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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03768882
Enrollment
200
Registered
2018-12-07
Start date
2017-12-01
Completion date
2018-07-30
Last updated
2018-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sore Throat

Keywords

paracetamol,dexketoprofen,emergency department,sore throat

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.

Interventions

DRUGparacetamol

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

DRUGDexketoprofen

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

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Decreament of the painBaseline and 120 minutesComparison 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

MeasureTime frameDescription
Symptom frequencyBaseline and 120 minutesDetection of upper respiratory tract infections symptoms frequency by using upper respiratory tract infections questionnaire

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026