Comparison · NCT04772222-sae
Dexmedetomidine (DMT) 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. Dexmedetomidine (DMT) vs Morphine: serious adverse events. Trial comparisons, record NCT04772222-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04772222-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 | 0.04 | 0.0071 | 0.195 | wilson | |
| Risk in group 2 | 0.0435 | 0.00772 | 0.21 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00348 | -0.173 | 0.156 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.92 | 0.061 | 13.9 | log | |
| Odds ratio, group 1 over group 2 | 0.917 | 0.054 | 15.6 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Dexmedetomidine (DMT) than on Morphine | 288 | 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 | Dexmedetomidine (DMT) | Subjects randomized to DMT arm in a 1:1 ratio. A loading dose of 1 mcg/kg will be given followed by 0.1 to 0.5 mcg/kg/h continuous infusion. The Neonatal Pain, Agitation, and Sedation Scale (N-PASS) will be used to determine infusion rate. | 1 | 25 | EG000 |
| Group 2 | Morphine | Subjects randomized to morphine in a 1:1 ratio. Intermittent dosing every 3-4 hours of 0.02-0.05 mg/kg/dose or continuous infusion of 0.005 to 0.01 mg/kg/hr. The N-PASS will be used to determine dosing and frequency. | 1 | 23 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were reported that occured from randomization to 96 hours of life (study interventions phase). Serious adverse events were recorded if they occurred from randomization to 7 days post last study drug dose or hospital discharge up to 11 days, whichever occurred first.
Source ClinicalTrials.gov
Trial
- Title
- Dexmedetomidine Use in Infants Undergoing Cooling Due to Neonatal Encephalopathy (DICE Trial)
- NCT number
- NCT04772222
- Phases
- PHASE2
- Conditions
- Hypoxic-Ischemic Encephalopathy, Pain
- Interventions
- Dexmedetomidine Hydrochloride, Morphine Sulfate
- Lead sponsor
- University of Utah
- Results first posted
- 2026-03-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04772222?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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