Comparison · NCT03396588-sae
Clonidine vs Morphine: 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. Clonidine vs Morphine: serious adverse events. Trial comparisons, record NCT03396588-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03396588-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 | 0.15 | 0.081 | 0.261 | wilson | |
| Risk in group 2 | 0.25 | 0.158 | 0.372 | wilson | |
| Risk difference, group 1 minus group 2 | -0.1 | -0.24 | 0.0444 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.6 | 0.285 | 1.26 | log | |
| Odds ratio, group 1 over group 2 | 0.529 | 0.211 | 1.33 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Clonidine than on Morphine | 10 | 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 | Clonidine | Babies randomized to clonidine will receive 1mcg/kg/dose (with a dosing interval of 3 or 4 hours).~Clonidine: 1mcg/kg/dose (with a dosing interval of 3 or 4 hours), increases by 25% of initial dose every 12-24 hrs. Decrease by 10% of max dose every 24 hrs. | 9 | 60 | EG000 |
| Group 2 | Morphine | Babies randomized to morphine will receive 0.06 mg/kg/dose (with a dosing interval of 3 or 4 hours).~Morphine: Starting dose is 0.06 mg/kg/dose (every 3 or 4 hours), increases by 25% of initial dose every 12-24 hrs. Decrease by 10% of max dose every 24 hrs. | 15 | 60 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were collected from the time of consent until the subject was off study. For subjects who completed the entire study, the maximum amount of time for AE collection is 26 months from date of consent.
Source ClinicalTrials.gov
Trial
- Title
- Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain
- NCT number
- NCT03396588
- Phases
- PHASE3
- Conditions
- Neonatal Abstinence Syndrome
- Interventions
- Clonidine, Morphine
- Lead sponsor
- Henrietta Bada
- Results first posted
- 2025-05-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03396588?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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