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Comparison · NCT03818919-sae

Post-Operative Non Opioid Pain Protocol vs Post-Operative Traditional Pain Protocol: 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. Post-Operative Non Opioid Pain Protocol vs Post-Operative Traditional Pain Protocol: serious adverse events. Trial comparisons, record NCT03818919-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03818919-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 1000.184wilson
Risk in group 2000.143wilson
Risk difference, group 1 minus group 20-0.1430.184newcombe hybrid score
Risk ratio, group 1 over group 2loga group has no participants with the outcome
Odds ratio, group 1 over group 2loga cell of the two-by-two table is zero
Number needed to harmfrom the risk difference intervalthe two groups' risks are equal

Groups2

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

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Post-Operative Non Opioid Pain Protocol
Patients in this group will be administered a novel multimodal pain protocol post-operatively consisting of: Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam~Celecoxib: Post-Operative Non Opioid Pain Protocol~Ketorolac: Post-Operative Non Opioid Pain Protocol~Gabapentin: Post-Operative Non Opioid Pain Protocol~Acetaminophen: Post-Operative Non Opioid Pain Protocol~Diazepam: Post-Operative Non Opioid Pain Protocol
017EG000
Group 2Post-Operative Traditional Pain ProtocolPatients will be administered a traditional post-operative pain protocol consisting of: Hydrocodone-Acetaminophen Cap 5-500~Hydrocodone-Acetaminophen: Traditionally used narcotic pain protocol023EG001

Harm

What it counts
Total, serious adverse events
Time frame
10 days postop

Source ClinicalTrials.gov

Trial

Title
Nonopioid Analgesia After Rotator Cuff Repair
NCT number
NCT03818919
Phases
PHASE2
Conditions
Rotator Cuff Tear
Interventions
Celecoxib, Ketorolac, Gabapentin, Acetaminophen, Diazepam, Hydrocodone-Acetaminophen
Lead sponsor
Henry Ford Health System
Results first posted
2024-04-02

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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