Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475306
Status:
COMPLETED
Last Update Posted:
2012-12-31
First Post:
2007-05-16
Brief Title:
The Montefiore Metoclopramide Study
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
A Randomized Facorial Design Study to Optimize the Dose of Parenteral Metoclopramide
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 04 milligramskilogram 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 nauseavomiting
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 nauseavomiting
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None