Phase 4
N=289
The Montefiore Metoclopramide Study
Nausea · Extrapyramidal Symptoms
Bottom Line
View on ClinicalTrials.gov: NCT00475306 ↗Enrolled (actual)
289
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcome: Primary: Nausea Scale — 0; 0; 0; 0 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- metoclopramide 10 mg (Drug); Diphenhydramine 25 mg (Drug); Placebo (Drug); Metoclopramide 20 mg (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Feb 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Nausea Scale |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Akathisia |
9; 12; 5; 8 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- primary or secondary complaints of nausea/vomiting
- age 21-65
Exclusion Criteria
- pregnancy
- use of anti-histamine or dopamine antagonist as outpatient and/or within last 24 hours of presentation
- previous adverse reaction to study medications
- use of opioid medications prior to study start time within that ED visit
Data sourced from ClinicalTrials.gov (NCT00475306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.