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

NCT ID: NCT03918135

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2020-01-01

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.

Conditions

Fever

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Paracetamol

Paracetamol 1000 mg of paracetamol (parol 10mg/ml solution Mefar,Turkey ) intravenous (IV) was given 100 patients

Group Type: EXPERIMENTAL

Paracetamol

Intervention Type: DRUG

1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 100 patients

Other Names:

• Perfalgan
• Paracerol

İbuprofen

İbuprofen 400mg of ibuprofen (intrafen 400mg/4ml solution Gen ilaç sanayi,Turkey ) intravenous (IV) was given 100 patients

Group Type: EXPERIMENTAL

Ibuprofen

Intervention Type: DRUG

400mg of ibuprofen(intrafen 400mg/4ml Gen ilaç sanayi, Turkey) intravenous (IV) was given 100 patients

Other Names:

Dorifen

Interventions

Paracetamol

1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 100 patients

Other Names:

• Perfalgan
• Paracerol

Intervention Type: DRUG

Ibuprofen

400mg of ibuprofen(intrafen 400mg/4ml Gen ilaç sanayi, Turkey) intravenous (IV) was given 100 patients

Other Names:

Dorifen

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Üzeyir Çimen

Research asistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atakan Yilmaz, MD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Gizem Oncel, MD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

Pamukkale University

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2019TIPF002

Identifier Type: -

Identifier Source: org_study_id