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

Primary Purpose

Sore Throat

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
paracetamol
Dexketoprofen
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sore Throat focused on measuring paracetamol,dexketoprofen,emergency department,sore throat

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pamukkale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Paracetamol

dexketoprofen

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Symptom frequency
Detection of upper respiratory tract infections symptoms frequency by using upper respiratory tract infections questionnaire

Full Information

First Posted
November 21, 2018
Last Updated
December 6, 2018
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT03768882
Brief Title
Comparison of the Efficacy of Intravenous Dexketoprofen and Paracetamol in the Treatment of Sore Throat
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
July 30, 2018 (Actual)
Study Completion Date
July 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sore Throat
Keywords
paracetamol,dexketoprofen,emergency department,sore throat

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paracetamol
Arm Type
Experimental
Arm Description
Experimental: Paracetamol 1000 mg of paracetamol (parol 10mg/ml solution Mefar,Turkey ) intravenous (IV) was given 102 patients
Arm Title
dexketoprofen
Arm Type
Experimental
Arm Description
Dexketoprofen Second group: dexketoprofen 50 MG (Arveles ampoule -İE Ulagay-Menarini,Turkey) intravenous (IV) was given 98 patients
Intervention Type
Drug
Intervention Name(s)
paracetamol
Other Intervention Name(s)
Perfalgan, Paracerol
Intervention Description
1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 102 patients
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen
Other Intervention Name(s)
ASEKET, DARKIN, DEXALGIN, DESTIYO, DEXCORIL
Intervention Description
Second group: dexketoprofen 50 MG (Arveles ampoule -İE Ulagay -Menarini,Turkey) intravenous (IV) was given 98 patients
Primary Outcome Measure Information:
Title
Decreament of the pain
Description
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)
Time Frame
Baseline and 120 minutes
Secondary Outcome Measure Information:
Title
Symptom frequency
Description
Detection of upper respiratory tract infections symptoms frequency by using upper respiratory tract infections questionnaire
Time Frame
Baseline and 120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uzeyir Cimen, MD
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
ZIP/Postal Code
20070
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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