Associação de tratamento e metoclopramida no tratamento de crises agudas de enxaqueca: ensaio clínico randomizado controlado e duplo cego.

Abstract

Migraine is a form of common, highly disabling primary headache associated with a high socioeconomic burden and high prevalence. The approach and therapy of this condition ranges from the removal of triggers, use of preventive medications and other therapies. The objective of this study was to evaluate the efficacy of the use of tramadol 50 mg + metoclopramide 5 mg, compared to placebo, for the treatment of acute attacks of migraine. Methods: A randomized, controlled, double-blind clinical trial was conducted in patients attending the Neurology outpatient clinic of the Alcides Carneiro University Hospital located in Campina Grande, Brazil, evaluating the clinical and socioeconomic profile and comparing the efficacy of the combination of tramadol 50mg and metoclopramide 5mg, through Visual Analogue Scale, frequency and duration of migraine and need for rescue medication. The data were collect before the intervention and 30 days after the intervention, by telephone. Results: A total of 66 people participated in the metoclopramide study compared to placebo (84.4% vs 88.2%), with a diagnosis of migraine without aura (56.3% vs. 64.7%). After the 30 days, only 43 participants gave a return of the medication, between the groups it was evaluated reduction reduction of EVA> 50% before and after the episode of migraine as primary outcome and there was no significant difference between the group using tramadol with metoclopramide and placebo (p = 0.11). The main side effect was nausea and / or vomiting (40.9% vs 15%, p = 0.06), without distinction between groups. Conclusions: The use of the combination of metoclopramide and tramadol (50mg / 5mg) was not superior to placebo as a treatment for acute attacks of migraine.