Antipyretics for Preventing Recurrences of Febrile Seizures

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.

Study Overview

• Status: Completed
• Conditions: Recurrence of Febrile Seizure
• Intervention / Treatment: Drug: Diclofenac, Paracetamol, Ibuprofen

• Study Type: Interventional
• Enrollment (Actual): 231
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90014
    • Heikki Rantala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• First febrile convulsion

Exclusion Criteria:

• Any prior convulsion or antiepileptic medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
recurrence of febrile seizure	two years

Secondary Outcome Measures

Outcome Measure	Time Frame
we only had the primary outcome measure	two years

Collaborators and Investigators

• Sponsor: University of Oulu
• Investigators: Principal Investigator: Heikki Rantala, Professor, University of Oulu

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 1997
• Study Completion (Actual): August 1, 2005

Study Registration Dates

• First Submitted: December 4, 2007
• First Submitted That Met QC Criteria: December 4, 2007
• First Posted (Estimate): December 5, 2007

Study Record Updates

• Last Update Posted (Estimate): December 11, 2007
• Last Update Submitted That Met QC Criteria: December 8, 2007
• Last Verified: December 1, 2007

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Disease Attributes; Body Temperature Changes; Heat Stress Disorders; Recurrence; Seizures; Hyperthermia; Fever; Seizures, Febrile; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Diclofenac; Ibuprofen
• Other Study ID Numbers: fs07hr; K56721