Effects of Pre-emptive Use of Combined Ibuprofen and Acetaminophen on Pain Control in Orthodontic Treatment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment
研究概览
简要总结
This study is designed to determine if the preemptive use of a combination of acetaminophen and ibuprofen is more effective in reducing pain following orthodontic tooth movement when compared to the use of acetaminophen and ibuprofen alone.
详细描述
This study is designed to determine if the preemptive use of a combination of acetaminophen and ibuprofen is more effective in reducing pain following orthodontic tooth movement when compared to the use of acetaminophen and ibuprofen alone. Before their orthodontic appointment, participants will be administered acetaminophen (650mg), ibuprofen (400mg), or acetaminophen (650mg) + ibuprofen (400mg). Participants will be asked to record their pain intensity using a numerical (0-10) visual analog scale (VAS) during rest, light biting, and while chewing paraffin wax during the following time intervals: immediately following drug administration, 6 hours after, the morning after, and the second morning after orthodontic treatment.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The medications were prepared by the Kelley-Ross Compounding Group (Seattle, WA) and were identical in appearance. The bottles were labeled as "A", "B", or "C" and the identity of the medications were not revealed until after the data analysis was completed.
入排标准
- 年龄范围
- 12 Years 至 59 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Orthodontic patient presenting for orthodontic treatment
排除标准
- •History of taking an analgesic in the past six hours
- •Hypersensitivity to ibuprofen or acetaminophen
- •Aspirin-sensitive asthma
- •Renal or liver impairment
- •History of GI bleeding or ulcers
- •Cardiovascular disease, recent myocardial infarction, heart failure, or coronary artery bypass graft surgery
- •Currently taking antibiotics or other medications for a chronic systemic disease
- •Bleeding disorder
- •Pregnant or nursing
研究组 & 干预措施
Acetaminophen
Acetaminophen 650mg powder in gel capsule taken by mouth before entering appointment
干预措施: Acetaminophen (Drug)
Ibuprofen
Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment
干预措施: Ibuprofen (Drug)
Acetaminophen and Ibuprofen
Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment
干预措施: Acetaminophen (Drug)
Acetaminophen and Ibuprofen
Acetaminophen 650mg and Ibuprofen 400mg powder in gel capsule taken by mouth before entering appointment
干预措施: Ibuprofen (Drug)
结局指标
主要结局
Visual Analog Scale (VAS) Pain Scores at 6 Hours After Treatment
时间窗: 6 hours after orthodontic treatment
Pain scores were measured and recorded by selecting a number \[0-10\] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax. The VAS consisted of a 10cm numerical scale from 0, representing "no pain," to 10, representing "worst possible, unbearable, excruciating pain."
Visual Analog Scale (VAS) Pain Scores at 1 Day After Treatment
时间窗: 1 day after orthodontic treatment
Pain scores were measured and recorded by selecting a number \[0-10\] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax. The VAS consisted of a 10cm numerical scale from 0, representing "no pain," to 10, representing "worst possible, unbearable, excruciating pain."
Visual Analog Scale (VAS) Pain Scores at 2 Days After Treatment
时间窗: 2 days after orthodontic treatment
Pain scores were measured and recorded by selecting a number \[0-10\] using a visual analog scale to assess pain during the following actions: jaw at rest, lightly biting, and chewing paraffin wax. The VAS consisted of a 10cm numerical scale from 0, representing "no pain," to 10, representing "worst possible, unbearable, excruciating pain."
次要结局
未报告次要终点
研究者
Andrew Keith
Principal Investigator
University of Washington