Previous Randomized Controlled Studies of Prevention of Febrile Seizure Recurrences, Including Antipyretic Treatment
| Camfield, 1980 | Schnaiderman, 1993 | Uhari, 1995 | |
|---|---|---|---|
| Treatment groups (number of children) | Single daily dose of phenobarbital per os 5 mg/kg plus antipyretic instruction of the parents (n = 39) versus antipyretic instruction including oral antipyretics only (n = 40) | Prophylaxis of acetaminophen orally 15–20 mg/kg per 4-hourly dose (n = 53) versus sporadic usage of acetaminophen of a similar oral dose contingent at fever >37.9°C (n = 51) | Diazepam 0.2 mg/kg 8-hourly during fever >38.5°C (n = 81), of which the first dose to be given rectally and additional doses per os, versus placebo (n = 80); additional: cross-over per fever episode with acetaminophen 10 mg/kg 6-hourly during fever >40.0°C (route of administration not reported) versus placebo |
| Temperature measurements | Oral and rectal measurements by the parents at home | Rectal measurements by nurses or parents during hospitalization | Measurements by the parents at home (oral or rectal) |
| Outcome measure | First febrile seizure recurrence in the same or following fever episodes | First febrile seizure recurrence in the same fever episode (multiple type) | Number of febrile seizure recurrences in any of the following fever episodes |
| Body temperature | Body temperature | ||
| Maximum study duration | 12 mo | One fever episode | 2 y |
| Patient inclusion | Simple initial febrile seizure | Simple initial febrile seizure | Simple or complex initial febrile seizure |
| Major difficulties in the evaluation of the results | No standardization of the antipyretic treatment4-a | No placebo control group of antipyretic treatment | No standardization of the antipyretic treatment4-b |
| No placebo control group of antipyretic treatment | Noncomparable outcome measure | ||
| Results | 2 of the 39 patients using phenobarbital plus antipyretic instruction and 10 of the 40 patients with only instruction had a recurrent febrile seizure4-c | 4 of the 53 children using ongoing prophylaxis vs 5 of the 51 children in the sporadic-use group had a recurrent seizure in the same fever episode | 9 of the 173 fever episodes were associated with a recurrence in the acetaminophen group vs 14 of the 170 fever episodes in the placebo group4-d |
| Efficacy of antipyretic preventive treatment as concluded | Not effective | Not effective | Not effective |
↵F4-a All parents received instructions about fever control; no standardized dose per kilogram of bodyweight was administered.
↵F4-b All parents were allowed to administer extra antipyretics whenever they believed they should.
↵F4-c Survival analysis was performed to compare seizure recurrence in the phenobarbital-plus-instruction group and the instruction-only group (P < .02, log-rank).
↵F4-d Survival analysis was performed to compare seizure recurrence in the diazepam group and the placebo group (P = .41, log-rank).