Tablet vs. Liquid Suspension Ibuprofen in the Relief of Pain
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time of pain relief
研究概览
简要总结
Ibuprofen (also known as Advil or Motrin) is a medication that is known to reduce pain. It is also known that ibuprofen levels in the blood rise higher and faster if the medication is taken in liquid suspension. This study will attempt to determine if ibuprofen suspended in a liquid works to relieve sore throat pain faster than pills of ibuprofen. It will also determine whether patients with sore throat prefer to take pill or liquid form of the medication.
详细描述
Pain is a common emergency and urgent care complaint. Ibuprofen is known to be an effective treatment for many forms of pain. Sore throat has been established to be an acceptable model of analgesic effect, and ibuprofen has been found to offer relief in studies of sore throat. Several studies have demonstrated that ibuprofen in suspension is absorbed into the system more quickly and results in earlier maximum blood concentrations. To date, no study has evaluated onset to analgesia as reported by the patient for suspension versus tablet formation of ibuprofen in an emergency department population presenting with complaints of sore throat. This is a double blinded randomized placebo controlled trial to compare suspension versus tablet ibuprofen in an emergency department population presenting with sore throat. The purpose of this study is to assess whether ibuprofen in suspension form results in relief of pain more quickly than the tablet form of an equivalent dose of ibuprofen. We will also determine if there is an interval difference from time of analgesia administration to perception of analgesia that is clinically significant.
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, Care Provider)
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 12 years and less than 65 years
- •Weight > 40 kg
- •a provider order for ibuprofen to address pharyngitis pain.
- •Initial Numeric Pain Score > 6
排除标准
- •Known allergy or hypersensitivity to aspirin or NSAIDs
- •Inability to swallow pills
- •Inability to carry out informed consent in English
- •Inability to complete a visual analog pain scale
- •A concomitant order for another class of analgesic
- •Use of analgesic within 8 hours
- •Known 3rd trimester pregnancy
- •Significant medical conditions where participation would pose an unnecessary barrier to ongoing care.
- •Those taking opioid medications for more than 3 days
- •Weight < 40 kg
研究组 & 干预措施
ibuprofen
liquid ibuprofen 400mg compared to tablet ibuprofen 400mg
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Time of pain relief
时间窗: 1 hour
Comparing liquid ibuprofen to tablet ibuprofen to determine which works faster to relieve sore throat pain. We will also determine whether patients with sore throat prefer to take pill or liquid form of medication.
次要结局
未报告次要终点
研究者
Wayne Triner
Professor and Research Director Dept.of Emergency Medicine
Albany Medical College