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

Young, Kelly D.; Okada, Pamela J.; Sokolove, Peter E.; Palchak, Michael J.; Panacek, Edward A.; Baren, Jill M.; Huff, Kenneth R.; McBride, Duncan Q.; Inkelis, Stanley H.; Lewis, Roger J.

doi:10.1016/j.annemergmed.2003.09.016

Cited by 86 publications

(44 citation statements)

References 41 publications

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“…The success of AED prophylaxis has not been consistently demonstrated, with previous studies showing both positive (Lewis et al, 1993) and negative effects (Young et al, 2004). In this study we could not determine if therapeutic drug levels were achieved.…”

Section: Discussionmentioning

confidence: 79%

“…Although AED prophylaxis is commonly used in clinical practice, studies investigating its efficacy fail to show consistent benefit, defined as EPTS prevention (Lewis et al, 1993;Young et al, 2004). Consensus management guidelines for severe TBI in adults also recommend consideration of prophylactic antiepileptic therapy to prevent EPTS, yet both call for more research on AED selection, optimal timing, and effect on outcome (Bratton et al, 2007;Chang and Lowenstein, 2003).…”

Section: Introductionmentioning

confidence: 97%

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Early Post-Traumatic Seizures in Moderate to Severe Pediatric Traumatic Brain Injury: Rates, Risk Factors, and Clinical Features

Liesemer

Bratton

Zebrack

et al. 2011

Journal of Neurotrauma

136

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We performed a retrospective, observational study at a level I pediatric trauma center of children with moderate-to-severe traumatic brain injury (TBI) from January 2002 to September 2006 to identify clinical and radiographic risk factors for early post-traumatic seizures (EPTS). Two hundred and ninety-nine children ages 0-15 years were evaluated, with 24 excluded because they died before the initial head computed tomography (CT) was obtained (n=20), or because their medical records were missing (n=4). Records were reviewed for accident characteristics, pre-hospital hypoxia or hypotension, initial non-contrast head CT characteristics, seizure occurrence, antiepileptic drug (AED) administration, and outcome. All care was at the discretion of the treating physicians, including the use of AEDs and continuous electroencephalogram (EEG) monitoring in patients receiving neuromuscular blocking agents. The primary outcome was seizure activity during the first 7 days as determined by clinician observation or EEG analysis. Of the 275 patients included in the study, 34 had identified EPTS (12%). Risk factors identified on bivariable analysis included pre-hospital hypoxia, young age, non-accidental trauma (NAT), severe TBI, impact seizure, and subdural hemorrhage, while receiving an AED was protective. Independent risk factors identified by multivariable analysis were age <2 years (OR 3.0 [95% CI 1.0,8.6]), Glasgow Coma Scale (GCS) score ≤8 (OR 8.7 [95% CI 1.1,67.6]), and NAT as a mechanism of injury (OR 3.4 [95% CI 1.0,11.3]). AED treatment was protective against EPTS (OR 0.2 [95% CI 0.07,0.5]). Twenty-three (68%) patients developed EPTS within the first 12 h post-injury. This early peak in EPTS activity and demonstrated protective effect of AED administration in this cohort suggests that to evaluate the maximal potential benefit among patients at increased risk for EPTS, future research should be randomized and prospective, and should intervene during pre-trauma center care with initiation of continuous EEG monitoring as soon as possible.

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Section: Discussionmentioning

confidence: 79%

Section: Introductionmentioning

confidence: 97%

Early Post-Traumatic Seizures in Moderate to Severe Pediatric Traumatic Brain Injury: Rates, Risk Factors, and Clinical Features

Liesemer

Bratton

Zebrack

et al. 2011

Journal of Neurotrauma

136

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“…Since the incidence of EPTS is increased with younger age [104][105][106], acute prophylaxis may be particularly beneficial. Pediatric-only studies using phenytoin prophylaxis, however, have shown mixed results [107][108][109], and new studies also suggest the possibility of agespecific toxicity (see Effects of Medications section below). Future studies specifically in children are needed to examine the effects of prophylaxis with alternative anticonvulsants, and should include seizure outcomes as well as cognitive and developmental outcomes.…”

Section: Posttraumatic Seizure Prophylaxismentioning

confidence: 95%

Pediatric traumatic brain injury: not just little adults

Giza

Mink²,

Madikians³

2007

Current Opinion in Critical Care

143

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“…This raises potential concerns that are more fully discussed below. Finally, followup, at least across the period of time reported in these 21 studies, is often 100% and fell below 88% in only one study [20] , although data regarding this point are also unavailable in 6 published reports. Taken together, data presented in table 1 suggest that standards for reporting the results of experimental studies in children with severe TBI need to be made more uniform in order to develop a more adequate understanding of potential biases.…”

mentioning

confidence: 99%

Clinical Trials in Pediatric Traumatic Brain Injury: Unique Challenges and Potential Responses

Natale¹,

Joseph

Pretzlaff³

et al. 2006

Dev Neurosci

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In order to optimize pediatric traumatic brain injury translational and clinical research, scientific and ethical challenges need to be recognized and addressed. Having recently conducted a multisite phase II safety/feasibility trial of magnesium sulfate as a neuroprotective agent, we supplement our own experience by a mini review of similar studies, identifying challenges and possible responses from the perspective of families, investigators, funding agencies and society.

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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

Cited by 86 publications

References 41 publications

Early Post-Traumatic Seizures in Moderate to Severe Pediatric Traumatic Brain Injury: Rates, Risk Factors, and Clinical Features

Early Post-Traumatic Seizures in Moderate to Severe Pediatric Traumatic Brain Injury: Rates, Risk Factors, and Clinical Features

Pediatric traumatic brain injury: not just little adults

Clinical Trials in Pediatric Traumatic Brain Injury: Unique Challenges and Potential Responses

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