Antipyretics for Preventing Recurrences of Febrile Seizures - Full Text View

Sponsor:	University of Oulu
Information provided by:	University of Oulu
ClinicalTrials.gov Identifier:	NCT00568217

Purpose

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.

Condition	Intervention	Phase
Recurrence of Febrile Seizure	Drug: Diclofenac, Paracetamol, Ibuprofen	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Official Title:	Antipyretics for Preventing Recurrences of Febrile Seizures

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Fever Seizures

Drug Information available for: Diclofenac sodium Diclofenac potassium Diclofenac Ibuprofen Acetaminophen CT 2584

U.S. FDA Resources

Further study details as provided by University of Oulu:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Enrollment:	231
Study Start Date:	September 1997
Study Completion Date:	August 2005

Arms	Assigned Interventions
Active Comparator: 1 drug diclofenac 15 mg/kg suppository once	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
Placebo Comparator: 2 drug Placebo suppository once	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: 3 drug acetaminophen mixture 15 mg/kg up to four times a day	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: 4 drug ibuprofen mixture 10 mg/kg up to four times a day	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
Placebo Comparator: 5 drug oral placebo mixture up to four times a day	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

Eligibility

Ages Eligible for Study:	3 Months to 4 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

First febrile convulsion

Exclusion Criteria:

Any prior convulsion or antiepileptic medication

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00568217

Locations

Finland
Heikki Rantala
Oulu, Finland, 90014

Sponsors and Collaborators

University of Oulu

Investigators

Principal Investigator:

Heikki Rantala, Professor

University of Oulu

More Information

No publications provided by University of Oulu

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Heikki Rantala, Professor, University of Oulu, Finland
ClinicalTrials.gov Identifier:	NCT00568217 History of Changes
Other Study ID Numbers:	fs07hr, K56721
Study First Received:	December 4, 2007
Last Updated:	December 8, 2007
Health Authority:	Finland: Ethics Committee

Additional relevant MeSH terms:

Seizures, Febrile
Fever
Recurrence
Seizures
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Body Temperature Changes
Signs and Symptoms
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Acetaminophen
Antipyretics

Diclofenac
Ibuprofen
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on February 07, 2012