Antipyretics for Preventing Recurrences of Febrile Seizures

Phase 4

Completed

• Conditions: Recurrence of Febrile Seizure
• Interventions: Drug: Diclofenac, Paracetamol, Ibuprofen

• Registration Number: NCT00568217
• Lead Sponsor: University of Oulu

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-09
• Study Completion: 2005-08
• Status Verified: 2007-12
• Study First Submitted: 2007-12-04
• Study First Submitted QC: 2007-12-04
• Study First Posted: 2007-12-05
• Last Update Submitted: 2007-12-08
• Last Update Posted: 2007-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 231

Inclusion Criteria

• First febrile convulsion

Exclusion Criteria

• Any prior convulsion or antiepileptic medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 drug	Diclofenac, Paracetamol, Ibuprofen	diclofenac 15 mg/kg suppository once
2 drug	Diclofenac, Paracetamol, Ibuprofen	Placebo suppository once
4 drug	Diclofenac, Paracetamol, Ibuprofen	ibuprofen mixture 10 mg/kg up to four times a day
3 drug	Diclofenac, Paracetamol, Ibuprofen	acetaminophen mixture 15 mg/kg up to four times a day
5 drug	Diclofenac, Paracetamol, Ibuprofen	oral placebo mixture up to four times a day

Primary Outcome Measures

Name	Time	Method
recurrence of febrile seizure	two years

Secondary Outcome Measures

Name	Time	Method
we only had the primary outcome measure	two years

Trial Locations

Locations (1)

Heikki Rantala; 🇫🇮 Oulu, Finland