Table 14.10 Pharmacological Prevention or Prophylaxis of Post Traumatic Seizures in Children Post ABI
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Author Year Country Study Design Sample Size |
Methods | Outcome |
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Young et al. (2004) RCT USA PEDro=6 NInitial=102, NFinal=69 |
Population: TBI; Phenytoin Group (n=46): Median Age=6.4yr; Gender: Male=31, Female=15; Mean Time Post Injury=34 min; Median GCS=7. Control Group (n=56): Median Age=5. 9yr; Gender: Male=38, Female=18; Mean Time Post Injury=33 min; Median GCS=7. Intervention: Patients were randomized to receive either phenytoin or a placebo. Those in the phenytoin group received a loading dose of 18 mg/kg followed by 2 mg/kg every 8 hr for 48 hr. Phenytoin was prepared in a diluent of water, ethanol, and propylene glycol. Patients assigned to the placebo group received an equivalent volume of the diluent alone, at the same time points. All patients were kept under observation throughout the study. Median time to follow-up was 34.5 d. Outcome Measure: Occurrence of seizure, Neurologic Outcome Score in Infants and Children (NOSIC). |
1. Three patients from each group experienced a posttraumatic seizure. 2. The probability of a posttraumatic seizure was similar between groups with a median effect size of -0.015 (1.5%) higher seizure rate in the phenytoin group. 3. No significant difference was found between groups on the NOSIC (p=0.900). |
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Young et al. (1983) USA RCT PEDro=6 N=41 |
Population: TBI; Phenytoin (n=25): Mean Age=9.3yr; Gender: Male=18, Female=7; Time Post Injury=<24 hr; Severity: Mild/Moderate=15, Severe=10. Controls (n=16): Mean Age=9.2yr; Gender: Male=15, Female=1; Time Post Injury=<24 hr; Severity: Mild/Moderate=6, Severe=10. Intervention: Patients were randomized to receive either phenytoin or a placebo. Phenytoin was administered intravenously at a dosage of 13 mg/kg with the aim of maintaining plasma phenytoin concentration of 10-20 ug/ml. Patients were switched to oral medication as soon as oral doses could be ingested. Any patients who became sensitive to phenytoin were switched to phenobarbital. Blood samples were taken every 24 hr. Follow-up was conducted 18mo post-treatment. Outcome Measure: Phenytoin Plasma Concentration , Occurrence of Seizure. | 1. Three patients receiving phenytoin, one patient receiving placebo and none of the patients that switched from phenytoin to phenobarbital experienced seizures. No significant difference was found between groups. 2. No patients with a phenytoin plasma concentration level above 10 ug/ml experienced a seizure. Of the three who experienced seizures, one patient was found to be at a level of 0-5 ug/ml and two were at a level of 5-10 ug/ml. |
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Chung & O’Brien (2016) USA Post-Test N=34 |
Population: TBI; Median Age=6.0yr; Gender: Male=20, Female=14; Median GCS=8. Intervention: Patients admitted to the pediatric intensive care unit were provided with 5-40 mg/kg day of levetiracetam as prophylaxis against post-traumatic seizures (PTS). Patients were monitored for up to 7 d post injury. Outcome Measure: Incidence of PTS. |
1. Six of the 34 patients (17.6%) developed PTS despite prophylactic levetiracetam. 2. Patients who developed PTS were significantly younger than those who did not (median age of 4 versus 10 respectively; p<0.0001). 3. Patients who developed PTS were significantly more likely to have experienced abusive head trauma (p=0.0004). 4. There was no significant difference in the dosage of levetiracetam between patients who did and did not develop PTS (p=0.870). |
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Vaewpanich & Rice (2016) Thailand Case Series N=16 |
Population: TBI; Mean Age=3.1yr; Gender: Male=8, Female=8; Severity: Mild=5, Severe=11. Intervention: Data was collected from medical records of patients admitted to a Level 1 trauma center between December 2012 and June 2015. Outcomes measured at discharge and at 4-6wk follow-up. Outcome Measure: Incidence of PTS, Glasgow Outcome Scale Extended Pediatric (GOS-E Peds), Speech Pathology Neurocognitive/Functional Evaluations (SPNFE). |
1. Fifteen of 16 patients received prophylactic levetiracetam with additional anti-seizure medications including phenobarbital (n=3), phenytoin (n=4), pentobarbital (n=3) and benzodiazepine (n=3). 2. Despite the administration of prophylactic levetiracetam, four patients (25%) experienced a PTS. All four had experienced non-accidental head trauma. 3. GOS-E Peds and SPNFE at discharge indicated severe disability for all four patients who experienced PTS. |