NCT03918135

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 17, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

March 9, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

April 15, 2019

Last Update Submit

March 8, 2021

Conditions

Fever

Keywords

fever, emergency department, paracetamol, ibuprofen, upper respiratory infection

Outcome Measures

Primary Outcomes (1)

  • Decreasing of fever

    Comparison of the change of fever between the two groups. - (First group Paracetamol, Second Ibuprofen)

    Baseline and 120 minutes

Study Arms (2)

Paracetamol

EXPERIMENTAL

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

Drug: Paracetamol

İbuprofen

EXPERIMENTAL

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

Drug: Ibuprofen

Interventions

ParacetamolDRUG

1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 100 patients Other Names: * Perfalgan * Paracerol

Paracetamol
IbuprofenDRUG

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

İbuprofen

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have fever for less than five days
  • At least 1 upper respiratory tract infection (URTI) symptom according URTI questionare

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

FeverEmergenciesRespiratory Tract Infections

Interventions

AcetaminophenIbuprofen

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic ProcessesInfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPhenylpropionatesAcids, CarbocyclicCarboxylic Acids

Study Officials

  • Atakan Yilmaz, MD

    Pamukkale University

    PRINCIPAL INVESTIGATOR

  • Gizem Oncel, MD

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research asistant

Study Record Dates

First Submitted

April 15, 2019

First Posted

April 17, 2019

Study Start

January 1, 2019

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

March 9, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)