Potential Benefit of the Combination of Metamizole and Ibuprofen After Third Lower Molar Extraction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- area under the curve for pain in the first 12 postoperative hours
研究概览
简要总结
Postoperative pain is common and particularly outpatients may experience unsatisfactory pain relief. This randomized, double-blind, crossover study of postoperative pain in outpatients undergoing split-mouth, third lower molar extraction aims to examine whether or not the combination of metamizole and ibuprofen is superior to either drug alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •planned sequential both-sided lower third molar extraction (split-mouth) with osteotomy (with or without upper molar extraction in local anesthesia)
- •able to understand the study and the NRS scale
排除标准
- •simultaneous both sided extraction or only upper third molar extraction
- •general anesthesia
- •known or presumed abnormal coagulation status
- •known or presumed liver or renal dysfunction
- •contraindication against metamizole known or suspected (known or suspected allergy against novalgin or other pyrazolones, anaphylactic reaction against NSAIDS, decreased bone marrow function or hematopoesis, hepatic porphyria, glucose-6-phosphate dehydrogenase deficiency, and pregnancy/breastfeeding)
- •contraindication against ibuprofen (known or suspected allergy against ibuprofen, anaphylactic reaction against Nonsteroidal anti-inflammatory drugs (NSAID), active or recurrent stomach or duodenal ulcera or bleeding, severe liver or renal insufficiency, inflammatory bowel syndrome, and pregnancy/breastfeeding)
- •pregnancy and breast feeding mothers
研究组 & 干预措施
Metamizole and Ibuprofen
all patients (n=42) will receive metamizol and ibuprofen in one session. In the other session half will receive metamizol and placebo (n=21) and the other half will receive ibuprofen and placebo. The order will be randomized (balanced).
干预措施: Metamizole and Ibuprofen (Drug)
Metamizole and Placebo
This is one of the two comparators for the Arm "Metamizol and Ibuprofen". n=21
干预措施: Metamizole and Placebo (Drug)
Ibuprofen and Placebo
This is the second of the two comparators for the Arm "Metamizol and Ibuprofen". n=21
干预措施: Ibuprofen and Placebo (Drug)
结局指标
主要结局
area under the curve for pain in the first 12 postoperative hours
时间窗: first 12 postoperative hours
The primary outcome is the area under the curve for pain in the first 12 postoperative hours, as assessed by the numeric rating scale
次要结局
- area under the curve for pain in the first 18 postoperative hours(first 18 postoperative hours)
- night time pain(first night after the intervention)
- highest pain score(total observation period (maximum 18 hours))
- haemorrhage requiring intervention(total observation period (maximum 18 hours))
- need for and timing of rescue medication(total observation period (maximum 18 hours))