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Antipyretics for Preventing Recurrences of Febrile Seizures

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ClinicalTrials.gov Identifier: NCT00568217
Recruitment Status : Completed
First Posted : December 5, 2007
Last Update Posted : December 11, 2007
Sponsor:
Information provided by:
University of Oulu

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.

Condition or disease Intervention/treatment Phase
Recurrence of Febrile Seizure Drug: Diclofenac, Paracetamol, Ibuprofen Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 231 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Antipyretics for Preventing Recurrences of Febrile Seizures
Study Start Date : September 1997
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Seizures

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. recurrence of febrile seizure [ Time Frame: two years ]

Secondary Outcome Measures :
  1. we only had the primary outcome measure [ Time Frame: two years ]


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Ages Eligible for Study:   3 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • First febrile convulsion

Exclusion Criteria:

  • Any prior convulsion or antiepileptic medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00568217


Locations
Finland
Heikki Rantala
Oulu, Finland, 90014
Sponsors and Collaborators
University of Oulu
Investigators
Principal Investigator: Heikki Rantala, Professor University of Oulu

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
First Posted: December 5, 2007    Key Record Dates
Last Update Posted: December 11, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Seizures
Fever
Seizures, Febrile
Recurrence
Disease Attributes
Pathologic Processes
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Body Temperature Changes
Ibuprofen
Diclofenac
Acetaminophen
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action