Antipyretics for Preventing Recurrences of Febrile Seizures

Study Overview
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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.

Official Title
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Antipyretics for Preventing Recurrences of Febrile Seizures

Conditions
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Recurrence of Febrile Seizure

Intervention / Treatment
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* Drug: Diclofenac, Paracetamol, Ibuprofen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First febrile convulsion Exclusion Criteria: Any prior convulsion or antiepileptic medication

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 drug<br>diclofenac 15 mg/kg suppository once | Drug: Diclofenac, Paracetamol, Ibuprofen<br>* 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<br>|
| Placebo Comparator: 2 drug<br>Placebo suppository once | Drug: Diclofenac, Paracetamol, Ibuprofen<br>* 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<br>|
| Active Comparator: 3 drug<br>acetaminophen mixture 15 mg/kg up to four times a day | Drug: Diclofenac, Paracetamol, Ibuprofen<br>* 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<br>|
| Active Comparator: 4 drug<br>ibuprofen mixture 10 mg/kg up to four times a day | Drug: Diclofenac, Paracetamol, Ibuprofen<br>* 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<br>|
| Placebo Comparator: 5 drug<br>oral placebo mixture up to four times a day | Drug: Diclofenac, Paracetamol, Ibuprofen<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence of febrile seizure |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| we only had the primary outcome measure |  | two years |