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

NCT ID: NCT03768882

Last Updated: 2018-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-07-30

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.

Conditions

Sore Throat

Keywords

paracetamol,dexketoprofen,emergency department,sore throat

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Paracetamol

Experimental: Paracetamol 1000 mg of paracetamol (parol 10mg/ml solution Mefar,Turkey ) intravenous (IV) was given 102 patients

Group Type: EXPERIMENTAL

paracetamol

Intervention Type: DRUG

1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 102 patients

dexketoprofen

Dexketoprofen Second group: dexketoprofen 50 MG (Arveles ampoule -İE Ulagay-Menarini,Turkey) intravenous (IV) was given 98 patients

Group Type: EXPERIMENTAL

Dexketoprofen

Intervention Type: DRUG

Second group: dexketoprofen 50 MG (Arveles ampoule -İE Ulagay -Menarini,Turkey) intravenous (IV) was given 98 patients

Interventions

paracetamol

1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 102 patients

Intervention Type: DRUG

Dexketoprofen

Second group: dexketoprofen 50 MG (Arveles ampoule -İE Ulagay -Menarini,Turkey) intravenous (IV) was given 98 patients

Intervention Type: DRUG

Other Intervention Names

Perfalgan; Paracerol; ASEKET; DARKIN; DEXALGIN; DESTIYO; DEXCORIL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Üzeyir Çimen

Research Assistant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Uzeyir Cimen, MD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

Pamukkale University

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2018TPF012

Identifier Type: -

Identifier Source: org_study_id