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

Fever Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03918135
• Other study ID #: 2019TIPF002
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: January 1, 2020

Study information

• Verified date: March 2021
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: January 1, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Infection
• Respiratory Tract Infections

Intervention

Drug:
• Paracetamol
1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 100 patients Other Names: Perfalgan Paracerol
• Ibuprofen
400mg of ibuprofen(intrafen 400mg/4ml Gen ilaç sanayi, Turkey) intravenous (IV) was given 100 patients Other Names: Dorifen

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreasing of fever	Comparison of the change of fever between the two groups. - (First group Paracetamol, Second Ibuprofen)	Baseline and 120 minutes