Comparison · NCT04296396-3330715f
Individualized Opioid Prescription vs Fixed Opioid Prescription: Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory
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. Individualized Opioid Prescription vs Fixed Opioid Prescription: Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory. Trial comparisons, record NCT04296396-3330715f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04296396-3330715f
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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 | 0.595 | 0.575 | 0.614 | wilson | |
| Risk in group 2 | 0.601 | 0.582 | 0.62 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00673 | -0.0337 | 0.0202 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.989 | 0.945 | 1.03 | log | |
| Odds ratio, group 1 over group 2 | 0.972 | 0.869 | 1.09 | log | |
| Number needed to treat, for one fewer participant with the outcome on Individualized Opioid Prescription than on Fixed Opioid Prescription | 149 | from the risk difference interval | the interval includes no difference |
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 | Individualized Opioid Prescription | Individualized opioid prescription protocol and shared decision making~0 to 20 tablets of oxycodone 5mg: Individualized opioid prescription protocol (IOPP) that includes shared decision making. IOPP will be based on inpatient oral opioid intake during the 24 hour period prior to randomization and should not include the 12 hours immediately after the cesarean. | 1,497 | 2,518 | OG000 |
| Group 2 | Fixed Opioid Prescription | fixed opioid prescription of 20 tablets of oxycodone 5mg | 1,535 | 2,553 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Worst Pain Score of Moderate to Severe on the Brief Pain Inventory
- Description
Number of participants with moderate to severe pain at 1 week post-discharge; moderate to severe pain is defined as a value of 4 or higher on the Worst Pain question of the Brief Pain Inventory (BPI) in the last 24 hours. The BPI measures pain severity on a numeric scale of 0 to 10, with 0 being no pain and 10 being the highest level of pain.
- Time frame
- 1 week post hospital discharge
- Population
Of 2273 participants in the fixed group, 1 was enrolled in the study for a second pregnancy. Only the first pregnancy was included in the analysis. The primary analysis included participants who completed the highest pain in the last 24 hours on the Brief Pain Inventory at 1 week post-discharge. This data was missing for 230 participants in the individualized opioid prescription group and 219 participants in the fixed group.
Source ClinicalTrials.gov
Trial
- Title
- Opioid Prescription After Cesarean Trial
- NCT number
- NCT04296396
- Phases
- PHASE3
- Conditions
- Pregnancy Related, Opioid Use, Pain
- Interventions
- 0 to 20 tablets of oxycodone 5mg, Fixed opioid prescription
- Lead sponsor
- The George Washington University Biostatistics Center
- Results first posted
- 2023-10-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04296396?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.govNone 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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