Antipyretics for Preventing Recurrences of Febrile Seizures

University of Oulu

Status and phase: Completed; Phase 4

Conditions: Recurrence of Febrile Seizure

Treatments: Drug: Diclofenac, Paracetamol, Ibuprofen

Study type: Interventional

Funder types: Other

Identifiers

NCT00568217

K56721

fs07hr

Details and patient eligibility

About

We wanted to find out if the early use of antipyretics is capable in preventing recurrences of febrile seizures. When a child has had his/her first febrile seizure, the parents were instructed to give him/her antipyretic medication every time when the child had a new episode of fever during two years.

Enrollment: 231 patients

Sex: All

Ages: 3 months to 4 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• First febrile convulsion

Exclusion criteria

• Any prior convulsion or antiepileptic medication

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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231 participants in 5 patient groups, including a placebo group

1 drug

Active Comparator group

Description:

diclofenac 15 mg/kg suppository once

Treatment:

Drug: Diclofenac, Paracetamol, Ibuprofen

2 drug

Placebo Comparator group

Description:

Placebo suppository once

Treatment:

Drug: Diclofenac, Paracetamol, Ibuprofen

3 drug

Active Comparator group

Description:

acetaminophen mixture 15 mg/kg up to four times a day

Treatment:

Drug: Diclofenac, Paracetamol, Ibuprofen

4 drug

Active Comparator group

Description:

ibuprofen mixture 10 mg/kg up to four times a day

Treatment:

Drug: Diclofenac, Paracetamol, Ibuprofen

5 drug

Placebo Comparator group

Description:

oral placebo mixture up to four times a day

Treatment:

Drug: Diclofenac, Paracetamol, Ibuprofen