Recurrence of Febrile SeizurePhase 4NCT00568217
Antipyretics for Preventing Recurrences of Febrile Seizures
A Phase 4 study testing Diclofenac, Paracetamol, Ibuprofen in people with Recurrence of Febrile Seizure, run by University of Oulu at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months to 4 years
- Conditions the study is for
- Recurrence of Febrile Seizure
- What is being tested?
- Diclofenac, Paracetamol, Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 231 participants
- Where
- 1 siteFinland
- Study dates
- Sep 1997to Aug 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- First febrile convulsion
Who cannot join
- Any prior convulsion or antiepileptic medication
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Recurrence of Febrile Seizure
- Being tested
- Diclofenac, Paracetamol, Ibuprofen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac, Paracetamol, IbuprofenDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 drug | Active comparator | diclofenac 15 mg/kg suppository once Receives: Drug: Diclofenac, Paracetamol, Ibuprofen |
| 2 drug | Placebo comparator | Placebo suppository once Receives: Drug: Diclofenac, Paracetamol, Ibuprofen |
| 3 drug | Active comparator | acetaminophen mixture 15 mg/kg up to four times a day Receives: Drug: Diclofenac, Paracetamol, Ibuprofen |
| 4 drug | Active comparator | ibuprofen mixture 10 mg/kg up to four times a day Receives: Drug: Diclofenac, Paracetamol, Ibuprofen |
| 5 drug | Placebo comparator | oral placebo mixture up to four times a day Receives: Drug: Diclofenac, Paracetamol, Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of febrile seizure
Measured: two years
Secondary outcomes (1)
we only had the primary outcome measure
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startSep 1997
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Recurrence of Febrile SeizureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 231 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Investigators
- Heikki Rantala, Professor, Principal investigator, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568217
- Sponsor's protocol ID
- fs07hr
- Other IDs
- K56721
- Status last verified
- Dec 2007
- First submitted
- 4 Dec 2007
- Last updated
- 11 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 19736332
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antipyretics for Preventing Recurrences of Febrile Seizures
- ClinicalTrials.gov ID
- NCT00568217
- Acronym / sponsor ID
- fs07hr
- Conditions
- Recurrence of Febrile Seizure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 231 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- Sep 1997
- Study completion
- Aug 2005 (actual)
- First posted
- 5 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 drug | Active comparator | Drug: Diclofenac, Paracetamol, Ibuprofendiclofenac 15 mg/kg suppository once |
| 2 drug | Placebo comparator | Drug: Diclofenac, Paracetamol, IbuprofenPlacebo suppository once |
| 3 drug | Active comparator | Drug: Diclofenac, Paracetamol, Ibuprofenacetaminophen mixture 15 mg/kg up to four times a day |
| 4 drug | Active comparator | Drug: Diclofenac, Paracetamol, Ibuprofenibuprofen mixture 10 mg/kg up to four times a day |
| 5 drug | Placebo comparator | Drug: Diclofenac, Paracetamol, Ibuprofenoral placebo mixture up to four times a day |
Who may qualify
- Ages
- 3 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- First febrile convulsion
Key exclusion criteria (1 listed)
- Any prior convulsion or antiepileptic medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac, Paracetamol, IbuprofenImmediately 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 | Drug | 1 drug, 2 drug, 3 drug, 4 drug, 5 drug |
Primary outcome
recurrence of febrile seizure
Time frame: two years
1 secondary outcome
we only had the primary outcome measure
Time frame: two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2007.
- Derived from this study: PubMed 19736332Strengell 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heikki Rantala, Professor principal investigator
University of Oulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diclofenac, Paracetamol, Ibuprofen in people with Recurrence of Febrile Seizure, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrence of febrile seizure (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00568217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2007.