The Montefiore Metoclopramide Study

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.

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.

Intervention(s) in this Clinical Trial

• Drug: metoclopramide
  • anti-emetic
• Drug: Diphenhydramine
  • prophylaxis against akathisia

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Metoclopramide 20+diphenhydramine
• Active Comparator: Metoclopramide 20+placebo
• Active Comparator: Metoclopramide 10 + placebo
• Active Comparator: Metoclopramide 10+diphenhydramine

Primary Measures

• Nausea scale
  • Time Frame: 60m
    Safety Issue?: No

Secondary Measures

• Akathisia scale
  • Time Frame: 60m
    Safety Issue?: Yes

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 opioid 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

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Montefiore Medical Center Other

Overall Clinical Trial Officials and Contacts

Benjamin W Friedman, MD Principal Investigator Montefiore Medical Center  

Information obtained from ClinicalTrials.gov on February 12, 2012

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

Study ID Number: 07-01-005

ClinicalTrials.gov Identifier: NCT00475306

Health Authority: United States: Institutional Review Board