Comparison of the Efficacy of Intravenous Paracetamol and Ibuprofen in the Treatment of Fever Due to Upper Respiratory Tract Infection
Primary Purpose
Fever
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Paracetamol
Ibuprofen
Sponsored by
About this trial
This is an interventional treatment trial for Fever focused on measuring fever, emergency department, paracetamol, ibuprofen, upper respiratory infection
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
Sites / Locations
- Pamukkale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Paracetamol
İbuprofen
Arm Description
Paracetamol 1000 mg of paracetamol (parol 10mg/ml solution Mefar,Turkey ) intravenous (IV) was given 100 patients
İbuprofen 400mg of ibuprofen (intrafen 400mg/4ml solution Gen ilaç sanayi,Turkey ) intravenous (IV) was given 100 patients
Outcomes
Primary Outcome Measures
Decreasing of fever
Comparison of the change of fever between the two groups. - (First group Paracetamol, Second Ibuprofen)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03918135
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever
Keywords
fever, emergency department, paracetamol, ibuprofen, upper respiratory infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paracetamol
Arm Type
Experimental
Arm Description
Paracetamol 1000 mg of paracetamol (parol 10mg/ml solution Mefar,Turkey ) intravenous (IV) was given 100 patients
Arm Title
İbuprofen
Arm Type
Experimental
Arm Description
İbuprofen 400mg of ibuprofen (intrafen 400mg/4ml solution Gen ilaç sanayi,Turkey ) intravenous (IV) was given 100 patients
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 100 patients
Other Names:
Perfalgan
Paracerol
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
400mg of ibuprofen(intrafen 400mg/4ml Gen ilaç sanayi, Turkey) intravenous (IV) was given 100 patients
Other Names:
Dorifen
Primary Outcome Measure Information:
Title
Decreasing of fever
Description
Comparison of the change of fever between the two groups. - (First group Paracetamol, Second Ibuprofen)
Time Frame
Baseline and 120 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atakan Yilmaz, MD
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gizem Oncel, MD
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of the Efficacy of Intravenous Paracetamol and Ibuprofen in the Treatment of Fever Due to Upper Respiratory Tract Infection
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