- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04123717
Pilot Study Comparison Of Intravenous Ibuprofen And Intravenous Paracetamol In Management Of Pediatric Fever
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.
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Early Phase 1
Contacts and Locations
Study Contact
- Name: Dr. Khalid Alansari
- Phone Number: 55656661
- Email: kalansari1@hamad.qa
Study Locations
-
-
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Doha, Qatar, 3050
- Recruiting
- Hamad medical corporation
-
Contact:
- Dr.Khalid Alansari
- Phone Number: 55656661
- Email: kalansari1@hamad.qa
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged 6 months to 14 years.
- Fever ≥ 38.3°C
- Admitted to observation unit of Al Saad Pediatric Emergency Center
Exclusion Criteria:
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Arm1 - IV Ibuprofen
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.
|
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.
Other Names:
|
Active Comparator: Arm 2 -IV Paracetamol
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.
|
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.
Other Names:
|
Active Comparator: Arm 3- Both IV Paracetamol and IV Ibuprofen
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
|
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.
Other Names:
|
Active Comparator: Arm 4 -PO Brufen
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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Afebrile period/time to first fever recurrence
Time Frame: 6 hours
|
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.
|
6 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Febrile seizure occuring within 24 hours of study enrollment
Time Frame: 24 hours
|
Safety and tolerability of IV Ibuprofen, IV Paracetamol, IV paracetamol-Ibuprofen, and PO ibuprofen based on Adverse Events
|
24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Khalid Alansari, Hamad Medical Corporation, Doha, Qatar
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Body Temperature Changes
- Fever
- 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
- Ibuprofen
Other Study ID Numbers
- IRB 16206/16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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