Clinical trial NCT00475306: The Montefiore Metoclopramide Study
Official title: A Randomized, Facorial Design Study to Optimize the Dose of Parenteral Metoclopramide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nausea
Extrapyramidal Symptoms
Keywords: Metoclopramide
Nausea
Akathisia
Emergency department
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2007-05-21
Enrollment: 289
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed description: The most effective dose of metoclopramide for treatment of nausea in the emergency department setting has not been thoroughly investigated. One pilot study among emergency department patients in Australia found no statistical difference between 10 mg and 0.4 milligrams/kilogram; another investigation suggests that the anti-emetic effect of 10 milligrams 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 emergency department study will compare the anti-emetic efficacy of 10 milligrams and 20 milligrams of 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 metoclopramide induced akathisia. This investigation will assess the use of 25 mg of diphenhydramine in preventing metoclopramide induced akathisia in ED patients being treated for nausea/vomiting.

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

Primary outcomes:
measure: Nausea Scale
timeFrame: 60 minutes
Secondary outcomes:
measure: Number of Participants With Akathisia
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Benjamin W Friedman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Albert Einstein College of Medicine
name: Brooke Bender, MD
role: STUDY_DIRECTOR
References: