drugset / Trial / NCT04123717

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

NCT04123717

Phase 0 Completed 147 enrolled Hamad Medical Corporation
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2019-10-11
Primary completion
2024-03-07
Completion
2024-03-07

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 15 mg/kg Intravenous
Comparator Ibuprofen Small molecule 10 mg/kg Intravenous
Comparator Ibuprofen Small molecule 100 mg Intravenous
Comparator Ibuprofen Small molecule 200 mg Intravenous

Indications

No indication recorded.