NCT02439034已完成2 期
Paracetamol With or Without Ketoprofen in the Management of Pain During Hospitalisation and at Home for Patients Receiving Brachytherapy: Phase-2 Randomized Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Level of immediate post-operative pain
研究概览
简要总结
The results of the study will permit to set up a standardized and validated procedure of pain management authorizing medical and paramedical staff of brachytherapy department to handle pain and in this way to improve the quality of life of the patients.
详细描述
- Selection criteria validation
- Patient information and collection of a signed informed consent
- Randomization
- Completion of HADS questionnaire
- Day 1 = Begin of analgesic treatment / brachytherapy
- T-30= 30 minutes before the operative procedure, IV administration of the analgesic treatment (Arm A or B) by the anesthetist
- T0= end of the operative procedure under general anesthesia
- T4, T8, and T12 = 4, 8 and 12 hours after T0: evaluation of pain level. If pain level ≥ 4:
- paracetamol-codeine (Arms A and B) and continuation of ketoprofen (Arm B). Then, if persistence of pain :
- paracetamol and morphine (Arms A and B)
- Day 2 to Day 30: At home or during hospital stay:
Pain assessment twice a day by the patient until absence of pain during 2 consecutive days
- Day 3 and Day 15: Pain assessment or phone interview by the algologist of the investigation center ; completion of a HADS questionnaire on Day 3
- Day 30= End of study: Pain assessment by the algologist of the investigation center and HADS questionnaire
In any case, pain assessment must be done until absence of pain during 2 consecutive days
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with a uterine cervical cancer or an upper aero-digestive tract cancer
- •Age ≥ 18 years and ≤ 75 years
- •Patient who are eligible for brachytherapy treatment associated with or without hospital stay
- •With operative procedure under general anesthesia to set up the material needed for brachytherapy
- •Performance status ≤ 2
- •Creatinine Clearance ≥ 60 ml/min using Cockcroft equation
- •No coagulation disorder or anticoagulation therapy at curative dose
- •Registered with a social security system
- •Patient having dated and signed an informed consent form before initiation of any study procedures
排除标准
- •Respiratory pathology (SpO2< 70 %)
- •Severe undernutrition
- •Previous hypersensitivity reactions such as bronchospasm, asthma, rhinitis, hives or other allergic reaction to ketoprofen, to acetylsalicylic acid, or other NSAIDs
- •Previous hemorrhage or gastrointestinal perforation during a previous treatment with NSAID
- •Gastrointestinal hemorrhage , cerebrovascular hemorrhage or other evolutive hemorrhage
- •Evolutive peptic ulcer, previous peptic ulcer or recurring hemorrhage (2 or more distinct episodes of hemorrhage or ulcer objectified)
- •Liver insufficiency
- •Severe renal insufficiency
- •Severe heart failure
- •Treatment with another NSAID, including selective cyclooxygenase-2 inhibitors
- •Intolerance or hypersensitivity to one of the treatments or excipients
- •Inability to swallow
- •Pregnant or breastfeeding woman
- •Patient under tutorship or guardianship
研究组 & 干预措施
Arm A
Active Comparator
Paracetamol
干预措施: Paracetamol (Drug)
Arm B
Experimental
Paracetamol + Ketoprofen
干预措施: Paracetamol (Drug)
Arm B
Experimental
Paracetamol + Ketoprofen
干预措施: Ketoprofen (Drug)
结局指标
主要结局
Level of immediate post-operative pain
时间窗: Day 1
Immediate post-operative pain will be assessed on a scale from 0 to 10. Experimental treatment will be considered as a success if the level of pain is \< 4, 4 hours after the surgical operation.
次要结局
- Assessment of anxiety(inclusion, Days 3 and 30)
- Level of pain linked to the operative procedure during brachytherapy and at home(Day 1 (8, 12 hours), Days 3, 15 and 30)
- Tolerance of the analgesic treatment(30 days)
研究者
研究点 (1)
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