FeverEarly Phase 1NCT04123717
Pilot Study Comparison Of Intravenous Ibuprofen And Intravenous Paracetamol In Management Of Pediatric Fever
A Early Phase 1 study testing Intravenous Ibuprofen in people with Fever, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Fever is one of the most common reasons children are brought to emergency departments. Treatment of fever with antipyretics is usually done simply to make children more comfortable, although in some circumstances, such as febrile seizure, control of fever is critically important. Read more about this study
- Who is it for?
- Ages 6 months to 14 years
- Conditions the study is for
- Fever
- What is being tested?
- Intravenous Ibuprofen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteQatar
- Study dates
- 11 Oct 2019to 7 Mar 2024
- Phase
- Early Phase 1
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 6 months to 14 years.
- Fever ≥ 38.3°C
- Admitted to observation unit of Al Saad Pediatric Emergency Center
Who cannot join
- Have inadequate intravenous access
- Have received paracetamol within 4 hours and Ibuprofen within 6 hours before dosing
- Have fever that is chronic or not new in onset in the preceding 7 days; such as fever from rheumatologic conditions, cancer, or fever of unknown origin, and any fever as a result of transfusion of blood products.
- Have any history of allergy or hypersensitivity to NSAIDs, aspirin, Paracetamol, or any component of ibuprofen or .Paracetamol
- Known to have bleeding risk or diathesis such as hemophilia or thrombocytopenia
- Be receiving ongoing or imminent treatment with corticosteroids
Show all 9Show fewer
- Be on dialysis, have oliguria, have impaired renal function or a renal transplant or known renal or hepatic disease
- Be otherwise unsuitable for the study, in the opinion of the Investigator.
- Any investigational drug use within 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Fever is one of the most common reasons children are brought to emergency departments. Treatment of fever with antipyretics is usually done simply to make children more comfortable, although in some circumstances, such as febrile seizure, control of fever is critically important.
The investigators seek to compare the two most widely-used IV antipyretic medications, paracetamol and ibuprofen, in multiple measures of fever control. Although there is much data evaluating adults fever, as well as these medications for analgesia in both children and adults, there is scant published data on the topic: One IV Ibuprofen study of 100 children, and one study of IV paracetamol with 67 children.1,6 Due to the highly limited published data evaluating IV ibuprofen and IV paracetamol for pediatric fever due to infection, the investigators seek to conduct a pilot study in order to know the effect size and accurately estimate a sample size in order to design a full randomized controlled trail.
Read the detailed description
Upon arrival, when patients are found to be febrile, the parent and patient are informed by the treating physician about their study eligibility. They are provided with study information and a consent form, and given the opportunity to discuss the study with a research nurse or assistant.
Within 10 minutes a decision to consent for the study must be made, and if no consent is made the patient is excluded from the study.
After consent into the study, study subjects will be randomized to arm 1,2,3 or 4.
Study Medications: Arm 1,2,3,4:
Will have an intravenous catheter placed by standard method practiced in the Al Saad Pediatric Emergency Center. All febrile patients admitted in the facility have an intravenous catheter placed as a standard practice, so they will not require an IV catheter simply for the purpose of delivering study medications. This will typically be a 24 gauge or 22 gauge angiocatheter, secured with tegaderm and tape. After placement of this IV catheter, the patient will receive the study medication(s).The dosing of these medications, specifically ibuprofen 10 mg/kg and paracetamol 15 mg/kg is standard dosing routinely used in pediatrics.
Arm 1- Patients will receive IV Ibuprofen 10 mg/kg to a maximum of 400 mg intravenously over 15 minutes. This medication will be diluted as per manufacturer instructions with 100 mL normal saline.
Arm 2- Patients will receive 15 mg/kg IV Paracetamol to a maximum of 1000 mg intravenously over 15 minutes. This medication will be diluted as per manufacturer instructions with normal saline.
Arm 3- Patients will receive an infusion of both IV Paracetamol and IV Ibuprofen. They will initially receive IV Ibuprofen as described above. Their IV catheter will then be flushed with 10 ml of normal saline, and the patient will receive IV Paracetamol as described above.
Arm 4- Patients will receive PO ibuprofen given as a 100mg/5ml syrup or 200 mg tablets to a maximum of 400 mg. The treating nurse will ask the parental preference to use syrup or tablets. If they vomit the medication within 15 minutes of administration, another full dose will be administered.
.
