Comparison of Pregabalin and Cinnarizine on prophylactic treatment of children with migraine

Comparison of Pregabalin and Cinnarizine on prophylactic treatment of children with migraine

A clinical trial with parallel groups, double-blinded, randomized (permuted block randomization), phase 3 on 74 children with migrane, using www.sealedenvelope.com for randomization.

This study is conducted in Rasool Akram Hospital. Children with migraine are randomly assigned into two groups. In the first group, children take Pregabalin oral capsule. In the second group, children take Cinnarizine tablet. In this study, participants and physicians did not know the type of medication they received.

Inclusion criteria: children aged 6 to 17 years with migraine prophylaxis, Migraine diagnosis based on the criteria of the International Headache Society, which includes cases of migraine without aura (5 attacks), migraine with aura (2 attacks), and each attack lasts 1 to 72 hours, and it is pulsating and severe, and accompanied by symptoms With nausea or vomiting, photophobia, phonophobia, Not taking pregabalin and cinnarizine in the past Exclusion Criteria:Drug Intolerance (symptoms such as diarrhea, nausea and vomiting),anaphylaxis, severe dizziness, excessive sleepiness

In the first intervention group, a Pregabalin oral capsule 50 mg or 75 (manufactured by Actoverco, Iran)mg was prescribed for weight of less than 30 kg and more than 30kg respectively, one time a day for 3 month. The second intervention group, a Pregabalin oral capsule 25 mg or 50 (manufactured by Amin pharmaceutical, Iran)mg was prescribed for weight of less than 30 kg and more than 30kg respectively, one time a day for 3 month.

Frequency of migraine headaches

In this study, the block randomization with block size of 4. we used www.sealedenvelope.com website to generate random sequences. The the random list were provided to a epidemiologist who had no involvement in the selection of the type of drug. Then subjects were randomly assigned to two groups of Pregabalin and Cinnarizine

Patient blinding method: Since pregabalin is a capsule and cinnarizine is a tablet, for the similarity of the shape, we put the cinnarizine tablets into powder and inside the pregabalin capsule cover so that both drugs look the same. Doctor's blinding method: The sealed medicine envelopes were given to a researcher who had no involvement in choosing the type of medicine. After the subjects entered the study and their baseline information was collected by the doctor, he sent them to the researcher to get the medicine, and the researcher gave one of the envelopes to the patients, and after that, it was determined in the sheet kept by the researcher that each What medicine did the patient take.