Comparison of Two Combinations of Opioid and Non-opioid Analgesics for Acute Periradicular Abscess: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 主要终点
- Reduction of pain scores over time.
研究概览
简要总结
Aim: The aim of this study was to compare the analgesic efficacy of two combinations of opioid and non-opioid analgesics for acute periradicular abscesses.
Methodology: This study included 24 patients who sought emergency care in a Brazilian dental school. The patients were randomly divided into two groups: Codeine/Acetaminophen - oral prescription of codeine (30 mg) plus acetaminophen (500 mg), every 4 h, for 3 days or Tramadol/Acetaminophen - oral prescription of tramadol hydrochloride (37.5 mg) plus acetaminophen (500 mg) on the same schedule. Patients recorded pain scores in a pain diary 6, 12, 24, 48, and 72 h after treatment, using the Visual Analogue Scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- •Clinical diagnosis of Acute Periradicular Abscess
- •Age greater than 18 years
- •Spontaneous pain greater than 40 mm measured in Visual Analogue Scale (moderate to severe pain).
排除标准
- •Intake of analgesics or antibiotics within 4 hours prior to emergency surgery
- •Allergy to the drugs used in this study
- •Gastric ulcer, liver or kidney disease
- •Uncontrolled diabetes mellitus or epilepsy
- •Pregnancy or lactation
研究组 & 干预措施
Co/ Ac
Codeine/acetaminophen (30 mg/500 mg) analgesic association tablets. Patients in this group received one fixed-dose oral tablet of codeine/acetaminophen (30 mg/500 mg) every 4 hours for 3 days.
干预措施: Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days (Drug)
Tr/ Ac
Tramadol/acetaminophen (37.5 mg/325 mg) analgesic association tablets. Patients in this group received one fixed-dose oral tablet of tramadol/acetaminophen (37.5 mg/325 mg) every 4 hours for 3 days.
干预措施: Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days (Drug)
结局指标
主要结局
Reduction of pain scores over time.
时间窗: 0, 6, 12, 24, 48 and 72 h after first dose administration
Pain scores were obtained using VAS before and after the first appointment.
次要结局
- Frequency of additional medication(Up to 72 hours)
- Adverse reactions reported by patients(Up to 72 hours)
研究者
Manuela Favarin Santin
PhD
Federal University of Rio Grande do Sul