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This study was a prospective, randomized, double-blind, parallel group clinical trial designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the treatment of peripheral vertigo in Emergency Department setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Promethazine | Active Comparator | IV promethazine (25 mg) |
|
| lorazepam | Active Comparator | IV lorazepam (2 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Promethazine | Drug |
| ||
| Lorazepam |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in vertigo intensity. | The primary efficacy outcome was the mean change in the vertigo intensity score between pre- and post-intervention at 2 hours after administration of study medications. | At 2 hours after intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy and Safety outcome measures (nausea change-second dose-adverse events). | Secondary outcomes included, mean change in nausea VAS score, need for second dose of study medications, and the rate of drug-related adverse events for the subjects in each study group after intervention. | At 2-8 hours after intervention. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Emam Hossein Hospital | Tehran | Nezam Abad | 17666-33815 | Iran |
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| ID | Term |
|---|---|
| D014717 | Vertigo |
| ID | Term |
|---|---|
| D015837 | Vestibular Diseases |
| D007759 | Labyrinth Diseases |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D011398 | Promethazine |
| D008140 | Lorazepam |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010640 | Phenothiazines |
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|
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013457 |
| Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |