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

December 4, 2007
December 8, 2007
September 1997
Not Provided
recurrence of febrile seizure [ Time Frame: two years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00568217 on ClinicalTrials.gov Archive Site
we only had the primary outcome measure [ Time Frame: two years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Antipyretics for Preventing Recurrences of Febrile Seizures
Antipyretics for Preventing Recurrences of Febrile Seizures

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Recurrence of Febrile Seizure
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
  • 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
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.
 
Completed
231
August 2005
Not Provided

Inclusion Criteria:

  • First febrile convulsion

Exclusion Criteria:

  • Any prior convulsion or antiepileptic medication
Both
3 Months to 4 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00568217
fs07hr, K56721
No
Heikki Rantala, Professor, University of Oulu, Finland
University of Oulu
Not Provided
Principal Investigator: Heikki Rantala, Professor University of Oulu
University of Oulu
December 2007

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