Journal of child neurology
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Randomized Controlled Trial Clinical Trial
High-dose riboflavin for migraine prophylaxis in children: a double-blind, randomized, placebo-controlled trial.
This is the first study to evaluate the efficacy of riboflavin for migraine prophylaxis in children. This was a randomized, double-blind study of riboflavin (200 mg daily) versus placebo in 48 children. The primary efficacy measure was the number of patients achieving a 50% or greater reduction in the number of migraine attacks per 4 weeks. ⋯ There were no differences between riboflavin and placebo for primary or secondary outcome variables. These results suggest that riboflavin is not an effective therapy for preventing migraine in children. A high placebo responder rate was seen, with implications for other studies of migraine in children.
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Randomized Controlled Trial Comparative Study
Intravenous sodium valproate versus diazepam infusion for the control of refractory status epilepticus in children: a randomized controlled trial.
An open-label, randomized controlled study was conducted at a tertiary care teaching hospital to compare efficacy and safety of intravenous sodium valproate versus diazepam infusion for control of refractory status epilepticus. Forty children with refractory status epilepticus were randomized to receive either intravenous sodium valproate or diazepam infusion. Refractory status epilepticus was controlled in 80% of the valproate and 85% of the diazepam patients. ⋯ None of the patients in the valproate group required ventilation or developed hypotension, whereas in the diazepam group 60% required ventilation and 50% developed hypotension after starting diazepam infusion. No adverse effects on liver functions were seen with valproate. It is concluded that intravenous sodium valproate is an effective alternative to diazepam infusion in controlling refractory status epilepticus in children and is free of respiratory depression and hypotension.
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Randomized Controlled Trial
Topiramate in the prophylaxis of pediatric migraine: a double-blind placebo-controlled trial.
Several large, randomized controlled trials have demonstrated the efficacy of topiramate in migraine prophylaxis in adults. However, there are limited data about the use of topiramate in migraine prophylaxis in children. We conducted this single-center, double-blind, placebo-controlled trial to evaluate the efficacy and safety of topiramate in the prophylaxis of migraine in children. ⋯ The decrease in school absenteeism was significant with topiramate compared with placebo (P = .002). Weight loss, decreased concentration in school, sedation, and parasthesias were important side effects with topiramate. Most of these side effects were mild to moderate and were not significant enough to cause dropout from the study.
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Randomized Controlled Trial
Randomized trial of parent management training in children with tic disorders and disruptive behavior.
Oppositional, defiant, and disruptive behaviors are common in clinical samples of children with tic disorders. In this study, we sought to evaluate the short-term efficacy of a structured parent training program in children with tic disorders accompanied by disruptive behavior. Children with tic disorders and at least a moderate level of disruptive behavior were randomly assigned to a 10-session structured parent management training program or to continue treatment as usual. ⋯ On the Improvement scale of the Clinical Global Impression, a rater masked to treatment assignment classified 7 of 11 subjects who completed parent management training as much improved or very much improved compared with 2 of 12 subjects in the treatment as usual group (Fisher exact test, P < .05). These results suggest that parent management training is helpful for short-term improvement in disruptive behavior problems in children with tic disorders. Larger randomized clinical trials are needed.
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Randomized Controlled Trial Comparative Study Clinical Trial
Continuous midazolam versus diazepam infusion for refractory convulsive status epilepticus.
The objective of this study was to compare the efficacy of continuous midazolam and diazepam infusion for the control of refractory status epilepticus. An open-label, randomized control study was undertaken at the Pediatric Emergency and Intensive Care Service of a multidisciplinary teaching and referral hospital. Subjects included 40 children, 2 to 12 years of age, with refractory status epilepticus (motor seizures uncontrolled after two doses of diazepam, 0.3 mg/kg per dose, and phenytoin infusion, 20 mg/kg). ⋯ About half of the patients needed mechanical ventilation and 40% had hypotension in both groups, but the mortality was higher in the midazolam group (38%) as compared to the diazepam group (10.5%, P < .1 > .05). Continuous midazolam and diazepam infusions were equally effective for control of refractory status epilepticus. However, midazolam was associated with more seizure recurrence and higher mortality in refractory status epilepticus predominantly caused by central nervous system infections.