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

March 8, 2021 updated by: Üzeyir Çimen, Pamukkale University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Denizli, Turkey, 20070
        • Pamukkale University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paracetamol
Paracetamol 1000 mg of paracetamol (parol 10mg/ml solution Mefar,Turkey ) intravenous (IV) was given 100 patients
Drug: Paracetamol

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

Other Names:

  • Perfalgan
  • Paracerol
Experimental: İbuprofen
İbuprofen 400mg of ibuprofen (intrafen 400mg/4ml solution Gen ilaç sanayi,Turkey ) intravenous (IV) was given 100 patients
Drug: Ibuprofen

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

Other Names:

Dorifen

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Investigators

  • Principal Investigator: Gizem Oncel, MD, Pamukkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

April 15, 2019

First Posted (Actual)

April 17, 2019

Study Record Updates

Last Update Posted (Actual)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 8, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019TIPF002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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