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

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ClinicalTrials.gov Identifier: NCT03768882
Recruitment Status : Completed
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Üzeyir Çimen, Pamukkale University

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

Condition or disease Intervention/treatment Phase
Sore Throat Drug: paracetamol Drug: Dexketoprofen Phase 4

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : July 30, 2018
Actual Study Completion Date : July 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sore Throat

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




Primary Outcome Measures :
  1. Decreament of the pain [ Time Frame: Baseline and 120 minutes ]
    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)


Secondary Outcome Measures :
  1. Symptom frequency [ Time Frame: Baseline and 120 minutes ]
    Detection of upper respiratory tract infections symptoms frequency by using upper respiratory tract infections questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768882


Locations
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Turkey
Pamukkale University
Denizli, Turkey, 20070
Sponsors and Collaborators
Pamukkale University
Investigators
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Principal Investigator: Uzeyir Cimen, MD Pamukkale University

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Responsible Party: Üzeyir Çimen, Research Assistant, Pamukkale University
ClinicalTrials.gov Identifier: NCT03768882     History of Changes
Other Study ID Numbers: 2018TPF012
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Üzeyir Çimen, Pamukkale University:
paracetamol,dexketoprofen,emergency department,sore throat

Additional relevant MeSH terms:
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Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Acetaminophen
Dexketoprofen trometamol
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents