ABSTRACT
OBJECTIVE: To compare efficacy and safety of topiramate (TPM) and propranolol for migraine prophylaxis in children. METHODS: In a parallel single-blinded randomized clinical trial, 5-15 y-old referred migraineurs to Pediatric Neurology Clinic of Shahid Sadoughi Medical Sciences University, Yazd, Iran from May through October 2011, were evaluated. Patients were distributed into two groups, 50 of whom were treated with 3 mg/kg/d of topiramate (TPM) and another group of 50, were treated with 1 mg/kg of propranolol for 3 mo. Primary endpoints were efficacy in reduction of monthly frequency, severity, duration and headache related disability. Secondary outcome was clinical side effects. RESULTS: Fifty two girls and 48 boys with mean age of 10.34 ± 2.31 y were evaluated. Monthly frequency, severity and duration of headache decreased with TPM, from 13.88 ± 8.4 to 4.13 ± 2.26 attacks, from 6.32 ± 1.93 to 2.8 ± 2.12, and from 2.36 ± 1.72 to 0.56 ± 0.5 h, respectively. Monthly frequency, severity and duration of headache also decreased with propranolol from 16.2 ± 6.74 to 8.8 ± 4.55 attacks, from 6.1 ± 1.54 to 4.8 ± 1.6 and from 2.26 ± 1.26 to 1.35 ± 1.08 h, respectively. Pediatric Migraine Disability Assessment score reduced from 31.88 ± 9.72 to 9.26 ± 7.21 with TPM and from 33.08 ± 8.98 to 23.64 ± 9.88 with propranolol. Transient mild side effects were seen in 18 % of TPM and in 10 % of propranolol (P = 0.249) groups. CONCLUSIONS: Topiramate is more effective than propranolol for pediatric migraine prophylaxis.
Subject(s)
Anticonvulsants/therapeutic use , Fructose/analogs & derivatives , Migraine Disorders/prevention & control , Propranolol/therapeutic use , Adolescent , Child , Child, Preschool , Female , Fructose/therapeutic use , Humans , Male , Single-Blind Method , TopiramateABSTRACT
We conducted this single blind randomized clinical trial to compare the efficacy and safety of oral chloral hydrate and intranasal midazolam for induction of sedation for computerized tomography scan of brain in children. Participants aged 1-10 years (n=60) were randomized to receive 100 mg/kg chloral hydrate orally with intra nasal normal saline OR intranasal midazolam 0.2 mg/kg with oral normal saline. Adequate sedation (Ramsay sedation score of four) was obtained and CT scan completed successfully in 76.7% of chloral hydrate group and in 40% of midazolam group (P=0.004). No significant difference was seen for side effects frequency between the two drugs (10% in chloral hydrate, 3.3% in midazolam group; P=0.34). We conclude that oral chloral hydrate can be considered as a safe and effective drug for sedation in children undergoing CT scan of brain.
