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NCT00568217 Clinical Trial

Antipyretics for Preventing Recurrences of Febrile Seizures

Recurrence of Febrile Seizure Clinical Trial

Official title:
Antipyretics for Preventing Recurrences of Febrile Seizures

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00568217
Other study ID # fs07hr
Secondary ID K56721
Status Completed
Phase Phase 4
First received December 4, 2007
Last updated December 8, 2007
Start date September 1997
Est. completion date August 2005

Study information
Verified date December 2007
Source University of Oulu
Contact n/a
Is FDA regulated No
Health authority Finland: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 231
Est. completion date August 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Months to 4 Years
Eligibility Inclusion Criteria:

- First febrile convulsion

Exclusion Criteria:

- Any prior convulsion or antiepileptic medication

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Drug:
• Diclofenac, Paracetamol, Ibuprofen
Immediately if temperature > 38 degree Celsius, diclofenac suppository 1,5 mg/kg once or placebo suppository After eight hours, if temperature still < 38 degree Celsius, acetaminophen mixture 15 mg/kg up to four times a day, or ibuprofen mixture 10 mg/kg up to four times a day, or placebo mixture up to four times a day as long as temperature < 38 degree Celsius

Locations
Country Name City State
Finland Heikki Rantala Oulu

Sponsors (1)
Lead Sponsor Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome
Type Measure Description Time frame Safety issue
Primary recurrence of febrile seizure two years No
Secondary we only had the primary outcome measure two years No