Pilot Study Comparison Of Intravenous Ibuprofen And Intravenous Paracetamol In Management Of Pediatric Fever
Keywords
Abstract
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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Dates
| Last Verified: | 09/30/2019 |
| First Submitted: | 10/06/2019 |
| Estimated Enrollment Submitted: | 10/09/2019 |
| First Posted: | 10/10/2019 |
| Last Update Submitted: | 10/13/2019 |
| Last Update Posted: | 10/14/2019 |
| Actual Study Start Date: | 10/10/2019 |
| Estimated Primary Completion Date: | 12/30/2020 |
| Estimated Study Completion Date: | 01/31/2021 |
Condition or disease
Intervention/treatment
Drug: Intravenous Ibuprofen
Phase
Arm Groups
| 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. | |
| 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. | |
| 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 | |
| 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. |
Eligibility Criteria
| Ages Eligible for Study | 6 Months To 6 Months |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
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 [4 hours]
Secondary Outcome Measures
1. Afebrile period/time to first fever recurrence [6 hours]
Other Outcome Measures
1. Febrile seizure occuring within 24 hours of study enrollment [24 hours]
