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

ClinicalTrials.gov ID NCT03768882
Sponsor Pamukkale University
Information provided by Üzeyir Çimen, Pamukkale University (Responsible Party)
Last Update Posted 2018-12-10
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Study Overview

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.

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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
Conditions
Sore Throat
Intervention / Treatment
  • Drug: paracetamol
  • Drug: Dexketoprofen
  • Drug: paracetamol
  • Drug: Dexketoprofen
Other Study ID Numbers
  • 2018TPF012
Study Start (Actual)
2017-12-01
Primary Completion (Actual)
2018-07-30
Study Completion (Actual)
2018-07-30
Enrollment (Actual)
200
Study Type
Interventional
Phase
Phase 4

Contacts and Locations

This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.

To learn more, please see the Contacts and Locations section in How to Read a Study Record(https://clinicaltrials.gov/study-basics/how-to-read-study-record#contacts-and-locations).

This study has 1 location
Turkey
Denizli, Turkey, 20070

Pamukkale University
Click to view interactive map

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies(https://clinicaltrials.gov/study-basics/learn-about-studies).
Eligibility Criteria
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
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Ages Eligible for Study
18 Years and older (AdultOlder Adult )
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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Design Details
Primary Purpose : Treatment
Allocation : Randomized
Interventional Model : Factorial Assignment
Masking : Triple (ParticipantCare ProviderInvestigator)

Arms and Interventions

Participant Group/Arm Intervention/Treatment
Participant Group/Arm Experimental: Paracetamol
Experimental: Paracetamol 1000 mg of paracetamol (parol 10mg/ml solution Mefar,Turkey ) intravenous (IV) was given 102 patients
Intervention/Treatment Drug: paracetamol
  • 1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 102 patients

  • Other Names:
    • Perfalgan
    • Paracerol
Participant Group/Arm Experimental: dexketoprofen
Dexketoprofen Second group: dexketoprofen 50 MG (Arveles ampoule -İE Ulagay-Menarini,Turkey) intravenous (IV) was given 98 patients
Intervention/Treatment 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
Primary Outcome Measures
Outcome Measure Measure Description Time Frame
Decreament of the painComparison 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 frequencyDetection of upper respiratory tract infections symptoms frequency by using upper respiratory tract infections questionnaireBaseline and 120 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.
Sponsor
Pamukkale University
Investigators
  • Principal Investigator:Uzeyir Cimen, MD,Pamukkale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
2018-11-21
First Submitted that Met QC Criteria
2018-12-06
First Posted
2018-12-07
Study Record Updates
Last Update Submitted that met QC Criteria
2018-12-06
Last Update Posted
2018-12-10
Last Verified
2018-12

More Information

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Keywords Provided by Üzeyir Çimen, Pamukkale University
Additional Relevant MeSH Terms

Plan to Share Individual Participant Data (IPD)?
No