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

Pamukkale University

Status and phase

Completed

Phase 4

Conditions

Sore Throat

Treatments

Drug: paracetamol

Drug: Dexketoprofen

Study type

Interventional

Funder types

Other

Identifiers

NCT03768882

2018TPF012

Details and patient eligibility

About

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

Full 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.

Enrollment

200 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 URTI questionare,
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 criteria

Patients use analgesic last 12 hours
Patients with severe liver, kidney,pulmonary and cardiac heart failure
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 dexketoprofen) Illiterates
Patients with vision problems
Patients use antibiotics last 24 hours
Patients use kinolons last 7 days
Patienst use lozange,throat spray or menthol containing products last 4 hours
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 Wolff-Parkinson-White syndrome or accompanying arrhythmias associated with conductive stimulus delivery in the heart