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
  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 4

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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
Seizures
Recurrence
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Body Temperature Changes
Signs and Symptoms
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Acetaminophen
Diclofenac
Ibuprofen
Antipyretics
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
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 August 25, 2014