|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Factorial Assignment, Safety/Efficacy Study |
| 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 |
|---|---|
| Metoclopramide 20+diphenhydramine: Active Comparator |
Drug: metoclopramide
anti-emetic
Drug: Diphenhydramine
prophylaxis against akathisia
|
| Metoclopramide 20+placebo: Active Comparator |
Drug: metoclopramide
anti-emetic
|
| Metoclopramide 10 + placebo: Active Comparator |
Drug: metoclopramide
anti-emetic
|
| Metoclopramide 10+diphenhydramine: Active Comparator |
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: | Montefiore Medical Center ( Benjamin friedman ) |
| Study ID Numbers: | 07-01-005 |
| Study First Received: | May 16, 2007 |
| Last Updated: | October 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00475306 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Metoclopramide Nausea Akathisia Emergency department |
|
Neurotransmitter Agents Signs and Symptoms, Digestive Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antiemetics Anesthetics Metoclopramide Signs and Symptoms Promethazine Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Antipruritics Nausea Dermatologic Agents |
Gastrointestinal Agents Histamine Agents Central Nervous System Depressants Dopamine Antagonists Anti-Allergic Agents Pharmacologic Actions Anesthetics, Local Histamine Antagonists Autonomic Agents Histamine H1 Antagonists Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents Diphenhydramine |