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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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ClinicalTrials.gov Identifier: NCT03918135
Recruitment Status : Recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Üzeyir Çimen, Pamukkale University

Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date April 17, 2019
Actual Study Start Date  ICMJE January 1, 2019
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
Decreasing of fever [ Time Frame: Baseline and 120 minutes ]
Comparison of the change of fever between the two groups. - (First group Paracetamol, Second Ibuprofen)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Efficacy of Intravenous Paracetamol and Ibuprofen in the Treatment of Fever Due to Upper Respiratory Tract Infection
Official Title  ICMJE Comparison of the Efficacy of Intravenous Paracetamol and Ibuprofen in Patients With Upper Respiratory Tract Infections Presenting With Fever in the Emergency Department
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Fever
Intervention  ICMJE
  • Drug: Paracetamol

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

    Other Names:

    • Perfalgan
    • Paracerol
  • Drug: Ibuprofen

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

    Other Names:

    Dorifen

Study Arms  ICMJE
  • Experimental: Paracetamol
    Paracetamol 1000 mg of paracetamol (parol 10mg/ml solution Mefar,Turkey ) intravenous (IV) was given 100 patients
    Intervention: Drug: Paracetamol
  • Experimental: İbuprofen
    İbuprofen 400mg of ibuprofen (intrafen 400mg/4ml solution Gen ilaç sanayi,Turkey ) intravenous (IV) was given 100 patients
    Intervention: Drug: Ibuprofen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 15, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2020
Estimated Primary Completion Date January 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Uzeyir Cimen, MD +905432219563 uzeyircmn@gmail.com
Contact: Gizem Oncel, MD +905059735143 gizemoncel@gmail.com
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03918135
Other Study ID Numbers  ICMJE 2019TIPF002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Üzeyir Çimen, Pamukkale University
Study Sponsor  ICMJE Pamukkale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Atakan Yilmaz, MD Pamukkale University
Principal Investigator: Gizem Oncel, MD Pamukkale University
PRS Account Pamukkale University
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP