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Pilot Study Comparison Of Intravenous Ibuprofen And Intravenous Paracetamol In Management Of Pediatric Fever

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ClinicalTrials.gov Identifier: NCT04123717
Recruitment Status : Recruiting
First Posted : October 11, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
DR. KHALID AL-ANSARI, Hamad Medical Corporation

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Fever Drug: Intravenous Ibuprofen Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Comparison Of Intravenous Ibuprofen And Intravenous Paracetamol In Management Of Pediatric Fever
Actual Study Start Date : October 11, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

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.
Drug: Intravenous Ibuprofen
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:
  • Intravenous Acetaminophen
  • Intravenous Acetaminophen & Intravenous Brufen
  • Brufen PO

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.
Drug: Intravenous Ibuprofen
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:
  • Intravenous Acetaminophen
  • Intravenous Acetaminophen & Intravenous Brufen
  • Brufen PO

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
Drug: Intravenous Ibuprofen
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:
  • Intravenous Acetaminophen
  • Intravenous Acetaminophen & Intravenous Brufen
  • Brufen PO

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.
Drug: Intravenous Ibuprofen
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:
  • Intravenous Acetaminophen
  • Intravenous Acetaminophen & Intravenous Brufen
  • Brufen PO




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   6 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients aged 6 months to 14 years.
  2. Fever ≥ 38.3°C
  3. Admitted to observation unit of Al Saad Pediatric Emergency Center

Exclusion Criteria:

  1. Have inadequate intravenous access
  2. Have received paracetamol within 4 hours and Ibuprofen within 6 hours before dosing
  3. 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.
  4. Have any history of allergy or hypersensitivity to NSAIDs, aspirin, Paracetamol, or any component of ibuprofen or .Paracetamol
  5. Known to have bleeding risk or diathesis such as hemophilia or thrombocytopenia
  6. Be receiving ongoing or imminent treatment with corticosteroids
  7. Be on dialysis, have oliguria, have impaired renal function or a renal transplant or known renal or hepatic disease
  8. Be otherwise unsuitable for the study, in the opinion of the Investigator.
  9. Any investigational drug use within 30 days prior to enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04123717


Contacts
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Contact: Dr. Khalid Alansari 55656661 kalansari1@hamad.qa

Locations
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Qatar
Hamad Medical Corporation Recruiting
Doha, Qatar, 3050
Contact: Dr.Khalid Alansari    55656661    kalansari1@hamad.qa   
Sponsors and Collaborators
Hamad Medical Corporation
Investigators
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Principal Investigator: Khalid Alansari Hamad Medical Corporation, Doha, Qatar

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Responsible Party: DR. KHALID AL-ANSARI, Director of Pediatric Emergency Center's, Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT04123717     History of Changes
Other Study ID Numbers: IRB 16206/16
First Posted: October 11, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fever
Body Temperature Changes
Signs and Symptoms
Acetaminophen
Ibuprofen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action