NCT00524927已完成4 期
A Phase IV, Randomized, Double Blind, Single Centre, Placebo Controlled Study to Assess the Safety and Efficacy of Methoxyflurane [Penthrox] for the Treatment of Incident Pain in Participants Undergoing a Bone Marrow Biopsy Procedure
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Determine where there is a difference in efficacy between Methoxyflurane and placebo for control of pain in participants undergoing a Bone Marrow Biopsy
研究概览
简要总结
This study aims to provide further supportive evidence that Methoxyflurane, a potent analgesic, administered using the Penthrox Inhaler is safe and efficacious in adult participants, specifically those who experience incident pain associated with a planned bone marrow biopsy.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult participants (18 years of age or older)
- •Able to give written informed consent
- •Anticipated episode(s) of incident pain related to planned BMB lasting no more than 30 minutes on average
- •Anticipated life expectancy of at least 1 month
排除标准
- •Subjects with a clinical condition that may, in the opinion of the investigator, impact on the subject's ability to participate in the study, or on the study results
- •Participants who have had IV sedation/opioid on previous BMB and who wish to receive IV sedation/opioid on this occasion or who in the opinion of the BMB operator would be advised to receive IV sedation/opioid on this occasion
- •Concomitant use of other investigational agents
- •Concomitant use of nephrotoxic agents such as gentamicin
- •Uncontrolled INR (>4)
- •Personal or familial hypersensitivity to fluorinated anaesthetics
- •Personal or familial malignant hyperthermia
- •Respiratory rate of less than 10 per minute
- •Has previously received methoxyflurane
- •Known pre-existing renal or hepatic impairment
- •Compromised Renal Function (creatinine ≥ 1.5 x ULNR)
- •Compromised Liver Function (bilirubin ≥ 2.5 x ULNR)
- •Exclusion Criteria:
- •Premedication with anxiolytic (e.g. midazolam, diazepam)
- •Dosed with breakthrough dose of analgesic that may contribute to control of pain during the planned procedure
研究组 & 干预措施
A
Active Comparator
干预措施: Methoxyflurane (Drug)
B
Placebo Comparator
干预措施: Normal Saline (Drug)
结局指标
主要结局
Determine where there is a difference in efficacy between Methoxyflurane and placebo for control of pain in participants undergoing a Bone Marrow Biopsy
次要结局
- Determine the safety of Methoxyflurane
研究者
研究点 (1)
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