Comparison · NCT01267136-sae
Capital® With Codeine Suspension vs Tramadol Suspension: 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. Capital® With Codeine Suspension vs Tramadol Suspension: serious adverse events. Trial comparisons, record NCT01267136-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01267136-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 | 0.0238 | 0.00422 | 0.123 | wilson | |
| Risk in group 2 | 0.0238 | 0.00422 | 0.123 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.101 | 0.101 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1 | 0.0647 | 15.5 | log | |
| Odds ratio, group 1 over group 2 | 1 | 0.0605 | 16.5 | log | |
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Capital® With Codeine Suspension | Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg \[=0.3 mL/kg\] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day) | 1 | 42 | EG000 |
| Group 2 | Tramadol Suspension | Tramadol suspension : Liquid tramadol 1.05 mg/kg \[=0.3 mL/kg\] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day). | 1 | 42 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy
- NCT number
- NCT01267136
- Phases
- PHASE4
- Conditions
- Tonsillitis, Pain
- Interventions
- Codeine with acetaminophen, Tramadol suspension
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Results first posted
- 2014-04-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01267136?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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