ABSTRAK Latar belakang: Migren merupakan penyebab tersering nyeri kepala berulang pada anak dan remaja. Efikasi amitriptilin sebagai terapi preventif nyeri kepala migren telah luas berkembang pada dewasa, sedangkan pemakaiannya pada anak dan remaja masih memiliki keterbatasan data. Tujuan: Menilai efikasi amitriptilin sebagai terapi preventif serangan nyeri kepala migren pada remaja. Metode: Suatu penelitian uji klinis acak tersamar tunggal dilakukan di Medan, Sumatera Utara antara bulan Juli hingga Oktober 2009. Penderita yang memenuhi kriteria migren sesuai dengan The International Headache Society (IHS) dimasukkan dalam penelitian. Partisipan dibagi atas dua grup yaitu grup amitriptilin yang mendapat 10 mg amitriptilin atau grup plasebo selama 3 bulan. Frekuensi nyeri kepala dinilai dalam hari per bulan, durasi dinilai dalam jam dan disabilitas fungsi dinilai dengan menggunakan Pediatric Migraine Disability Assessment Scale (PedMIDAS). Efikasi pengobatan dinilai sebelum, selama dan setelah pengobatan. Hasil: Sebanyak 98 orang remaja mengikuti penelitian dengan rentang usia 12 hingga 19 tahun (rerata 14.69 tahun), dan dibagi atas dua kelompok. Dibandingkan sebelum pengobatan, terdapat perbedaan yang bermakna pada frekuensi nyeri kepala dan skor PedMIDAS pada kelompok amitriptilin (P=0.001, IK 95% (2.023;2.937) dan P=0.001, IK 95% (7.664;9.756), tetapi tidak pada kelompok plasebo. (P>0.05). Terdapat perbedaan yang bermakna pada frekuensi, durasi dan disabilitas fungsi pada kelompok amitriptilin dibandingkan plasebo setelah 3 bulan.( P< 0.05). Kesimpulan: Amitriptilin efektif sebagai terapi preventif serangan nyeri kepala migren pada remaja setelah pengobatan selama 3 bulan. Kata kunci: Amitriptilin, preventif, migren, remaja 16 ABSTRACT Background: Migraine is a cause of recurrent headache in childhood. The efficacy of amitriptyline is well known as a prophylactic treatment in adults, whereas in children and adolescents do not have sufficient data. Objective: To determine the efficacy of amitriptyline as the prophylactic treatment of migraine in adolescents. Methods: We conduct a single-blind randomized controlled trial in Medan, North Sumatra, from July until October 2009. Participants eligible for migraine according to International Headache Society criteria were included in the study. They were divided into two groups, each group was given 10 mg of amitriptyline or placebo for 3 months. Headache frequency was measured in headache days per month, duration was measured in hours and functional disability was measured by Pediatric Migraine Disability Assessment Scale (PedMIDAS). The efficacy was measured before, during and after intervention. Results: A total of 98 patients, ranging in age from 12 until19 years (mean age 14.69 years) were enrolled to the study, and divided into amitriptyline and placebo groups. Compared to baseline, there were significant difference on headache frequency and PedMIDAS score in amitriptyline group (P=0.001, 95%CI (2.023;2.937) and P=0.001, 95%CI (7.664;9.756), but not in placebo group (P>0.05). There were significant differences on frequency, duration, and functional disability in amitriptyline groups compared to placebo after 3 months of treatment (P< 0.05). Conclusion: Amitriptyline appears to be effective in prophylactic treatment of migraine in adolescent after 3 months of intervention. Key words: Amitriptyline, prophylaxis, migraine, adolescents 17