FeverNCT00389272
Adding a Second Drug for Febrile Children Treated With Acetaminophen
A study testing Ibuprofen, acetaminophen in people with Fever, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Fever is one of the most common symptoms in pediatrics and one of the most common reasons for visits in pediatricians' office and pediatric emergency departments. Many parents consider fever to be the most terrifying symptom. Acetaminophen and ibuprofen are both effective and safe treatments for febrile children. Read more about this study
- Who is it for?
- Ages 6 months to 4 years
- Conditions the study is for
- Fever
- What is being tested?
- Ibuprofen, acetaminophen
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2005to Dec 2008
- Phase
- Interventional
- 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 6 months to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 6 mo- 4 years
- Rectal temperature > 38.5
- Received 10-15 mg/kg of acetaminophen or 5-10 mg/kg of ibuprofen 1.5 - 3.5 hours before admission to the
Who cannot join
- Received more than 75 mg acetaminophen in the last 24 hours
- Unable to take oral medications
- Hypersensitivity to acetaminophen or ibuprofen
- Varicella
- Renal failure
- Liver disease
Show all 9Show fewer
- Rectal temperature can't be measured (due to anatomical or medical problem)
- Received both Ibuprofen and acetaminophen in the last 6 hours
- Informed consent could not be granted
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Pediatric Emergency Medicine Service, Assaf Harofeh Medical Center
Tsrifin, 70300
Eran Kozer, MD
About this study
Fever is one of the most common symptoms in pediatrics and one of the most common reasons for visits in pediatricians' office and pediatric emergency departments. Many parents consider fever to be the most terrifying symptom.
Acetaminophen and ibuprofen are both effective and safe treatments for febrile children. In order to achieve better temperature control and to avoid toxicity it has been suggested to treat febrile children with alternating doses of acetaminophen and ibuprofen. Surveys in the USA and Spain found that this practice is very common. However, The safety and efficacy of such practice was never described.
Read more
Hypothesis:
Children who are still febrile after being treated with acetaminophen or ibuprofen will have greater temperature decrement if treated with another drug (acetaminophen for those treated with ibuprofen and ibuprofen for those treated with acetaminophen) than if treated with placebo.
Read the detailed description
Methods:
Design: randomized double blind placebo controlled study. Setting: The ED and pediatric ward of a large University affiliated Hospital
Participants:
Inclusion criteria:
- Age: 6 mo- 4 years
- Rectal temperature > 38.5
- Received 10-15 mg/kg of acetaminophen or 5-10 mg/kg of ibuprofen 1.5 - 3.5 hours before admission to the ED.
Exclusion criteria:
- Received more than 75 mg acetaminophen in the last 24 hours
- Unable to take oral medications
- Hypersensitivity to acetaminophen or ibuprofen
- Varicella
- Renal failure
- Liver disease
- Rectal temperature can't be measured (due to anatomical or medical problem)
- Received both Ibuprofen and acetaminophen in the last 6 hours
- Informed consent could not be granted
Intervention:
Patients will be recruited in the ED and pediatric ward at Assaf Harofeh Medical Center. Legal guardians of eligible patients will be approached for consent. After obtaining informed consent a detailed history regarding the way fever was managed during the current illness will be collected (appendix 1). Patients will be randomized in a ratio of 2:1 (by a computer generated list of random numbers) into one of two groups. Group A will be treated with oral suspension of ibuprofen 10mg/kg (if the patient received acetaminophen at home) or oral suspension of acetaminophen 15 mg/kg (if treated previously with ibuprofen). The second group will be treated with the same amount of oral placebo suspension. The parents and the physician will be blinded to the treatment given. Body departure will be recoded at base line and at 15, 30, 60, 90, 120, 180 minutes after the drug administration. Blood sample for serum concentrations of acetaminophen or/and ibuprofen will be taken at the time of routine blood sampling according to the attending physician decision. Serum concentrations will not be measured if the attending physician decides that blood tests are not indicated.
Primary outcome:
- Maximal change in temperature during the 3-hour period after enrollment.
Secondary endpoints:
- Proportion of patients with a drop of at least 1°C and 2°C in mean temperature at the end of the study (3 hours).
- Decrement in fever at each time point, and the area under the temperature (versus time) curve for each group, calculated using the trapezoidal method. Continuous outcomes
- Proportion of patients with temperature < 38 at the end of the study (3 hours).
