2024-518795-31-00招募中3 期
Pilot study of the pharmacokinetic profile of paracetamol subcutaneously versus intravenously in patients in a palliative situation
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- - Measurement of paracetamolemia to determine AUC0-t, AUC0-, Cmax , Vd and t1/2 for each mode of administration for the same patient, and generation of pharmacokinetic curves.
研究概览
简要总结
Determine the pharmacokinetic profile of subcutaneous Paracetamol in palliative care patients and compare it to the intravenous pharmacokinetic profile in the same patients
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patient (18 years or older) with a pathology under palliative care (defined by the WHO as active, comprehensive care given to patients whose condition does not respond to curative treatment)- Hospitalized patient (18 years or older) with a pathology under palliative care (defined by the WHO as active, comprehensive care given to patients whose condition does not respond to curative treatment).
- •The need to be affiliated to the social security system
- •With a functional central IV line with reflux (implantable venous site, picc-line, central line)
- •Presenting spontaneous pain, not related to care, with a numerical scale (EN) greater than 3/10 or having a prescription for paracetamol as part of their usual treatment
- •Patient able to self-assess pain with an EN
- •No contraindication to paracetamol
- •No contraindication to the administration of alternative analgesics (weak opioids, strong opioids, NSAIDs) during the protocol and washout periods.
- •No medical contraindication to the suspension of Paracetamol in the 24 hours preceding the first study administration (e.g. absence of fever).
- •Have a blood test less than 7 days old, showing no end-stage liver or kidney disease contraindicating paracetamol administration
- •Patient agreement to take part in study, informed consent signature collected
排除标准
- •Patient under 18 years of age
- •Patient having received a Weak opioid (immediate-release tramadol) within 2 hours or a Strong opioid (immediate-release morphine or oxycodone, injectable or oral, injectable or transmucosal fentanyl) within one hour prior to administration of paracetamol (as part of tolerance monitoring).
- •Patient with fever
- •No functional venous line
- •No communication possible
- •Patient under legal protection
- •Patient participating in another research protocol or having participated in another protocol within less than 30 days
- •Patients with contraindications to paracetamol
- •Weights under 50 kg
- •Patient is not palliative (as defined by the WHO) for his disease
- •Patients with contraindications to subcutaneous treatment (infection or edema at puncture site)
- •Pregnant or breast-feeding women
- •Patient having received paracetamol within 24 hours prior to the first paracetamol administration in the study
结局指标
主要结局
- Measurement of paracetamolemia to determine AUC0-t, AUC0-, Cmax , Vd and t1/2 for each mode of administration for the same patient, and generation of pharmacokinetic curves.
- Measurement of paracetamolemia to determine AUC0-t, AUC0-, Cmax , Vd and t1/2 for each mode of administration for the same patient, and generation of pharmacokinetic curves.
次要结局
- - Pain assessment using a digital scale
- - Skin monitoring and tolerance assessment throughout administration and protocol completion (D0 to D30)
- - Safety criterion: systematic collection of adverse events of any grade (CTCAE scale) from the signing of consent to D30 (minimum follow-up period for drug research).
研究者
Investigateur Coordinateur
Scientific
Centre Hospitalier Universitaire De Caen Normandie
研究点 (1)
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