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:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
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
1 drug: Active Comparator 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
2 drug: Placebo Comparator 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
3 drug: Active Comparator 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
4 drug: Active Comparator 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
5 drug: Placebo Comparator 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 National Clinical Trials Identifier (NCT ID):

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Body Temperature Changes
Brain Diseases
Fever
Signs and Symptoms
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Acetaminophen
Ibuprofen

Cyclooxygenase Inhibitors
Nervous System Diseases
Seizures
Seizures, Febrile
Central Nervous System Diseases
Diclofenac
Enzyme Inhibitors
Recurrence
Pharmacologic Actions
Epilepsy
Analgesics, Non-Narcotic
Neurologic Manifestations
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010