[Update on Current Care Guideline: Headache (children)]. / Päänärky (lapset).

The majority of children with recurrent headaches can be effectively treated in the primary health care. Paracetamol and ibuprofen are the recommended first-line pain medications. Limited evidence is available on the effectiveness of triptans in children and adolescents. However, nasal sumatriptan and possibly oral rizatriptan and nasal zolmitriptan can be considered for children and adolescents, as well as oral almotriptan for adolescents. Propranolol is the first-line prophylactic medication for migraine.

Long-term open-label safety study of rizatriptan acute treatment in pediatric migraineurs.

OBJECTIVE: To evaluate the safety/tolerability of rizatriptan in the long-term acute treatment of migraine in pediatric patients. BACKGROUND: Acute migraine treatment options for children are limited. A recent single-attack trial demonstrated that rizatriptan is effective in eliminating migraine headache pain in this population. We evaluated the long-term safety and efficacy of rizatriptan when used for intermittent acute treatment. METHODS: Open-label study in pediatric migraineurs ages 12-17 years. Patients weighing <40 kg received rizatriptan (orally disintegrating tablet) 5 mg, and those weighing ≥40 kg received 10 mg. Patients could treat up to 8 mild/moderate/severe migraine attacks per month for up to 12 months. One dose of study medication was allowed in a 24-hour period. RESULTS: A total of 674 patients were enrolled, and 606 patients were treated with study medication (N = 583 for 10 mg, N = 23 for 5 mg). The mean duration in the study was 292 days, and the mean number of doses of study medication taken was 20. Over the course of the study within 14 days post-any-dose, 66.0% (400) of the 606 treated patients had any adverse event, 2.3% (14) discontinued due to an adverse event, 2.6% (16) had a serious adverse event, and 23.4% (142) had a triptan-related adverse event. Of the 16 patients with serious adverse events within 14 days post-any-dose, the adverse events in 3 were considered drug-related; all 3 patient's adverse events were classified as serious only because they were associated with an overdose (use of >1 dose of study medication in a 24-hour period). The mean percentage of patient's attacks with pain freedom at 2-hours post-dose was 46.3%; this was relatively consistent over time (Months 1-3 = 43.7%, Months 4-6 = 51.9%, Months 7-9 = 49.9%, Months 10-12 = 49.5%). CONCLUSION: Rizatriptan was generally safe and well tolerated in the long-term acute treatment of migraine in pediatric patients aged 12-17 years and demonstrated a consistent treatment effect over time.

Efficacy and tolerability of rizatriptan in pediatric migraineurs: results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design.

BACKGROUND: Treatment options for children and adolescents with migraine are limited. This study evaluated rizatriptan for the acute treatment of migraine in children and adolescents. METHODS: Randomized, double-blind, placebo-controlled, parallel-group trial in migraineurs 6-17 years old with unsatisfactory response to nonsteroidal anti-inflammatory drugs or acetaminophen/paracetamol. The trial included a double-blind run-in with weight-based rizatriptan dosing (5 mg for < 40 kg, 10 mg for ≥ 40 kg). In the Stage 1 run-in, patients were randomized in a ratio of 20:1 placebo:rizatriptan and were instructed to treat within 30 minutes of a moderate/severe migraine. Patients with mild/no pain after 15 minutes of treatment (responders) took no further study medication, whereas patients with moderate/severe pain (non-responders) proceeded to take study medication in Stage 2. Non-responders who received placebo in Stage 1 were randomized 1:1 to rizatriptan:placebo, whereas non-responders who received rizatriptan in Stage 1 were allocated to placebo in Stage 2. The primary efficacy endpoint was pain freedom at 2 hours after Stage 2 dose in 12-17-year-olds. RESULTS: A higher proportion of 12-17-year-olds on rizatriptan had pain freedom at 2 hours compared with those on placebo: 87/284 (30.6%) versus 63/286 (22.0%), odds ratio = 1.55 [95% CI: 1.06 to 2.26], p = 0.025. Adverse events within 14 days of dose in 12-17-year-olds were similar for rizatriptan and placebo. The pattern of findings was similar in 6-17-year-olds. CONCLUSION: Rizatriptan demonstrated a statistically significant improvement over placebo in eliminating pain and was generally well tolerated in migraineurs aged 12-17 and 6-17 years. TRIAL REGISTRATION: ClinicalTrials.gov NCT01001234.

Migraine in children and adolescents: a guide to drug treatment.

Migraine is a common disorder in children and adolescents, with a prevalence of 5 and 10%, respectively. Some patients may have recognisable factors that trigger or aggravate migraine attacks, such as flickering or bright lights, strong smells and noise, and where possible these should be avoided. It is also wise to maintain a lifestyle where children receive regular meals and get sufficient sleep. If used, acute pharmacological treatment should be given at the onset of an attack, followed by a rest or sleep. According to recent literature, paracetamol (acetaminophen) and ibuprofen can be recommended for the acute treatment of migraine attacks in children and adolescents, and sumatriptan nasal spray can be recommended for adolescents. The oral formulation of sumatriptan has not shown efficacy in paediatric patients, and the subcutaneous injection, although somewhat effective, is not an ideal formulation for this patient group. There are too few data on the efficacy of the other 'triptans' to recommend their use in children and adolescents. There are less data on the use of prophylactic drugs in paediatric patients. In systematic studies, only flunarizine, which is not available in many countries, and propranolol have been found to be effective. A pilot placebo-controlled study suggests that topiramate might also be effective. Several other agents are commonly used to prevent migraine attacks in children (e.g. amitriptyline, valproic acid [sodium valproate]) despite a lack of robust research into their efficacy.

Nasal sumatriptan is effective in treatment of migraine attacks in children: A randomized trial.

OBJECTIVE: To investigate the efficacy of nasal sumatriptan in migraine attacks of children and adolescents. METHODS: A double-blind, placebo-controlled, two-way crossover trial was conducted in three hospital outpatient departments, with 8 to 17 year olds diagnosed with migraine serving as subjects (International Headache Society 1988). A single dose of sumatriptan nasal spray and a matching placebo were administered at home during two attacks. The sumatriptan dose was 10 mg for a body weight of 20 to 39 kg and 20 mg for those with a body weight of >/==" BORDER="0">40 kg. The primary efficacy endpoint was headache relief by two grades on a 5-grade face scale at 2 hours. RESULTS: Eighty-three patients used both treatments and 11 only the first. At 2 hours, the primary endpoint was reached nearly twice as often after sumatriptan (n = 53/83; 64%) as after placebo (n = 32/83; 39%) (p = 0.003). Already at 1 hour, headache relief was seen more often after sumatriptan (n = 42/83; 51%) than after placebo (n = 24/83; 29%) (p = 0.014). The difference was even more obvious in patients who received the 20-mg dose as well as in the intention-to-treat analyses (n = 94). Other endpoints, including child's preference and using rescue medication, also favored sumatriptan. The most common adverse effect was a bad taste after sumatriptan, reported in 29% (n = 26/90) of the attacks. No serious adverse effects were observed. CONCLUSION: Nasal sumatriptan is an effective and well-tolerated treatment for migraine attacks in children over 8 years of age.