Status:

COMPLETED

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

Lead Sponsor:

Hamad Medical Corporation

Conditions:

Fever

Eligibility:

All Genders

6-14 years

Phase:

EARLY_PHASE1

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 c...

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...

Eligibility Criteria

Inclusion

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

Exclusion

  • 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.

Key Trial Info

Start Date :

October 11 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 7 2024

Estimated Enrollment :

147 Patients enrolled

Trial Details

Trial ID

NCT04123717

Start Date

October 11 2019

End Date

March 7 2024

Last Update

August 14 2024

Active Locations (1)

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1

Hamad Medical Corporation

Doha, Qatar, 3050