders | Opioid Analgesia | 1 | 54 | 1 |
| serious | Fever | General disorders | Non-Opioid Analgesia | 1 | 51 | 1 |
| serious | Fever | General disorders | Opioid Analgesia | 1 | 54 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Non-Opioid Analgesia | 0 | 51 |
| Total, all-cause mortality | Opioid Analgesia | 0 | 54 |
| Total, other adverse events | Non-Opioid Analgesia | 2 | 51 |
| Total, other adverse events | Opioid Analgesia | 1 | 54 |
| Total, serious adverse events | Non-Opioid Analgesia | 5 | 51 |
| Total, serious adverse events | Opioid Analgesia | 7 | 54 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Non-Opioid Analgesia vs Opioid Analgesia: Rates of Constipation | Trial comparisons |
| Non-Opioid Analgesia vs Opioid Analgesia: deaths from any cause | Trial comparisons |
| Non-Opioid Analgesia vs Opioid Analgesia: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03584373
GET https://conductscience.org/api/trials/v1/NCT03584373/events?page=2