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临床试验/NCT03768882
NCT03768882已完成4 期

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

Pamukkale University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年12月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
200
试验地点
1
主要终点
Decreament of the pain

研究概览

简要总结

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

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

研究组 & 干预措施

Paracetamol

Experimental

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

干预措施: paracetamol (Drug)

dexketoprofen

Experimental

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

干预措施: Dexketoprofen (Drug)

结局指标

主要结局

Decreament of the pain

时间窗: 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)

次要结局

  • Symptom frequency(Baseline and 120 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Üzeyir Çimen

Research Assistant

Pamukkale University

研究点 (1)

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