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Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea, vomiting, and migraine headaches in Emergency Departments. However, little research has focused on the optimal dose of metoclopramide for treatment of nausea in the emergency department. We propose a randomized, double-blind, placebo controlled trial to investigate the optimal dose of metoclopramide for treatment of nausea.
The most effective dose of metoclopramide for treatment of nausea in the emergency department setting has not been thoroughly investigated. One pilot study among emergency department patients in Australia found no statistical difference between 10 mg and 0.4 milligrams/kilogram; another investigation suggests that the anti-emetic effect of 10 milligrams of metoclopramide is no more effective than placebo. In contrast, investigations focusing on chemotherapy patients and post-operative patients suggest that higher dosage metoclopramide is more effective in treating nausea and vomiting. This emergency department study will compare the anti-emetic efficacy of 10 milligrams and 20 milligrams of metoclopramide by using the visual analog scale.
In addition to evaluation of dose, we will evaluate one of the most common side affects of metoclopramide, akathisia. Akathisia is characterized by a subjective component of restlessness and an objective component in the form of the inability to remain motionless. Anti-cholinergic medications are known to reduce extrapyramidal symptoms such as akathisia when dopamine function is impaired in the basal ganglia. In fact, the use of diphenhydramine has been shown to reduce the incidence of akathisia in patients receiving a different anti-emetic, prochlorperazine. However, no research has focused on the use of anti-cholinergic medications to reduce metoclopramide induced akathisia. This investigation will assess the use of 25 mg of diphenhydramine in preventing metoclopramide induced akathisia in ED patients being treated for nausea/vomiting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metoclopramide 20+diphenhydramine | Active Comparator | Metoclopramide 20 mg + diphenhydramine, delivered intravenously over 15 minutes |
|
| Metoclopramide 20+placebo | Active Comparator | Metoclopramide 20 mg + placebo, delivered intravenously over 15 minutes |
|
| Metoclopramide 10 + placebo | Active Comparator | Metoclopramide 10mg + placebo, delivered intravenously over 15 minutes |
|
| Metoclopramide 10+diphenhydramine | Active Comparator | Metoclopramide 10 mg + diphenhydramine 25 mg, delivered intravenously over 15 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metoclopramide 10 mg | Drug | an anti-emetic medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Nausea Scale | Patients were asked to report their level of nausea on a scale for 0 to 10, with 0 representing no nausea and 10 the worst nausea imaginable | 60 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Akathisia | The akathisia outcome was reported as follows: Either development of akathisia as measured using the Short Akathisia Instrument (Vinson DR. Journal of Emergency Medicine. 2006; 31:139-145)or use of rescue medication for treatment of akathisia.The short akathisia instrument briefly measures subjective and objective restlessness. | 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin W Friedman, MD | Montefiore Medical Center | Principal Investigator |
| Brooke Bender, MD | Albert Einstein College of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10461 | United States |
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Patients who presented to one ED with nausea were eligible for participation
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| ID | Title | Description |
|---|---|---|
| FG000 | Metoclopramide 20 mg+Diphenhydramine | Metoclopramide 20mg co-administered with diphenhydramine 25 mg, intravenously |
| FG001 | Metoclopramide 20+Placebo | Metoclopramide 20 mg co-administered with placebo, intravenously |
| FG002 | Metoclopramide 10 + Placebo | Metoclopramide 10 mg co-administered with placebo, intravenously |
| FG003 | Metoclopramide 10+Diphenhydramine | Metoclopramide 10 mg co-administered with diphenhydramine 25 mg, intravenously |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metoclopramide 20mg+Diphenhydramine | Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously |
| BG001 | Metoclopramide 20+Placebo | Metoclopramide 20 mg co-administered with placebo, intravenously |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nausea Scale | Patients were asked to report their level of nausea on a scale for 0 to 10, with 0 representing no nausea and 10 the worst nausea imaginable | Only patients who received the investigational medication are included in this analysis. Please see the participant flow section for more details. | Posted | Median | Inter-Quartile Range | units on a scale | 60 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metoclopramide 20mg+Diphenhydramine | Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. BW Friedman | Montefiore Medical Center | 718-920-6626 | befriedm@montefiore.org |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| D011595 | Psychomotor Agitation |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020820 | Dyskinesias |
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| ID | Term |
|---|---|
| D008787 | Metoclopramide |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
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| Diphenhydramine 25 mg | Drug | used for prophylaxis against akathisia |
|
| Placebo | Drug | placebo |
|
| Metoclopramide 20 mg | Drug | Metoclopramide 20 mg |
|
| BG002 | Metoclopramide 10 + Placebo | Metoclopramide 10 mg co-administered with placebo, intravenously |
| BG003 | Metoclopramide 10+Diphenhydramine | Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Please note: Only patients who completed the study are reported here | Count of Participants | Participants |
|
| OG002 | Metoclopramide 10 + Placebo | Metoclopramide 10 mg co-administered with placebo, intravenously |
| OG003 | Metoclopramide 10+Diphenhydramine | Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously |
|
|
| Secondary | Number of Participants With Akathisia | The akathisia outcome was reported as follows: Either development of akathisia as measured using the Short Akathisia Instrument (Vinson DR. Journal of Emergency Medicine. 2006; 31:139-145)or use of rescue medication for treatment of akathisia.The short akathisia instrument briefly measures subjective and objective restlessness. | Only patients who received the investigational medication are included in this analysis. Please see participant flow for details | Posted | Number | participants | 60 minutes |
|
|
|
| 0 |
| 72 |
| 0 |
| 72 |
| EG001 | Metoclopramide 20+Placebo | Metoclopramide 20 mg co-administered with placebo, intravenously | 0 | 71 | 0 | 71 |
| EG002 | Metoclopramide 10 + Placebo | Metoclopramide 10 mg co-administered with placebo, intravenously | 0 | 72 | 0 | 72 |
| EG003 | Metoclopramide 10+Diphenhydramine | Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously | 0 | 71 | 0 | 71 |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011596 | Psychomotor Disorders |
| D019954 | Neurobehavioral Manifestations |
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D062365 |
| Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| D005021 | Ethylamines |
| D000588 | Amines |
| D001559 | Benzhydryl Compounds |