Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients: A Randomized Double-Blind Controlled Study

Ankara City Hospital Bilkent1 site in 1 country113 target enrollmentOctober 31, 2023

Overview

Brief Summary

This is a randomized double-blind controlled study with the primary aim of scientifically evaluating the potential effects of paracetamol and ibuprofen in the management of sepsis by comparing their fever-reducing efficacy in septic patients. Sepsis is recognized as a severe form of systemic inflammatory response syndrome (SIRS) characterized by organ dysfunction resulting from severe infections. This study aims to address a significant aspect of fever management in septic patients by objectively assessing the fever-reducing potential of paracetamol and ibuprofen.

Detailed Description

This is a randomized double-blind controlled study with the primary aim of scientifically evaluating the potential effects of paracetamol and ibuprofen in the management of sepsis by comparing their fever-reducing efficacy in septic patients. Sepsis is recognized as a severe form of systemic inflammatory response syndrome (SIRS) characterized by organ dysfunction resulting from severe infections. This study aims to address a significant aspect of fever management in septic patients by objectively assessing the fever-reducing potential of paracetamol and ibuprofen. In addition to assessing the fever-reducing efficacy of paracetamol and ibuprofen, this study will also evaluate their ability to provide symptomatic relief. The effects of paracetamol and ibuprofen on vital signs in septic patients will be examined to understand the overall course of the clinical condition. The analysis of the side effect profile aims to provide a comprehensive view of the safety and tolerability of both drugs. The significance of this study can be explained by the critical role of fever regulation in sepsis management. Commonly used drugs like paracetamol and ibuprofen are widely employed to reduce fever and alleviate symptoms. However, there is limited data regarding the efficacy and safety of these drugs in septic patients. This research will help us better understand the role of these drugs in fever management in septic patients and contribute to optimizing treatment strategies. The findings of this study may guide clinical practice and establish a stronger scientific foundation for the management of septic patients. This research may bring a new perspective to clinical practices regarding fever management in septic patients. By providing scientific data on whether commonly used drugs like paracetamol and ibuprofen can contribute to sepsis treatment, it may enhance the more effective management of patients. If it is demonstrated that paracetamol and ibuprofen can be used effectively and safely in septic patients, treatment optimization can be achieved with appropriate dosages and under suitable conditions. This may enable patients to achieve more effective fever control. The results of the research may offer a better scientific basis for the use of drugs like paracetamol and ibuprofen in septic patients in clinical settings.

Registry

clinicaltrials.gov

Start Date

October 31, 2023

End Date

December 1, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Ankara City Hospital Bilkent

Responsible Party

Principal Investigator

Safa Dönmez

M.D.

Ankara City Hospital Bilkent

Eligibility Criteria

Inclusion Criteria

•18 years of age or older
•Under 80 years of age
•Willing to participate in the study
•Diagnosed with sepsis according to the latest current guidelines
•Having a fever \>38.3°C
•With no known history of adverse reactions to the active ingredient of the medication to be used"

Exclusion Criteria

•Under 18 years of age or over 80 years of age
•Not willing to participate in the study
•With a known history of adverse reactions to study medications
•Having a fever \<38.3°C
•Pregnant individuals
•Individuals with advanced systemic illness
•Those with malignancies
•Patients with chronic liver and kidney disease
•Using sedative and analgesic neuro-psychiatric drugs
•With a history of psychological and neurological diseases"

Arms & Interventions

Acetaminophen

Adult patients diagnosed with sepsis according to the latest current guidelines, who have agreed to participate in the study or have provided consent by their relatives, and received 1g of acetaminophen for fever management.

Intervention: Acetaminophen

Ibuprofen

Adult patients diagnosed with sepsis according to the latest current guidelines, who have agreed to participate in the study or have provided consent by their relatives, and received 400 mg of ıbuprofen for fever management.

Intervention: Ibuprofen