- Conditions
- Fever
- Being tested
- Ibuprofen, acetaminophen
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen, acetaminophenDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2006 (estimated)
- Study startSep 2005
- Study completionDec 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FeverStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Investigators
- Eran Kozer, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389272
- Sponsor's protocol ID
- 53/05
- Status last verified
- Oct 2006
- First submitted
- 17 Oct 2006
- Last updated
- 31 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding a Second Drug for Febrile Children Treated With Acetaminophen
- ClinicalTrials.gov ID
- NCT00389272
- Acronym / sponsor ID
- 53/05
- Conditions
- Fever
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Sep 2005
- Study completion
- Dec 2008 (estimated)
- First posted
- 18 Oct 2006 (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.
Fever is one of the most common symptoms in pediatrics and one of the most common reasons for visits in pediatricians' office and pediatric emergency departments. Many parents consider fever to be the most terrifying symptom.
Acetaminophen and ibuprofen are both effective and safe treatments for febrile children. In order to achieve better temperature control and to avoid toxicity it has been suggested to treat febrile children with alternating doses of acetaminophen and ibuprofen. Surveys in the USA and Spain found that this practice is very common. However, The safety and efficacy of such practice was never described.
Hypothesis:
Children who are still febrile after being treated with acetaminophen or ibuprofen will have greater temperature decrement if treated with another drug (acetaminophen for those treated with ibuprofen and ibuprofen for those treated with acetaminophen) than if treated with placebo.
Detailed description
Methods:
Design: randomized double blind placebo controlled study. Setting: The ED and pediatric ward of a large University affiliated Hospital
Participants:
Inclusion criteria:
- Age: 6 mo- 4 years
- Rectal temperature > 38.5
- Received 10-15 mg/kg of acetaminophen or 5-10 mg/kg of ibuprofen 1.5 - 3.5 hours before admission to the ED.
Exclusion criteria:
- Received more than 75 mg acetaminophen in the last 24 hours
- Unable to take oral medications
- Hypersensitivity to acetaminophen or ibuprofen
- Varicella
- Renal failure
- Liver disease
- Rectal temperature can't be measured (due to anatomical or medical problem)
- Received both Ibuprofen and acetaminophen in the last 6 hours
- Informed consent could not be granted
Intervention:
Patients will be recruited in the ED and pediatric ward at Assaf Harofeh Medical Center. Legal guardians of eligible patients will be approached for consent. After obtaining informed consent a detailed history regarding the way fever was managed during the current illness will be collected (appendix 1). Patients will be randomized in a ratio of 2:1 (by a computer generated list of random numbers) into one of two groups. Group A will be treated with oral suspension of ibuprofen 10mg/kg (if the patient received acetaminophen at home) or oral suspension of acetaminophen 15 mg/kg (if treated previously with ibuprofen). The second group will be treated with the same amount of oral placebo suspension. The parents and the physician will be blinded to the treatment given. Body departure will be recoded at base line and at 15, 30, 60, 90, 120, 180 minutes after the drug administration. Blood sample for serum concentrations of acetaminophen or/and ibuprofen will be taken at the time of routine blood sampling according to the attending physician decision. Serum concentrations will not be measured if the attending physician decides that blood tests are not indicated.
Primary outcome:
- Maximal change in temperature during the 3-hour period after enrollment.
Secondary endpoints:
- Proportion of patients with a drop of at least 1°C and 2°C in mean temperature at the end of the study (3 hours).
- Decrement in fever at each time point, and the area under the temperature (versus time) curve for each group, calculated using the trapezoidal method. Continuous outcomes
- Proportion of patients with temperature < 38 at the end of the study (3 hours).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 6 mo- 4 years
- Rectal temperature > 38.5
- Received 10-15 mg/kg of acetaminophen or 5-10 mg/kg of ibuprofen 1.5 - 3.5 hours before admission to the
Key exclusion criteria (9 listed)
- Received more than 75 mg acetaminophen in the last 24 hours
- Unable to take oral medications
- Hypersensitivity to acetaminophen or ibuprofen
- Varicella
- Renal failure
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 |
|---|---|---|
| Ibuprofen, acetaminophen | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2007.
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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.
Eran Kozer principal investigator
Assaf-Harofeh Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen, acetaminophen in people with Fever, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 31 Oct 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eran Kozer, MD (972 8 9779916, erank@asaf.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 31 Oct 2007.