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| Sponsored by: |
Vanderbilt University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00655642 |
Purpose
The purpose of this study is to compare the effectiveness of ondansetron, metoclopramide, and promethazine for the treatment of nausea in the adult emergency department population.
We hypothesize that a single intravenous dose of ondansetron is more effective in reducing nausea than a single IV dose of metoclopramide, promethazine or normal saline placebo in undifferentiated adult emergency department patients.
| Condition | Intervention |
|---|---|
|
Nausea |
Drug: ondansetron, metoclopramide, and promethazine |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Single Group Assignment |
| Official Title: | A Randomized, Double Blind, and Placebo-Controlled Trial Comparing Ondansetron, Metoclopramide and Promethazine for the Treatment of Nausea and Vomiting in the Adult Emergency Department. |
| Estimated Enrollment: | 600 |
| Study Start Date: | March 2007 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
Patients will be randomized to intravenously receive ondansetron 4mg, metoclopramide 10 mg, promethazine 12.5 mg or a volume matched saline placebo.
As an ED standard of care for vomiting, all patients will receive approximately 500 mL of normal saline hydration during the initial 30 minutes of the study. Nausea will be evaluated on a 100-mm visual analog scale (VAS) at time 0 and 30 minutes after treatment.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37240 | |
| Principal Investigator: | Tyler W Barrett, MD | Vanderbilt University |
More Information
| Responsible Party: | Vanderbilt University Medical Center ( Tyler W Barrett ) |
| Study ID Numbers: | VUMC 0612369 |
| Study First Received: | April 4, 2008 |
| Last Updated: | January 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00655642 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Neurotransmitter Agents Vomiting Signs and Symptoms, Digestive Psychotropic Drugs Antiemetics Anesthetics Metoclopramide Signs and Symptoms Promethazine Dopamine Hypnotics and Sedatives Antipruritics Nausea Ondansetron Tranquilizing Agents |
Central Nervous System Depressants Anti-Allergic Agents Antipsychotic Agents Anesthetics, Local Serotonin Histamine Histamine Antagonists Histamine phosphate Histamine H1 Antagonists Emergencies Anti-Anxiety Agents Dopamine Agents Peripheral Nervous System Agents Diphenhydramine |
|
Neurotransmitter Agents Signs and Symptoms, Digestive Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Anesthetics Antiemetics Metoclopramide Signs and Symptoms Serotonin Antagonists Promethazine Sensory System Agents Therapeutic Uses Hypnotics and Sedatives Antipruritics |
Nausea Ondansetron Dermatologic Agents Tranquilizing Agents Gastrointestinal Agents Histamine Agents Central Nervous System Depressants Dopamine Antagonists Anti-Allergic Agents Antipsychotic Agents Anesthetics, Local Pharmacologic Actions Serotonin Agents Histamine Antagonists Autonomic Agents |
