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
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
- 否
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: Paracetamol 1000 mg of paracetamol (parol 10mg/ml solution Mefar,Turkey ) intravenous (IV) was given 102 patients
干预措施: paracetamol (Drug)
dexketoprofen
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
Üzeyir Çimen
Research Assistant
Pamukkale University
