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Sponsored by: |
University of Oulu |
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Information provided by: | University of Oulu |
ClinicalTrials.gov Identifier: | NCT00568217 |
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 |
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
|
Ages Eligible for Study: | 3 Months to 4 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Anti-Inflammatory Agents Ibuprofen Cyclooxygenase Inhibitors Seizures Seizures, Febrile Central Nervous System Diseases Diclofenac Brain Diseases Recurrence Fever |
Signs and Symptoms Analgesics, Non-Narcotic Epilepsy Neurologic Manifestations Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Acetaminophen |
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 |