Comparison · NCT03933397-sae
Patient-Specific Protocol vs Weight-based Protocol: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
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ConductScience Library. Patient-Specific Protocol vs Weight-based Protocol: serious adverse events. Trial comparisons, record NCT03933397-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03933397-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 | 0.00000000000000000694 | 0.0713 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0771 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0771 | 0.0713 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Patient-Specific Protocol | Patients assigned to this treatment protocol will be given pain medicine(s) based on pain medicine(s) taken at home \& what was needed during past emergency department visits to treat pain. Medicines include opioids, morphine or hydromorphone. A member of the outpatient provider team reviews patient's medical record to determine patient's maximum home opioid dose, previous ED analgesic medication(s) \& doses that have been effective \& safe in the past. Patient's regular hematologist/sickle cell team will write the treatment plans.~Medications will be given every 20-30 minutes for up to 6 hours. Morphine: 4 mg for participants weighing \<50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing \> or equal to 90 kgs. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%.~Hydromorphone: 1 mg for participants weighing \<60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing \> or equal to 90 kgs. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%.~There are only two, not four, randomized interventions in this trial: patient specific pain management protocol and weight-based pain management protocol. Here the word protocol refers to pain management approach. The AEs have been submitted by each of these two interventions. | 0 | 50 | EG000 |
| Group 2 | Weight-based Protocol | Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight.~Weight-based Protocol: Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Medicines will include opioids, either morphine or hydromorphone. Plans will be written by the patients regular hematologist/sickle cell team.~Morphine: 4 mg for participants weighing \<50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%.~Hydromorphone: 1 mg for participants weighing \<60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%.~There are only two, not four, randomized interventions in this trial: patient specific pain management protocol and weight-based pain management protocol. Here the word protocol refers to pain management approach. The AEs have been submitted by each of these two interventions. | 0 | 46 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From enrollment in the emergency department through 7 days post enrollment for up to 8 days.
Source ClinicalTrials.gov
Trial
- Title
- Comparing Individualized vs. Weight Based Protocols to Treat Vaso-Occlusive Episodes in Sickle Cell Disease
- NCT number
- NCT03933397
- Phases
- PHASE3
- Conditions
- Sickle Cell Disease
- Interventions
- Patient-Specific Protocol, Weight-based Protocol, Morphine, Hydromorphone
- Lead sponsor
- Duke University
- Results first posted
- 2023-07-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03933397?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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