Comparison · NCT00875550-sae
Dexmedetomidine Low Dose vs Dexmedetomidine High Dose: 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 Low Dose vs Dexmedetomidine High Dose: serious adverse events. Trial comparisons, record NCT00875550-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00875550-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 | 0.0112 | 0.00199 | 0.0609 | wilson | |
| Risk in group 2 | 0.0116 | 0.00206 | 0.063 | wilson | |
| Risk difference, group 1 minus group 2 | -0.000392 | -0.0526 | 0.0502 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.966 | 0.0614 | 15.2 | log | |
| Odds ratio, group 1 over group 2 | 0.966 | 0.0595 | 15.7 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Dexmedetomidine Low Dose than on Dexmedetomidine High Dose | 2,550 | 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 Low Dose | Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores. | 1 | 89 | EG000 |
| Group 2 | Dexmedetomidine High Dose | Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores. | 1 | 86 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects
- NCT number
- NCT00875550
- Phases
- PHASE3
- Conditions
- Sedation
- Interventions
- Dexmedetomidine, Midazolam, Fentanyl, Morphine
- Lead sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
- Results first posted
- 2014-10-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00875550?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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