Comparison · NCT05820685-sae
Standard of Care + Dronabinol vs Standard of Care: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Standard of Care + Dronabinol vs Standard of Care: serious adverse events. Trial comparisons, record NCT05820685-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05820685-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0556 | 0.0328 | 0.0927 | wilson | |
| Risk in group 2 | 0.0426 | 0.0233 | 0.0765 | wilson | |
| Risk difference, group 1 minus group 2 | 0.013 | -0.0279 | 0.0549 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.31 | 0.584 | 2.92 | log | |
| Odds ratio, group 1 over group 2 | 1.32 | 0.569 | 3.08 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Standard of Care + Dronabinol than on Standard of Care | 76.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard of care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Standard of Care + Dronabinol | Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement.~Dronabinol: Participants will receive Dronabinol 10 mg every 12 hours scheduled. Providers will have the ability to adjust this pain regimen based on clinical judgement. | 13 | 234 | EG001 |
| Group 2 | Standard of Care | Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol): Participants will receive acetaminophen 1000 mg every six hours, naproxen 500 mg every 12 hours, and gabapentin 300 mg every eight hours. Participants will also receive Oxycodone 5 mg or Tramadol 50 mg every six hours as needed for breakthrough pain. Providers will have the ability to adjust this pain regimen based on clinical judgement. | 10 | 235 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From hospital admission up to hospital discharge (about 11 days)
Source ClinicalTrials.gov
Trial
- Title
- Dronabinol On the Pain Experience
- NCT number
- NCT05820685
- Phases
- PHASE4
- Conditions
- Trauma Injury
- Interventions
- Standard of Care (acetaminophen +naproxen +gabapentin + as needed oxycodone or Tramadol), Dronabinol
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Results first posted
- 2025-06-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05820685?tab=results
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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