Paracetamol Impact Study: Prostaglandin Synthesis and Blood Pressure Effects (PIS-PaB)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 主要终点
- Prostanoid levels
研究概览
简要总结
This research program aims to investigate the influence of paracetamol on blood pressure and the cyclooxygenase (COX) - prostaglandine (PG) pathway in patients with pain. Through an observational pilot study, we will use advanced LC/ESI-MS/MS methodology to analyze the COX-OG pathway in plasma and urine. The study will assess the effects of paracetamol compared to ibuprofen, considering different types of pain. The primary focus is to understand the changes in blood pressure and the COX-PG pathway upon initiation or discontinuation of paracetamol, with safety analysis as a secondary consideration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Headache and orosurgical patients treated at the respective charite outpatient clinic.
- •Age 18 years or older
- •Able to consent
- •Patients with migraine type headache treated with paracetamol or ibuprofen within the last 12 hours or not treated with paracetamol or ibuprofen within the last 48 hours
- •Patients treated with with paracetamol or ibuprofen undergoing orosurgery for wisedome tooth extraction
排除标准
- •Pregnancy
- •Arterial hypertension
- •Use of beta blockers
- •Use of COX inhibitors other than paracetamol or ibuprofen, including low-dose acetylsalicylic acid
- •Stable prophylactic therapy of migraine for less than 3 weeks
- •Use of tryptans in the last two days (Frovatriptane in the last 6 days)
- •Oral surgery patients using paracetamol or ibuprofen in the last 24 hours
- •Known allergy to paracetamol or ibuprofen
结局指标
主要结局
Prostanoid levels
时间窗: just before treatment and 24 hours after treatment with paracetamol or ibuprofen
A comprehensive lipidomic analysis measuring the levels of prostanoids in plasma and spot urine samples using liquid chromatography tandem mass spectrometry (LC/ESI-MS/MS) technology in all participants.
次要结局
- Blood pressure(just before treatment and 24 hours after treatment with paracetamol or ibuprofen)
研究者
Engi Algharably
Dr.
Charite University, Berlin, Germany