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document
A randomized , double-blinded , placebo-controlled trial of phenytoin for the prevention of early posttraumatic seizures in children with moderate to severe blunt head injury . STUDY OBJECTIVE We determine the efficacy of prophylactic phenytoin in preventing early posttraumatic seizures in children with moderate to severe blunt head injury . METHODS Children younger than 16 years and experiencing moderate to severe blunt head injury were randomized to receive phenytoin or placebo within 60 minutes of presentation at 3 pediatric trauma centers . The primary endpoint was posttraumatic seizures within 48 hours ; secondary endpoints were survival and neurologic outcome 30 days after injury . A Bayesian decision-theoretic clinical trial design was used to determine the probability of remaining posttraumatic seizure free for each treatment group . RESULTS One hundred two patients were enrolled , with a median age of 6.1 years . Sixty-eight percent were boys . The 2 treatment groups were well matched . During the 48-hour observation period , 3 ( 7 % ) of 46 patients given phenytoin and 3 ( 5 % ) of 56 patients given placebo experienced a posttraumatic seizure . There were no significant differences between the treatment groups in survival or neurologic outcome after 30 days . According to these results , the probability that phenytoin has the originally hypothesized effect of reducing the rate of early posttraumatic seizures by 12.5 % is 0.0053 . The probability that phenytoin has any prophylactic efficacy is 0.383 . The median effect size in this trial was -0.015 ( seizure rate increased by 1.5 % in the phenytoin group ) , 95 % probability interval -0.127 to 0.091 ( 12.7 % higher rate of posttraumatic seizures to a 9.1 % lower rate of posttraumatic seizures with phenytoin ) . CONCLUSION The rate of early posttraumatic seizures in children may be much lower than previously reported . Phenytoin did not substantially reduce that rate .
16607
Intervention_Pharmacological
phenytoin
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Intervention_Pharmacological
phenytoin
16609
Intervention_Pharmacological
phenytoin
16610
Intervention_Control
placebo
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Intervention_Pharmacological
phenytoin
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Intervention_Control
placebo
16613
Intervention_Pharmacological
phenytoin
16614
Intervention_Pharmacological
phenytoin
16615
Intervention_Pharmacological
phenytoin
16616
Intervention_Pharmacological
phenytoin
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Intervention_Pharmacological
Phenytoin
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Outcome_Physical
posttraumatic seizures
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Outcome_Physical
posttraumatic seizure
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Outcome_Mortality
survival
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Outcome_Physical
neurologic outcome
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Outcome_Physical
rate of early posttraumatic seizures
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Outcome_Other
prophylactic efficacy
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Outcome_Physical
posttraumatic seizures
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Participant_Condition
Children younger than 16 years and experiencing moderate to severe blunt head injury
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Participant_Condition
group .
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Participant_Sample-size
46
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Participant_Sample-size
56