The Montefiore Metoclopramide Study

Nausea Clinical Trial

Official title:

A Randomized, Facorial Design Study to Optimize the Dose of Parenteral Metoclopramide

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475306
• Other study ID #: 07-01-005
• Status: Completed
• Phase: Phase 4
• First received: May 16, 2007
• Last updated: November 28, 2012
• Start date: May 2007
• Est. completion date: February 2008

Study information

• Verified date: November 2012
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 289
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Extrapyramidal Symptoms
• Nausea

Intervention

Drug:
• metoclopramide 10 mg
an anti-emetic medication
• Diphenhydramine 25 mg
used for prophylaxis against akathisia
• Placebo
placebo
• Metoclopramide 20 mg
Metoclopramide 20 mg

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nausea Scale	Patients were asked to report their level of nausea on a scale for 0 to 10, with 0 representing no nausea and 10 the worst nausea imaginable	60 minutes	No
Secondary	Number of Participants With Akathisia	The akathisia outcome was reported as follows: Either development of akathisia as measured using the Short Akathisia Instrument (Vinson DR. Journal of Emergency Medicine. 2006; 31:139-145)or use of rescue medication for treatment of akathisia.The short akathisia instrument briefly measures subjective and objective restlessness.	60 minutes	No