Analgesic Effect of Ibuprofen 400, 600 and 800 mg, Paracetamol 500 and 1000 mg, and Paracetamol 1000 mg Plus 60 mg Codeine: Single-dose, Randomized, Placebo-controlled and Double-blind Study on Acute Pain After Third Molar Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Sum Pain Intensity Score(SPI)
研究概览
简要总结
The purpose of this placebo controlled clinical trial is to evaluate the dose response relationship of ibuprofen in doses from 400 mg to 800 mg and paracetamol (acetaminophen)in doses from 500 mg to 1000 mg compared with paracetamol (acetaminophen)1000 mg plus codeine 60 mg on acute postoperative pain after surgical removal of impacted third molars.
详细描述
Acetaminophen (paracetamol) and related aspirin-like drugs have traditionally been used for pain control of minor to moderate postoperative pain. Gradually traditional non-steroidal anti-inflammatory drugs (NSAIDs) have become more popular as analgesics due to assumed superior therapeutic effects and aggressive marketing campaigns orchestrated by the pharmaceutical industry.
Ibuprofen is a widely used analgesic both in non-prescription and prescription doses.
A dose-response relationship for low ibuprofen doses is shown. Evidence of a progressing dose response relationship for moderate (i.e. 400 mg) to higher doses is scarce. A possible analgesic ceiling effect has been suggested for doses above 400 mg, although a correlation between given ibuprofen doses above 400 mg and patient serum levels is shown. However, it may be questioned if the plasma concentration of ibuprofen is an important determinator of analgesic drug efficacy. A higher dose is more likely to influence the duration of analgesic effect rather than the peak analgesic effect.
There are few clinical trials investigating the dose-response relationship of increasing ibuprofen doses and paracetamol doses. To our knowledge no published study has investigated the dose-response relationship of ibuprofen and paracetamol in the same trial with a negative (i.e. placebo) and a positive (i.e. best standard analgesic treatment) control group.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both sexes referred for surgical removal of impacted third molars, due to symptoms or after being advised to do so by their dentist.
- •Persons of both sexes (ASA type I).
- •Females who are not pregnant or plan conception.
- •Persons who have not used analgesics for 3 days prior to the day of surgery.
- •Persons without known active ulcus or gastrointestinal bleeding.
- •Persons without any known hypersensitivity for NSAIDs.
- •Persons under no other continuous drug treatment than contraceptives.
- •Caucasian origin.
- •Persons with at least moderate postoperative pain as defined by subjective score on a verbal rating scale after surgical removal of third molars.
排除标准
- •Patients with surgery time exceeding 60 minutes
- •Peroperative complications such as profuse bleeding or perforation to the maxillary sinus requiring additional drug treatment during or after the surgical removal of the third molar.
- •Postoperative complications such as extended bleeding, nausea and regurgitation during the observation period.
- •Smoking before taking the test-drug or during the observation period.
研究组 & 干预措施
Placebo
Single dose placebo capsule
干预措施: Placebo (Drug)
Ibuprofen 400 mg
Single dose ibuprofen 400 mg capsule
干预措施: Ibuprofen 400 mg (Drug)
Ibuprofen 600 mg
Single dose ibuprofen 600 mg capsule
干预措施: Ibuprofen 600 mg (Drug)
Ibuprofen 800 mg
Single dose ibuprofen 800 mg capsule
干预措施: Ibuprofen 800 mg (Drug)
Paracetamol 500 mg
Paracetamol 500 mg (acetaminophen) capsule
干预措施: Paracetamol (acetaminophen) 500 mg (Drug)
Paracetamol 1000 mg
Single dose paracetamol 1000 mg (acetaminophen) capsule
干预措施: Paracetamol (acetaminophen) 1000 mg (Drug)
Paracetamol 1000 mg + codeine 60 mg
Single dose paracetamol (acetaminophen) 1000 mg + codeine 60 mg capsule
干预措施: Paracetamol (acetaminophen) 1000 mg + codeine 60 mg (Drug)
结局指标
主要结局
Sum Pain Intensity Score(SPI)
时间窗: 3 hour observation period
次要结局
- Sum Pain Intensity Difference Score (SPID)(6 hours)
- Sum Pain Intensity Score (SPI)(6 hours)
- Maximum Pain Intensity Difference Score (MAXPID)(Unknown, calculated variable)
- Time to Maximum Pain Intensity Difference Score(Unknown, calculated variable)
- Self-reported Occurrence of Adverse Effects(6 hours)
