Clinical trial NCT03768882: Comparison of the Efficacy of Intravenous Dexketoprofen and Paracetamol in the Treatment of Sore Throat
Official title: Comparison of the Efficacy of Intravenous Dexketoprofen and Paracetamol in the Treatment of Pain in Patients Presenting to the Emergency Department With Sore Throat: A Double-Blinded, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sore Throat
Keywords: paracetamol,dexketoprofen,emergency department,sore throat
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2018-12-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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

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, 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.

Eligibility criteria: 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

Primary outcomes:
measure: Decreament of the pain
timeFrame: Baseline and 120 minutes
Secondary outcomes:
measure: Symptom frequency
timeFrame: Baseline and 120 minutes
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Uzeyir Cimen, MD
role: PRINCIPAL_INVESTIGATOR
References: