Prehospital Analgesia in Adults Using Inhaled (PAIN) Methoxyflurane : A Feasibility Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Time to ethics approval for single site
研究概览
简要总结
Pain is common and can contribute to both psychological and physiological effects if not treated. Currently primary care paramedics have limited selections within their pain management tool box. This contributes to inadequate pain management. Methoxyflurane is a safe, easy and effective choice in prehospital management of pain. The impact of this feasibility trial, will hope to inform the larger multi-centred trial and then support the implementation of out-of-hospital Canadian National Guidelines for prehospital pain control, enabling paramedics to provide rapid, effective prehospital pain relief to patients.
详细描述
This will be a single-centred prehospital prospective observational feasibility study to evaluate the ability to perform a multicentred step wedge design trial. The feasibility outcomes will provide evidence for the development of the multicentred study and will capture clinical metrics to inform this larger study. A waver of consent will be sought from the ethics board with participation consent for paramedics understanding the risk of using a gas for analgesia. Patient >= 18 years of age with traumatic pain with a verbal score >= to 4 will be enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •>=18 years of age
- •Acute pain from traumatic injury
- •numeric pain score >=4
排除标准
- •Allergy or sensitivity to methoxyflurane
- •History or family history of malignant hyperthermia
- •Pregnant or breast-feeding patients
- •Known renal impairment
- •Known liver disease
- •Methoxyflurane use within previous 3 months
研究组 & 干预措施
intervention Arm
Methoxyflurane will be introduced and data will be captured to inform future multicentred step wedge design study. (This study is a feasibility study)
干预措施: Methoxyflurane (Drug)
结局指标
主要结局
Time to ethics approval for single site
时间窗: from ethics submission up to 90 days
Target: ,\<= 3 months (90 days) from ethics submission
Evaluation of outcome data collected
时间窗: For length of study, up to 100 patients
Target: 100% of data captured in \>90% cases
Time to readiness to initiate the clinical trial
时间窗: From ethics approval up to 90 days
Target, \<= 3 months (90 days) from ethics approval
Study protocol compliance by paramedics
时间窗: For length of study, up to 100 patients
Target, \>= 80%
次要结局
- Transport time(For length of study, up to 100 patients, specifically departure scene to arrival at hospital)
- Time to first administration of methoxyflurane(For length of study, up to 100 patients. Specifically time from patient contact to first inhalation of methoxyflurane)
- Verbal numeric pain rating score (0-10) initial and recorded every 5 minutes(For length of study, up to 100 patients specifically from patient contact to transfer of care in the emergency department)
- Vital signs and level of consciousness(From patient contact to transfer of care)
- Need for rescue medication (as defined by addition of any other pain medication after methoxyflurane administration, during paramedic care)(For length of study, up to 100 patients. specifically from patient contact to transfer of care in the emergency department)
- Adverse events post administration of methoxyflurane:(For length of study, up to 100 patients. Specifically from patient contact to transfer of care)