NCT05239767已完成4 期
A Randomized Trial of NSAID Dosing Strategies
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
- 407
- 试验地点
- 1
- 主要终点
- Failure to achieve a minimum clinically important difference
研究概览
简要总结
This study will compare the efficacy of two different non-steroidal anti-inflammatory drugs (NSAIDs) ketorolac and ibuprofen for people with acute moderate or severe musculoskeletal pain. The investigators will also determine whether taking acetaminophen prior to the NSAID impacts efficacy
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
NSAID will be masked. Acetaminophen or no acetaminophen will not
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute musculoskeletal pain: Any pain attributable to muscles, bones, joints, tendons, ligaments or supporting structures, as determined by the clinical team, of 10 days duration or less. Prior to the onset of acute pain, patients cannot have experienced pain in the same body region during the prior six months
- •Pain has to be described as moderate or severe, when the patient is asked if the pain is mild, moderate or severe in intensity
排除标准
- •Contraindication to NSAIDs (allergy to NSAID or allergy to aspirin without history of tolerating NSAIDs, history of gastrointestinal bleeding, daily medication for gastritis or PUD, chronic kidney disease 2-5, heart failure)
- •Contraindication to acetaminophen (hepatitis or cirrhosis)
- •Use of an NSAID within the previous eight hours
- •Use of acetaminophen within the previous eight hours
- •Chronic pain, defined as any pain on >50% of days for at least 3 months prior to onset of acute pain
- •Recurrent pain in the same body part as the presenting complaint
研究组 & 干预措施
Ibuprofen
Active Comparator
Ibuprofen 800mg orally x 1
干预措施: NSAID (Drug)
Ketorolac
Active Comparator
Ketorolac 20mg orally x 1
干预措施: NSAID (Drug)
结局指标
主要结局
Failure to achieve a minimum clinically important difference
时间窗: Two hours
Failure to improve by at least 1.3 points on a 0-10 pain scale
次要结局
- Epigastric pain(Two hours after medication administration)
- 0-10 pain score(One and two hours after medication administration)
- Ordinal pain scale(One and two hours after medication administration)
研究者
研究点 (1)
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