Comparison · NCT04296396-a5aaf4d3
Individualized Opioid Prescription Protocol (IOPP) vs Fixed Opioid Prescription: Pain Interference Score ≥ 4 at 2 Weeks Post Discharge
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 Protocol (IOPP) vs Fixed Opioid Prescription: Pain Interference Score ≥ 4 at 2 Weeks Post Discharge. Trial comparisons, record NCT04296396-a5aaf4d3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04296396-a5aaf4d3
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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 | 0.165 | 0.151 | 0.18 | wilson | |
| Risk in group 2 | 0.172 | 0.157 | 0.187 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00669 | -0.0274 | 0.0141 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.961 | 0.85 | 1.09 | log | |
| Odds ratio, group 1 over group 2 | 0.953 | 0.822 | 1.11 | log | |
| Number needed to treat, for one fewer participant with the outcome on Individualized Opioid Prescription Protocol (IOPP) than on Fixed Opioid Prescription | 150 | 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 Protocol (IOPP) | Individualized opioid prescription protocol (IOPP) with 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. | 415 | 2,514 | OG000 |
| Group 2 | Fixed Opioid Prescription | Fixed amount of opioids (20 tablets of oxycodone 5mg) | 427 | 2,486 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Pain Interference Score ≥ 4 at 2 Weeks Post Discharge
- Description
Pain interference scores ≥ 4 on the Brief Pain Inventory (numeric scale from 0 to 10) at 2 weeks post-discharge. 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. This outcome asks participants to indicate their pain scores for the week prior to completing the inventory.
- Time frame
- 2 weeks post discharge
- Population
- Data were missing for 234 participants in the IOPP group and for 286 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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