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

Hamad Medical Corporation (HMC)

Status and phase: Completed; Early Phase 1

Conditions: Fever

Treatments: Drug: Intravenous Ibuprofen

Study type: Interventional

Funder types: Industry

Identifiers

NCT04123717

IRB 16206/16

Details and patient eligibility

About

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.

Full 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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Enrollment: 147 patients

Sex: All

Ages: 6 months to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 4 patient groups

Arm1 - IV Ibuprofen

Active Comparator group

Description:

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.

Treatment:

Drug: Intravenous Ibuprofen

Arm 2 -IV Paracetamol

Active Comparator group

Description:

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.

Treatment:

Drug: Intravenous Ibuprofen

Arm 3- Both IV Paracetamol and IV Ibuprofen

Active Comparator group

Description:

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

Treatment:

Drug: Intravenous Ibuprofen

Arm 4 -PO Brufen

Active Comparator group

Description:

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.

Treatment:

Drug: Intravenous Ibuprofen