Migraine Disorders
Conditions
Keywords
migraine disorders, migraine with aura, migraine without aura, pain management, emergency department
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.
Interventions
Intravenous form of metoclopramide is in the same appearance with placebo
DRUGPlacebo
Intravenous form of metoclopramide is in the same appearance with placebo
DRUGFentanyl
Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute
Sponsors
Kocaeli University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presenting to the emergency department with migraine attack (with aura or without aura, according to International Headache Society criteria, 2013) * The patients older than 18 years * Patients who agree to participate to the study by reading and signing the informed consent document
Exclusion criteria
* The patients younger than 18 years * Pregnants * Patients taking any analgesic drugs last 2 hours * Documented or declared allergy to metoclopramide * Patients who are hemodynamically unstable * Patients who do not agree to participate to the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The difference between pain scores for both drugs | 15th and 30th minutes | The difference between pain scores (10- point numeric rating scale score) for metoclopramide and placebo groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nausea and vomiting | 30th minute | Change in nausea/vomiting status of the participants |
| Adverse reactions | 30th minute | Number of participants with adverse events |
| Need for rescue analgesic | 30th minute | Number of patients needed rescue analgesic at 30th minute |
| Change in the headache intensity | Between 24th and 72th hours | Change in the headache intensity |
| Duplicative presentation to the emergency department | Between 24th and 72th hours | With telephone call |
Countries
Turkey (Türkiye)
Outcome results
None listed