NCT00484744已完成4 期
Acetaminophen Versus Ibuprofen for the Control of Immediate and Delayed Pain Following Orthodontic Separator Placement
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
- 35
- 试验地点
- 2
- 主要终点
- Pain/discomfort levels reported on Visual Analogue Scales
研究概览
简要总结
The purpose of this research study is to compare pain control effectiveness of two medicines and a placebo (a dummy pill that does not contain any pain relieving medication) to see which one works better at preventing pain when taken both 1 hour before and 6 hours after orthodontic separators are placed. The research hypothesis is that there will be a significant difference in pain as measured by Visual Analogue Scales (VAS) over time and that this effect will differ for acetaminophen versus ibuprofen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 9 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Orthodontic treatment requires banding of posterior teeth
- •Orthodontic treatment requires the placement of two or more separators
- •Able to swallow analgesic pills
- •English speaking
- •Minimum weight requirement of 88 pounds
排除标准
- •Orthodontic appliances are present in the mouth
- •Use of acetaminophen or ibuprofen is contraindicated (allergy, GI problems)
- •Antibiotics or analgesics are currently in use
- •History of systemic disease exists (arthritis, diabetes, cystic fibrosis)
- •Significant cognitive impairment
研究组 & 干预措施
Acetaminophen
Experimental
干预措施: Acetaminophen (Drug)
Ibuprofen
Experimental
干预措施: Ibuprofen (Drug)
Avicel
Placebo Comparator
干预措施: Avicel (placebo) (Drug)
结局指标
主要结局
Pain/discomfort levels reported on Visual Analogue Scales
时间窗: Assessments conducted at six intervals during a 24 hour period
次要结局
未报告次要终点
研究者
研究点 (2)
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