Comparison · NCT01785459-deaths
Treatment vs Standard Care: deaths from any cause
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. Treatment vs Standard Care: deaths from any cause. Trial comparisons, record NCT01785459-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01785459-deaths
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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 | 0.0000000000000000278 | 0.242 | wilson | |
| Risk in group 2 | 0 | 0 | 0.259 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.259 | 0.242 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: standard care.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Treatment | 0.5% bupivacaine~0.5% bupivacaine: The injection site will be prepared using common sterile technique with 2% chlorhexidine. 1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Location would be approximately 1 cm superior to spinous process of C7 and approximately 2-3 cm laterally. The needle is inserted 1 to 1.5 inches into the paraspinous musculature at this level. A 27-gauge needle would be used to minimize tissue trauma and pain to the patient. Our method of injection is followed quite closely with the technique depicted in multiple retrospective studies. We chose to follow previous reported technique secondary to good clinical efficacy and impressive documented safety profile. Additionally, before injection, aspiration would be performed to lesson chance of intravascular injection. | 0 | 12 | EG001 |
| Group 2 | Standard Care | intravenous Prochlorperazine~Standard Care: 10 mg Intravenous injection of Prochlorperazine | 0 | 11 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
- 72 hours and immediately following injection
Source ClinicalTrials.gov
Trial
- Title
- Bupivacaine for Benign Headache in the ED
- NCT number
- NCT01785459
- Phases
- PHASE2
- Conditions
- Benign Headache
- Interventions
- 0.5% bupivacaine, Standard Care
- Lead sponsor
- Wake Forest University Health Sciences
- Results first posted
- 2019-04-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01785459?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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