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

NCT03768882 | Completed Phase 4 DMC

• 1 other identifier: 2018TPF012
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

Sore Throat

Keywords

paracetamol,dexketoprofen,emergency department,sore throat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Symptom frequency

  Baseline and 120 minutes

Study Arms (2)

Paracetamol

EXPERIMENTAL

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

Drug: paracetamol

dexketoprofen

EXPERIMENTAL

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

Drug: Dexketoprofen

Interventions

paracetamol DRUG

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

Also known as: Perfalgan, Paracerol

Paracetamol

Dexketoprofen DRUG

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

Also known as: ASEKET, DARKIN, DEXALGIN, DESTIYO, DEXCORIL

dexketoprofen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),
• mm or more according to the sore throat sensitivity scale (STSS),
• mm and above according to difficulty swallowing scale (DSS),
• mm and above according to the swollen throat scale (SwoTS)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pharyngitis

Interventions

Acetaminophen; dexketoprofen trometamol

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Uzeyir Cimen, MD

  Pamukkale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: November 21, 2018
• First Posted: December 7, 2018
• Study Start: December 1, 2017
• Primary Completion: July 30, 2018
• Study Completion: July 30, 2018
• Last Updated: December 10, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)