Comparison of the Efficacy of Intravenous Dexketoprofen and Paracetamol in the Treatment of Sore Throat

Last updated: December 6, 2018
Sponsor: Pamukkale University
Overall Status: Completed

Phase

4

Condition

Pharyngitis

Treatment

N/A

Clinical Study ID

NCT03768882
2018TPF012
  • Ages > 18
  • All Genders

Study Summary

Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of sore throat. The objective of the study is compare the efficacy of intravenous dexketoprofen and paracetamol in the treatment of the pain in patients presenting to the emergency department with sore throat

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients with sore throat less than three days, Patients with at least one of the following

  • According to the throat pain scale, patients with moderate-severe pain,

  • At least 1 upper respiratory tract infection (URTI) symptom according URTIquestionare,

  • Objective findings of pharyngeal inflammation (Tonsillopharyngitis evaluation score ≥5),

  • 60 mm or more according to the sore throat sensitivity scale (STSS),

  • 50 mm and above according to difficulty swallowing scale (DSS),

  • 33 mm and above according to the swollen throat scale (SwoTS)

Exclusion

Exclusion Criteria: Patients use analgesic last 12 hours, Patients with severe liver, kidney,pulmonary andcardiac heartfailure To be Pregnancy and breast-feeding Patients of childbearing age whoare not using a birth control method, , Patients with an allergy trait (paracetamol anddexketoprofen) Illiterates,Patients with vision problems,Patients use antibiotics last 24hours, Patients use kinolons last 7 days,Patienst use lozange,throat spray or mentholcontaining products last 4 hours,Hemodynamically unstable patients,Patients with renaltransplantation, Patients with glucose 6 phosphate dehydrogenase (G6PD) deficiency,Patients with non-controlled hypertension, Patients with a history of cerebrovasculardisease,Patients with Wolff-Parkinson-White syndrome or accompanying arrhythmias associatedwith conductive stimulus delivery in the heart,

Study Design

Total Participants: 200
Study Start date:
December 01, 2017
Estimated Completion Date:
July 30, 2018

Study 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, Dexketoprofen) was being recommended, an eligibility checklist was completed by the attending physician. Sore throat pain intensity scale was used to measure the severity of sore throat. According to the throat pain scale, patients with moderate-severe pain, at least 1 upper respiratory tract infection (URTI) symptom according URTI questionare, with objective findings of pharyngeal inflammation (Tonsillopharyngitis evaluation score ≥5), 60 mm or more according to the sore throat sensitivity scale (STSS), 50 mm and above according to difficulty swallowing scale (DSS), 33 mm and above according to the swollen throat scale (SwoTS) were included in the study and evaluated according to these scales.

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

dexketoprofen 50 mg ( arveles ampoule -IE Ulagay-Menarini, 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.

Connect with a study center

  • Pamukkale University

    Denizli, 20070
    Turkey

    Site Not Available

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