Clinical Trial: Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Intravenous Metoclopramide in the Acute Treatment of Migraine: A Double-blind, Randomized, Placebo-controlled Trial

Brief Summary: Migraine attacks were frequently diagnosed in the emergency departments. Also intravenous metoclopramide was a commonly used drug in the acute abortive treatment of migraine. However, the role of metoclopramide was based on three randomized, placebo-controlled studies, which were carried out with relatively few patients. Those trials suggested that metoclopramide produced larger improvements in visual analog scale (VAS) scores, however they revealed conflicting results and had significant methodological problems (risk of bias, allocation of concealment, intention-to-treat analysis). The investigators aimed to analyse the effects of intravenous metoclopramide in acute migraine attacks comparing with placebo.

Detailed Summary:
Sponsor: Kocaeli University

Current Primary Outcome: The difference between pain scores for both drugs [ Time Frame: 15th and 30th minutes ]

The difference between pain scores (10- point numeric rating scale score) for metoclopramide and placebo groups


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Nausea and vomiting [ Time Frame: 30th minute ]
    Change in nausea/vomiting status of the participants
  • Adverse reactions [ Time Frame: 30th minute ]
    Number of participants with adverse events
  • Need for rescue analgesic [ Time Frame: 30th minute ]
    Number of patients needed rescue analgesic at 30th minute
  • Change in the headache intensity [ Time Frame: Between 24th and 72th hours ]
    Change in the headache intensity
  • Duplicative presentation to the emergency department [ Time Frame: Between 24th and 72th hours ]
    With telephone call


Original Secondary Outcome: Same as current

Information By: Kocaeli University

Dates:
Date Received: December 5, 2014
Date Started: December 2014
Date Completion:
Last Updated: January 3, 2017
Last Verified: January 2017