Official Title: “A Randomized, Facorial Design Study to Optimize the Dose of Parenteral Metoclopramide”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Active Control, Factorial Assignment, Safety/Efficacy Study

The most effective dose of metoclopramide for treatment of nausea in the ED setting has not been thouroughly 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 mediations 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.

Intervention(s) in this Clinical Trial

• Drug: metoclopramide
• Drug: Diphenhydramine

Primary Measures

• Nausea scale
  • Time Frame: 60m
    

Secondary Measures

• Akathisia scale
  • Time Frame: 60m
    

Inclusion Criteria:

• primary or secondary complaints of nausea/vomiting

Exclusion Criteria:

• age 21-65
• 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 opoid medications prior to study start time within that ED visit

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 65 Years

Lead Sponsor: Montefiore Medical Center

Overall Clinical Trial Officials and Contacts

Benjamin W Friedman, MD Principal Investigator Montefiore Medical Center  

Overall Contact: Benjamin Friedman, MD, MS 718-920-6626 befriedma@montefiore.org

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00475306

Study ID Number: MMCMeto

ClinicalTrials.gov Identifier: NCT00475306

Health Authority: United States: Institutional Review Board