Antipyretics for Preventing Recurrences of Febrile Seizures

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

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

Finland

Heikki Rantala

Oulu, Finland, 90014

Sponsors and Collaborators

University of Oulu

Investigators

• Principal Investigator: Heikki Rantala, Professor; University of Oulu

More Information

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. doi: 10.1001/archpediatrics.2009.137.

• Responsible Party: Heikki Rantala, Professor, University of Oulu, Finland
• ClinicalTrials.gov Identifier: NCT00568217
• Other Study ID Numbers: fs07hr; K56721
• First Posted: December 5, 2007
• Last Update Posted: December 11, 2007
• Last Verified: December 2007

Additional relevant MeSH terms:

Seizures; Seizures, Febrile; Recurrence; Fever; Disease Attributes; Pathologic Processes; Neurologic Manifestations; Nervous System Diseases; Body Temperature Changes; Acetaminophen; Ibuprofen; Diclofenac; 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; Antipyretics