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Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06061575
Enrollment
113
Registered
2023-09-29
Start date
2023-10-31
Completion date
2024-12-01
Last updated
2025-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acetaminophen, Fever, Ibuprofen, Sepsis

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.

Interventions

DRUGAcetaminophen

fever will be managed with acetaminophen

DRUGIbuprofen

fever will be managed with ibuprofen

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Fever30.-60.-120. minutesBody temperature, celcius

Secondary

MeasureTime frameDescription
Heart Rate30.-60.-120. minutesHeart rate per minute
Blood Pressure30.-60.-120. minutesSystolic and diastolic blood pressure in mmHg
Oxygen saturation30.-60.-120. minutesMeasured as a percentage through capillary measurement

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026