Back to resultsAntipyretics for Preventing Recurrences of Febrile Seizures
Primary Purpose
Recurrence of Febrile Seizure
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Diclofenac, Paracetamol, Ibuprofen
Sponsored by
About this trial
This is an interventional prevention trial for Recurrence of Febrile Seizure
Eligibility Criteria
Inclusion Criteria:
- First febrile convulsion
Exclusion Criteria:
- Any prior convulsion or antiepileptic medication
Sites / Locations
- Heikki Rantala
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Placebo Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1 drug
2 drug
3 drug
4 drug
5 drug
Arm Description
diclofenac 15 mg/kg suppository once
Placebo suppository once
acetaminophen mixture 15 mg/kg up to four times a day
ibuprofen mixture 10 mg/kg up to four times a day
oral placebo mixture up to four times a day
Outcomes
Primary Outcome Measures
recurrence of febrile seizure
Secondary Outcome Measures
we only had the primary outcome measure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00568217
Brief Title
Antipyretics for Preventing Recurrences of Febrile Seizures
Official Title
Antipyretics for Preventing Recurrences of Febrile Seizures
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
September 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oulu
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrence of Febrile Seizure
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
231 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 drug
Arm Type
Active Comparator
Arm Description
diclofenac 15 mg/kg suppository once
Arm Title
2 drug
Arm Type
Placebo Comparator
Arm Description
Placebo suppository once
Arm Title
3 drug
Arm Type
Active Comparator
Arm Description
acetaminophen mixture 15 mg/kg up to four times a day
Arm Title
4 drug
Arm Type
Active Comparator
Arm Description
ibuprofen mixture 10 mg/kg up to four times a day
Arm Title
5 drug
Arm Type
Placebo Comparator
Arm Description
oral placebo mixture up to four times a day
Intervention Type
Drug
Intervention Name(s)
Diclofenac, Paracetamol, Ibuprofen
Intervention Description
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
Primary Outcome Measure Information:
Title
recurrence of febrile seizure
Time Frame
two years
Secondary Outcome Measure Information:
Title
we only had the primary outcome measure
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
First febrile convulsion
Exclusion Criteria:
Any prior convulsion or antiepileptic medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heikki Rantala, Professor
Organizational Affiliation
University of Oulu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heikki Rantala
City
Oulu
ZIP/Postal Code
90014
Country
Finland
12. IPD Sharing Statement
Citations:
PubMed Identifier
19736332
Citation
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.
Results Reference
derived
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Antipyretics for Preventing Recurrences of Febrile Seizures
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