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Antipyretics for Preventing Recurrences of Febrile Seizures

NCT ID: NCT00568217

Last Updated: 2007-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

231 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-09-30

Study Completion Date

2005-08-31

Brief Summary

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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

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Conditions

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Recurrence of Febrile Seizure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1 drug

diclofenac 15 mg/kg suppository once

Group Type ACTIVE_COMPARATOR

Diclofenac, Paracetamol, Ibuprofen

Intervention Type DRUG

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

2 drug

Placebo suppository once

Group Type PLACEBO_COMPARATOR

Diclofenac, Paracetamol, Ibuprofen

Intervention Type DRUG

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

3 drug

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

Group Type ACTIVE_COMPARATOR

Diclofenac, Paracetamol, Ibuprofen

Intervention Type DRUG

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

4 drug

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

Group Type ACTIVE_COMPARATOR

Diclofenac, Paracetamol, Ibuprofen

Intervention Type DRUG

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

5 drug

oral placebo mixture up to four times a day

Group Type PLACEBO_COMPARATOR

Diclofenac, Paracetamol, Ibuprofen

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* First febrile convulsion

Exclusion Criteria

* Any prior convulsion or antiepileptic medication
Minimum Eligible Age

3 Months

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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University of Oulu, Finland

Principal Investigators

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Heikki Rantala, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Oulu

Locations

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Heikki Rantala

Oulu, , Finland

Site Status

Countries

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Finland

References

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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. doi: 10.1001/archpediatrics.2009.137.

Reference Type DERIVED
PMID: 19736332 (View on PubMed)

Other Identifiers

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K56721

Identifier Type: -

Identifier Source: secondary_id

fs07hr

Identifier Type: -

Identifier Source: org_study_id