Clinical trial
Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis Patients: A Randomized Double-Blind Controlled Study
Name
Management of Fever in Sepsis
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.
Trial arms
Trial start
2023-10-31
Estimated PCD
2024-10-31
Trial end
2024-12-01
Status
Recruiting
Phase
Early phase I
Treatment
Acetaminophen
fever will be managed with acetaminophen
Arms:
Acetaminophen
Other names:
Acetaminophen 1gr
Ibuprofen
fever will be managed with ibuprofen
Arms:
Ibuprofen
Other names:
Ibuprofen 400 mg
Size
84
Primary endpoint
Fever
30.-60.-120. minutes
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°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°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"
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 84, 'type': 'ESTIMATED'}}
Updated at
2024-01-08
1 organization
2 products
4 indications
Organization
Ankara City Hospital BilkentProduct
AcetaminophenIndication
SepsisIndication
ParacetamolIndication
FeverIndication
IbuprofenProduct
Ibuprofen