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Comparison · NCT03584373-sae

Non-Opioid Analgesia vs Opioid Analgesia: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Non-Opioid Analgesia vs Opioid Analgesia: serious adverse events. Trial comparisons, record NCT03584373-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03584373-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.0980.04260.21wilson
Risk in group 20.130.06420.244wilson
Risk difference, group 1 minus group 2-0.0316-0.1590.0979newcombe hybrid score
Risk ratio, group 1 over group 20.7560.2562.23log
Odds ratio, group 1 over group 20.730.2162.47log
Number needed to treat, for one fewer participant with a serious adverse event on Non-Opioid Analgesia than on Opioid Analgesia31.7from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Non-Opioid Analgesia
Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed).~Acetaminophen - Oral; patient directed as needed. Not prescribed.~Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet.~Ketorolac Oral Tablet \[Toradol\]: Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.~Acetaminophen: Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.
551EG000
Group 2Opioid Analgesia
Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed).~Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.~Oxycodone Acetaminophen: Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
754EG001

Harm

What it counts
Total, serious adverse events
Time frame
Up to 1 week postoperatively

Source ClinicalTrials.gov

Trial

Title
Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery.
NCT number
NCT03584373
Phases
PHASE3
Conditions
Nephrolithiasis
Interventions
Ketorolac Oral Tablet [Toradol], Acetaminophen, Oxycodone Acetaminophen
Lead sponsor
Montefiore Medical Center
Results first posted
2023-12-18

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
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

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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