Frisium (Clobazam) for Febrile Seizures in Children
Primary Recommendation
Clobazam (Frisium) should NOT be used for routine prophylaxis of simple febrile seizures, as the American Academy of Pediatrics explicitly recommends against both continuous and intermittent anticonvulsant therapy due to potential toxicities outweighing minimal risks. 1, 2
When Clobazam May Be Considered (Highly Selected Cases Only)
For complex febrile seizures (prolonged >15 minutes, focal features, or multiple within 24 hours) with severe parental anxiety or multiple recurrences, intermittent clobazam during febrile illness may be considered as an alternative to diazepam, though this does not improve long-term outcomes. 1, 3
Evidence Supporting Selective Use:
Clobazam demonstrated superior efficacy to diazepam in one trial, reducing recurrence from 21.2% to 9.4% (relative risk 2.6 times lower), with fewer adverse effects including less drowsiness, sedation, and ataxia. 4
In a Brazilian study, intermittent clobazam reduced recurrence to 1.7% (3/171 febrile episodes) compared to 22.9% (11/48 episodes) with antipyretics alone (p<0.0001). 5
One trial showed dramatic reduction with clobazam at 6 months (RR 0.09,95% CI 0.02-0.30), though this was against an unusually high 83.3% control recurrence rate requiring replication. 6
Dosing Protocol (If Used):
Weight-based dosing during febrile episodes: ≤5 kg = 5 mg/day; 5-10 kg = 10 mg/day; 11-15 kg = 15 mg/day; >15 kg = 20 mg/day. 5
Administer orally at fever onset (temperature >37.8°C/100.4°F) and continue throughout febrile illness. 5
Critical Limitations and Harms
Adverse effects occur in 35.7% of children, primarily vomiting, somnolence, and hyperactivity, though these may not occur with every administration. 5
The number needed to treat to prevent one recurrence with intermittent benzodiazepines is approximately 14, indicating limited clinical benefit. 3
No evidence exists that prophylactic treatment prevents the development of epilepsy (baseline risk ~1%, same as general population) or improves long-term neurocognitive outcomes. 1, 2
Simple febrile seizures cause no structural brain damage, IQ decline, academic impairment, or behavioral abnormalities. 2
Who Should NOT Receive Clobazam
Children with simple febrile seizures (brief <15 minutes, generalized, single episode in 24 hours) should never receive prophylactic anticonvulsants. 1, 2
The harm-benefit analysis clearly favors no treatment for simple febrile seizures. 1, 2
Alternative Management Strategy
The preferred approach is "rescue" rectal diazepam given by parents at seizure onset to prevent prolonged seizures (febrile status epilepticus), rather than prophylactic therapy. 7, 3
This strategy targets the rare but concerning complication of prolonged febrile seizures without exposing children to continuous medication side effects. 7
Candidates for rescue benzodiazepines include children with prior prolonged febrile seizure or poor access to medical care. 3
Essential Parent Education
Recurrence risk is ~30% overall, ~50% if first seizure occurs before 12 months of age, and ~30% if first seizure after 12 months. 2
Even children with multiple simple febrile seizures, first seizure before 12 months, and family history of epilepsy have only 2.4% risk of developing epilepsy by age 25 years. 2
Antipyretics (acetaminophen, ibuprofen) do not prevent febrile seizures or reduce recurrence, though they improve comfort. 1, 2