Clinical trial NCT03918135: Comparison of the Efficacy of Intravenous Paracetamol and Ibuprofen in the Treatment of Fever Due to Upper Respiratory Tract Infection
Official title: Comparison of the Efficacy of Intravenous Paracetamol and Ibuprofen in Patients With Upper Respiratory Tract Infections Presenting With Fever in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fever
Keywords: fever, emergency department, paracetamol, ibuprofen, upper respiratory infection
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Currently, paracetamol, ibuprofen and nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of fever . The objective of the study is compare the efficacy of intravenous ibuprofen and paracetamol in the treatment of patients with upper respiratory tract infections presenting with fever in the emergency department

Detailed description: This is the randomized double blinded clinical trial to compare the efficacy of these two drugs in this clinical setting. A randomized clinical trial was conducted in the Emergency Department (ED) of Pamukkale University Medical Faculty Hospital Study personnel (emergency physicians and emergency service nurses) were trained before the study. When intravenous drugs (Paracetamol and İbuprofen) was being recommended, an eligibility checklist was completed by the attending physician. patients who presented to the emergency department with upper respiratory tract infection and had a temperature above 38.0 ° C were measured by a fever gauge included into the study First Group: 1000 mg of paracetamol ( parol 10mg/ml solution Mefar, Turkey) intravenous (IV) was given 100 patients

Second Group:

Ibuprofen 400 mg ( intrafen 400mg/4ml solution -Gen ilaç san., Turkey) intravenous (IV) was given 100 patients which determined to be applied as a group. Drug packs prepared in 150 ml serum physiology were numbered by an independent nurse, who not involved in the study Randomization was achieved by using computer software to generate random numbers. During the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and rhythms). Patients in both groups received two types of medication in a similarmanner, thus ensuring double blind.

Eligibility criteria: Inclusion Criteria:

* Patients who have fever for less than five days
* At least 1 upper respiratory tract infection (URTI) symptom according URTI questionare

Exclusion Criteria:

* Patients use anti-pyretic last 4 hours
* To be Pregnancy and breast-feeding Patients of childbearing age who are not using a birth control method
* Patients with an allergy trait (paracetamol and Ibuprofen) Illiterates
* Hemodynamically unstable patients
* Patients with renal transplantation
* Patients with glucose 6 phosphate dehydrogenase (G6PD) deficiency
* Patients with non-controlled hypertension
* Patients with a history of cerebrovascular disease
* Patients with severe liver, kidney,pulmonary and cardiac heart failure
* Patients use antibiotics last 7 days
* Patients with Wolff-Parkinson-White syndrome or accompanying arrhythmias associated with conductive stimulus delivery in the heart
* Patients with vision problems

Primary outcomes:
measure: Decreasing of fever
timeFrame: Baseline and 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Atakan Yilmaz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamukkale University
name: Gizem Oncel, MD
role: PRINCIPAL_INVESTIGATOR
References: