Comparison · NCT01825941-ba474ab0
Metoclopramide + Diphenhydramine vs Metoclopramide + Placebo: Number of Participants With Sustained Headache Relief Assessed by Self-evaluation
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Metoclopramide + Diphenhydramine vs Metoclopramide + Placebo: Number of Participants With Sustained Headache Relief Assessed by Self-evaluation. Trial comparisons, record NCT01825941-ba474ab0. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01825941-ba474ab0
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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 | 0.4 | 0.309 | 0.498 | wilson | |
| Risk in group 2 | 0.369 | 0.282 | 0.465 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0311 | -0.101 | 0.162 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.08 | 0.765 | 1.54 | log | |
| Odds ratio, group 1 over group 2 | 1.14 | 0.648 | 2.01 | log | |
| Number needed to treat, for one more participant with the outcome on Metoclopramide + Diphenhydramine than on Metoclopramide + Placebo | 32.2 | 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 | Metoclopramide + Diphenhydramine | Metoclopramide 10 milligrams + Diphenhydramine 50 milligrams, administered as an intravenous drip over 15 minutes~metoclopramide: 10 milligrams, administered intravenously over 15 minutes~diphenhydramine: 50 milligrams, administered intravenously over 15 minutes | 40 | 100 | OG000 |
| Group 2 | Metoclopramide + Placebo | Metoclopramide 10mg + placebo, administered intravenously over 15 minutes~metoclopramide: 10 milligrams, administered intravenously over 15 minutes~placebo | 38 | 103 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Sustained Headache Relief Assessed by Self-evaluation
- Description
Sustained headache relief is defined as achieving a headache level of mild or none within two hours and maintaining a level of mild or none for 48 hours. Patient self-evaluated pain level is solicited every half hour for two hours in the Emergency Department and then by telephone 48 hours after discharge from emergency department
- Time frame
- up to 2 hours in Emergency Department, 48 hours after discharge from Emergency Department
- Population
Source ClinicalTrials.gov
Trial
- Title
- Diphenhydramine for Acute Migraine
- NCT number
- NCT01825941
- Phases
- PHASE4
- Conditions
- Migraine
- Interventions
- metoclopramide, diphenhydramine, placebo
- Lead sponsor
- Montefiore Medical Center
- Results first posted
- 2018-06-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01825941?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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