Antipyretics for Preventing Recurrences of Febrile Seizures

This study has been completed.

Sponsor:

Information provided by:

University of Oulu

ClinicalTrials.gov Identifier:

NCT00568217

First received: December 4, 2007

Last updated: December 8, 2007

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

December 4, 2007

Last Updated Date

December 8, 2007

Start Date ^ICMJE

September 1997

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

recurrence of febrile seizure [ Time Frame: two years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00568217 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

we only had the primary outcome measure [ Time Frame: two years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Antipyretics for Preventing Recurrences of Febrile Seizures

Official Title ^ICMJE

Antipyretics for Preventing Recurrences of Febrile Seizures

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Recurrence of Febrile Seizure

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: 1 drug
diclofenac 15 mg/kg suppository once

Intervention: Drug: Diclofenac, Paracetamol, Ibuprofen
Placebo Comparator: 2 drug
Placebo suppository once

Intervention: Drug: Diclofenac, Paracetamol, Ibuprofen
Active Comparator: 3 drug
acetaminophen mixture 15 mg/kg up to four times a day

Intervention: Drug: Diclofenac, Paracetamol, Ibuprofen
Active Comparator: 4 drug
ibuprofen mixture 10 mg/kg up to four times a day

Intervention: Drug: Diclofenac, Paracetamol, Ibuprofen
Placebo Comparator: 5 drug
oral placebo mixture up to four times a day

Intervention: Drug: Diclofenac, Paracetamol, Ibuprofen

Publications *

Strengell T, Uhari M, Tarkka R, Uusimaa J, Alen R, Lautala P, Rantala H. Antipyretic agents for preventing recurrences of febrile seizures: randomized controlled trial. Arch Pediatr Adolesc Med. 2009 Sep;163(9):799-804.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

231

Completion Date

August 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

First febrile convulsion

Exclusion Criteria:

Any prior convulsion or antiepileptic medication

Gender

Both

Ages

3 Months to 4 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT00568217

Other Study ID Numbers ^ICMJE

fs07hr, K56721

Has Data Monitoring Committee

Responsible Party

Heikki Rantala, Professor, University of Oulu, Finland

Study Sponsor ^ICMJE

University of Oulu

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Heikki Rantala, Professor

University of Oulu

Information Provided By

University of Oulu

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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