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

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

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

Study Overview

• Status: Completed
• Conditions: Sore Throat
• Intervention / Treatment: Drug: paracetamol; Drug: Dexketoprofen

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Denizli, Turkey, 20070
    • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paracetamol; Experimental: Paracetamol 1000 mg of paracetamol (parol 10mg/ml solution Mefar,Turkey ) intravenous (IV) was given 102 patients	Drug: paracetamol; 1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 102 patients; Other Names: Perfalgan; Paracerol
Experimental: dexketoprofen; Dexketoprofen Second group: dexketoprofen 50 MG (Arveles ampoule -İE Ulagay-Menarini,Turkey) intravenous (IV) was given 98 patients	Drug: Dexketoprofen; Second group: dexketoprofen 50 MG (Arveles ampoule -İE Ulagay -Menarini,Turkey) intravenous (IV) was given 98 patients; Other Names: ASEKET; DARKIN; DEXALGIN; DESTIYO; DEXCORIL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decreament of the pain	Comparison of the change of sore thorat pain VAS (visual analog scale) and Sore throat relief scale score between the two groups. - (First group Paracetamol and Second Dexketoprofen)	Baseline and 120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom frequency	Detection of upper respiratory tract infections symptoms frequency by using upper respiratory tract infections questionnaire	Baseline and 120 minutes

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: Uzeyir Cimen, MD, Pamukkale University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: November 21, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): December 10, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: paracetamol,dexketoprofen,emergency department,sore throat
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pharyngitis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antipyretics; Acetaminophen; Dexketoprofen trometamol
• Other Study ID Numbers: 2018TPF012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No