- Conditions
- Fever
- Being tested
- Intravenous Ibuprofen
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous IbuprofenDrug
Also called Intravenous Acetaminophen, Intravenous Acetaminophen & Intravenous Brufen, Brufen PO
The treatment phase consists of assignment to a study arm, either IV Ibuprofen, IV Paracetamol, IV paracetamol-Ibuprofen, or PO ibuprofen, and administration of the appropriate medication. The IV medications will be administered over a 15-minute period. The safety of infusion of IVIbuprofen in just 10 minutes has been established, and to infuse over 15 minutes to ensure that IV Paracetamol and IV Ibuprofen have equal infusion times. For IV paracetamol-Ibuprofen, the IV paracetamol-Ibuprofen will be administered as a sequential infusion of IV Ibuprofen over 15 minutes, followed by a flush of the IV line, followed immediately by IV paracetamol infusion over 15 minutes. Oral ibuprofen will be administered as a syrup or tablet based on patient weight and parental preference.
| Study group | Role | What they receive |
|---|---|---|
| Arm1 - IV Ibuprofen | Active comparator | Patients will receive IV Ibuprofen 10 mg/kg to a maximum of 400 mg intravenously over 15 minutes. This medication will be diluted as per manufacturer instructions with 100 ml normal saline. Receives: Drug: Intravenous Ibuprofen |
| Arm 2 -IV Paracetamol | Active comparator | Patients will receive 15 mg/kg IV Paracetamol to a maximum of 1000 mg intravenously over 15 minutes. This medication will be diluted as per manufacturer instructions with normal saline. Receives: Drug: Intravenous Ibuprofen |
| Arm 3- Both IV Paracetamol and IV Ibuprofen | Active comparator | Patients will receive an infusion of both IV Paracetamol and IV Ibuprofen. They will initially receive IV Ibuprofen and the IV catheter will then be flushed with 10 ml of normal saline, and the patient will receive IV Paracetamol Receives: Drug: Intravenous Ibuprofen |
| Arm 4 -PO Brufen | Active comparator | Patients will receive PO ibuprofen given as a 100mg/5ml syrup or 200 mg tablets to a maximum of 400 mg. The treating nurse will ask the parental preference to use syrup or tablets. If they vomit the medication within 15 minutes of administration, another full dose will be administered. Receives: Drug: Intravenous Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the Area under the curve for fever in the 4 hours after administration of each study arm relative to Area under the curve for fever of Ibuprofen
Area under the curve for fever will be calculated as the difference between measured temperature at a given time and 38°C.
Measured: 4 hours
Secondary outcomes (1)
Afebrile period/time to first fever recurrence
Afebrile period as calculated to be the time from first temperature measurement less than 38°C occurring after fever until the first temperature greater than or equal to 38.3°C occurring after fever.
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start11 Oct 2019
- Primary completion7 Mar 2024
- Study completion7 Mar 2024
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.
- More trials run by Hamad Medical CorporationThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, DR. KHALID AL-ANSARI, Hamad Medical Corporation
- Investigators
- Khalid Alansari, Principal investigator, Hamad Medical Corporation, Doha, Qatar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123717
- Sponsor's protocol ID
- IRB 16206/16
- Status last verified
- Aug 2024
- First submitted
- 7 Oct 2019
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Comparison Of Intravenous Ibuprofen And Intravenous Paracetamol In Management Of Pediatric Fever
- ClinicalTrials.gov ID
- NCT04123717
- Acronym / sponsor ID
- IRB 16206/16
- Conditions
- Fever
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2019 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 11 Oct 2019 (actual)
- 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 reasons children are brought to emergency departments. Treatment of fever with antipyretics is usually done simply to make children more comfortable, although in some circumstances, such as febrile seizure, control of fever is critically important.
The investigators seek to compare the two most widely-used IV antipyretic medications, paracetamol and ibuprofen, in multiple measures of fever control. Although there is much data evaluating adults fever, as well as these medications for analgesia in both children and adults, there is scant published data on the topic: One IV Ibuprofen study of 100 children, and one study of IV paracetamol with 67 children.1,6 Due to the highly limited published data evaluating IV ibuprofen and IV paracetamol for pediatric fever due to infection, the investigators seek to conduct a pilot study in order to know the effect size and accurately estimate a sample size in order to design a full randomized controlled trail.
Detailed description
Upon arrival, when patients are found to be febrile, the parent and patient are informed by the treating physician about their study eligibility. They are provided with study information and a consent form, and given the opportunity to discuss the study with a research nurse or assistant.
Within 10 minutes a decision to consent for the study must be made, and if no consent is made the patient is excluded from the study.
After consent into the study, study subjects will be randomized to arm 1,2,3 or 4.
Study Medications: Arm 1,2,3,4:
Will have an intravenous catheter placed by standard method practiced in the Al Saad Pediatric Emergency Center. All febrile patients admitted in the facility have an intravenous catheter placed as a standard practice, so they will not require an IV catheter simply for the purpose of delivering study medications. This will typically be a 24 gauge or 22 gauge angiocatheter, secured with tegaderm and tape. After placement of this IV catheter, the patient will receive the study medication(s).The dosing of these medications, specifically ibuprofen 10 mg/kg and paracetamol 15 mg/kg is standard dosing routinely used in pediatrics.
Arm 1- Patients will receive IV Ibuprofen 10 mg/kg to a maximum of 400 mg intravenously over 15 minutes. This medication will be diluted as per manufacturer instructions with 100 mL normal saline.
Arm 2- Patients will receive 15 mg/kg IV Paracetamol to a maximum of 1000 mg intravenously over 15 minutes. This medication will be diluted as per manufacturer instructions with normal saline.
Arm 3- Patients will receive an infusion of both IV Paracetamol and IV Ibuprofen. They will initially receive IV Ibuprofen as described above. Their IV catheter will then be flushed with 10 ml of normal saline, and the patient will receive IV Paracetamol as described above.
Arm 4- Patients will receive PO ibuprofen given as a 100mg/5ml syrup or 200 mg tablets to a maximum of 400 mg. The treating nurse will ask the parental preference to use syrup or tablets. If they vomit the medication within 15 minutes of administration, another full dose will be administered.
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm1 - IV Ibuprofen | Active comparator | Drug: Intravenous IbuprofenPatients will receive IV Ibuprofen 10 mg/kg to a maximum of 400 mg intravenously over 15 minutes. This medication will be diluted as per manufacturer instructions with 100 ml normal saline. |
| Arm 2 -IV Paracetamol | Active comparator | Drug: Intravenous IbuprofenPatients will receive 15 mg/kg IV Paracetamol to a maximum of 1000 mg intravenously over 15 minutes. This medication will be diluted as per manufacturer instructions with normal saline. |
| Arm 3- Both IV Paracetamol and IV Ibuprofen | Active comparator | Drug: Intravenous IbuprofenPatients will receive an infusion of both IV Paracetamol and IV Ibuprofen. They will initially receive IV Ibuprofen and the IV catheter will then be flushed with 10 ml of normal saline, and the patient will receive IV Paracetamol |
| Arm 4 -PO Brufen | Active comparator | Drug: Intravenous IbuprofenPatients will receive PO ibuprofen given as a 100mg/5ml syrup or 200 mg tablets to a maximum of 400 mg. The treating nurse will ask the parental preference to use syrup or tablets. If they vomit the medication within 15 minutes of administration, another full dose will be administered. |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients aged 6 months to 14 years.
- Fever ≥ 38.3°C
- Admitted to observation unit of Al Saad Pediatric Emergency Center
Key exclusion criteria (9 listed)
- Have inadequate intravenous access
- Have received paracetamol within 4 hours and Ibuprofen within 6 hours before dosing
- Have fever that is chronic or not new in onset in the preceding 7 days; such as fever from rheumatologic conditions, cancer, or fever of unknown origin, and any fever as a result of transfusion of blood products.
- Have any history of allergy or hypersensitivity to NSAIDs, aspirin, Paracetamol, or any component of ibuprofen or .Paracetamol
- Known to have bleeding risk or diathesis such as hemophilia or thrombocytopenia
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 |
|---|---|---|
| Intravenous IbuprofenAlso: Intravenous Acetaminophen, Intravenous Acetaminophen & Intravenous Brufen, Brufen POThe treatment phase consists of assignment to a study arm, either IV Ibuprofen, IV Paracetamol, IV paracetamol-Ibuprofen, or PO ibuprofen, and administration of the appropriate medication. The IV medications will be administered over a 15-minute period. The safety of infusion of IVIbuprofen in just 10 minutes has been established, and to infuse over 15 minutes to ensure that IV Paracetamol and IV Ibuprofen have equal infusion times. For IV paracetamol-Ibuprofen, the IV paracetamol-Ibuprofen will be administered as a sequential infusion of IV Ibuprofen over 15 minutes, followed by a flush of the IV line, followed immediately by IV paracetamol infusion over 15 minutes. Oral ibuprofen will be administered as a syrup or tablet based on patient weight and parental preference. | Drug | Arm 2 -IV Paracetamol, Arm 3- Both IV Paracetamol and IV Ibuprofen, Arm 4 -PO Brufen, Arm1 - IV Ibuprofen |
Primary outcome
The primary endpoint will be the Area under the curve for fever in the 4 hours after administration of each study arm relative to Area under the curve for fever of Ibuprofen
Time frame: 4 hours
Area under the curve for fever will be calculated as the difference between measured temperature at a given time and 38°C.
1 secondary outcome
Afebrile period/time to first fever recurrence
Time frame: 6 hours
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 14 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Khalid Alansari principal investigator
Hamad Medical Corporation, Doha, Qatar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intravenous Ibuprofen in people with Fever, run by Hamad Medical Corporation at 1 site in Qatar.
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: finished, as of the sponsor's last update on 14 Aug 2024. 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 Qatar. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The primary endpoint will be the Area under the curve for fever in the 4 hours after administration of each study arm relative to Area under the curve for fever of Ibuprofen (time frame: 4 hours). It is what the study was designed to measure, not a finding.
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 14 Aug 2024.