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

• Status: Recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamad Medical Corporation
• Treatments: Acetaminophen; Ibuprofen

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.