Comparison of the Efficacy of Intravenous Paracetamol and Ibuprofen in the Treatment of Fever Due to Upper Respiratory Tract Infection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of the Efficacy of Intravenous Paracetamol and Ibuprofen in Patients With Upper Respiratory Tract Infections Presenting With Fever in the Emergency Department

Conditions
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Fever

Intervention / Treatment
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* Drug: Paracetamol
* Drug: Ibuprofen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paracetamol<br>Paracetamol 1000 mg of paracetamol (parol 10mg/ml solution Mefar,Turkey ) intravenous (IV) was given 100 patients | Drug: Paracetamol<br>* 1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 100 patients Other Names: Perfalgan Paracerol<br>|
| Experimental: İbuprofen<br>İbuprofen 400mg of ibuprofen (intrafen 400mg/4ml solution Gen ilaç sanayi,Turkey ) intravenous (IV) was given 100 patients | Drug: Ibuprofen<br>* 400mg of ibuprofen(intrafen 400mg/4ml Gen ilaç sanayi, Turkey) intravenous (IV) was given 100 patients Other Names: Dorifen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreasing of fever | Comparison of the change of fever between the two groups. - (First group Paracetamol, Second Ibuprofen) | Baseline and 120 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fever, emergency department, paracetamol, ibuprofen, upper respiratory infection