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| Sponsor: | Montefiore Medical Center |
|---|---|
| Information provided by: | Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT00475306 |
Purpose
Metoclopramide is a dopamine antagonist frequently used for the treatment of nausea, vomiting, and migraine headaches in Emergency Departments (EDs). However, little research has focused on the optimal dose of metoclopramide for treatment of nausea in the ED. We propose a randomized, double-blind, placebo controlled trial to investigate the optimal dose of metoclopramide for treatment of nausea.
| Condition | Intervention | Phase |
|---|---|---|
|
Nausea Extrapyramidal Symptoms |
Drug: metoclopramide Drug: Diphenhydramine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Facorial Design Study to Optimize the Dose of Parenteral Metoclopramide |
| Estimated Enrollment: | 280 |
| Study Start Date: | May 2007 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Metoclopramide 20+diphenhydramine |
Drug: metoclopramide
anti-emetic
Drug: Diphenhydramine
prophylaxis against akathisia
|
| Active Comparator: Metoclopramide 20+placebo |
Drug: metoclopramide
anti-emetic
|
| Active Comparator: Metoclopramide 10 + placebo |
Drug: metoclopramide
anti-emetic
|
| Active Comparator: Metoclopramide 10+diphenhydramine |
Drug: metoclopramide
anti-emetic
Drug: Diphenhydramine
prophylaxis against akathisia
|
The most effective dose of metoclopramide for treatment of nausea in the ED setting has not been thoroughly investigated. One pilot study among ED patients in Australia found no statistical difference between 10 mg and 0.4 mg/kg; another investigation suggests that the anti-emetic effect of 10 mg 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 ED study will compare the anti-emetic efficacy of 10 mg and 20 mg 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 MIA. This investigation will assess the use of 25 mg of diphenhydramine in preventing MIA in ED patients being treated for nausea/vomiting.
Eligibility| Ages Eligible for Study: | 21 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| Montefiore Medical Center | |
| Bronx, New York, United States, 10461 | |
| Principal Investigator: | Benjamin W Friedman, MD | Montefiore Medical Center |
| Study Director: | Brooke Bender, MD | Albert Einstein College of Medicine of Yeshiva University |
More Information
| Responsible Party: | Benjamin friedman, Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT00475306 History of Changes |
| Other Study ID Numbers: | 07-01-005 |
| Study First Received: | May 16, 2007 |
| Last Updated: | October 26, 2009 |
| Health Authority: | United States: Institutional Review Board |
|
Metoclopramide Nausea Akathisia Emergency department |
|
Nausea Basal Ganglia Diseases Signs and Symptoms, Digestive Signs and Symptoms Brain Diseases Central Nervous System Diseases Nervous System Diseases Diphenhydramine Metoclopramide Promethazine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hypnotics and Sedatives Central Nervous System Depressants Anti-Allergic Agents Anesthetics, Local Anesthetics Sensory System Agents Antipruritics |