Safety and Efficacy of Patient Controlled Analgesia in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale
研究概览
简要总结
The aims of this study are to assess efficacy and safety of patient-controlled analgesia (PCA) when applied to the Emergency Department setting and to compare the efficacy and safety of two PCA dosing regimens.
详细描述
The safety, efficacy, and dosing of PCA will be assessed in a randomized trial with three treatment arms:
- PCA with 1.0 mg morphine demand dosing every 6 minutes,
- PCA with 1.5 mg demand dosing every 6 minutes and
- a non-PCA comparison group.
All patients will receive a loading dose of 0.1 mg/kg morphine. All patients can receive additional analgesics as needed, at the discretion of the provider.
We hypothesize that morphine supplied via PCA will provide superior analgesia without a greater incidence of adverse events when compared to non-PCA pain management; and that PCA demand dosing of 1.5 mg will be superior to 1.0 mg without more adverse events.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting to the ED with a chief complaint of abdominal pain of less than or equal to 7 days duration
- •Age 18 to 65 years
- •Patient deemed by the ED attending physician to require IV opioid analgesia
排除标准
- •Current use of prescription or non-prescription opioids
- •Long-term use of opioids, chronic pain syndrome
- •Clinician suspicion of opioid dependence/abuse
- •Clinical suspicion of intoxication
- •Pregnancy or breast-feeding
- •History of chronic obstructive pulmonary disease, history of sleep apnea, oxygen saturation < 97%
- •Systolic blood pressure < 100 mm Hg
- •Use of monoamine oxidase inhibitors, phenothiazines, or tricyclic antidepressants
- •History of renal insufficiency/renal failure
- •Prior allergic reaction to morphine
- •Inability to provide informed consent
- •Previous entry of patient into study
研究组 & 干预措施
Patient-controlled analgesia 1.5 mg demand dose
0.1 mg/kg morphine loading dose plus PCA with 1.5 mg morphine demand dosing every 6 minutes
干预措施: morphine (Drug)
Non-Patient-controlled analgesia comparison group
0.1 mg/kg morphine loading dose plus additional analgesia as needed
干预措施: morphine (Drug)
Patient-controlled analgesia 1 mg demand dose
0.1 mg/kg morphine loading dose plus PCA with 1.0 mg morphine demand dosing every 6 minutes
干预措施: Patient-controlled analgesia (Device)
Patient-controlled analgesia 1 mg demand dose
0.1 mg/kg morphine loading dose plus PCA with 1.0 mg morphine demand dosing every 6 minutes
干预措施: morphine (Drug)
Patient-controlled analgesia 1.5 mg demand dose
0.1 mg/kg morphine loading dose plus PCA with 1.5 mg morphine demand dosing every 6 minutes
干预措施: Patient-controlled analgesia (Device)
结局指标
主要结局
Short Term Efficacy: Change in Pain Intensity as Assessed by Patient Self Report on Numerical Rating Scale
时间窗: Baseline and 30 minutes post treatment
Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain. Change is measured by subtracting the 30 minute NRS score from the Baseline NRS score, thus higher numbers indicate greater decrease in pain, negative numbers indicate increase in pain from baseline to 30 minutes post-baseline.
Participants With Short Term Efficacy: Pain Relief by 30 Minutes
时间窗: 30 minutes post treatment
Pain Intensity measured on Likert Scale. Participants self report pain level according to the scale by selecting from No relief, Slight relief, Moderate relief, A lot of relief, and Complete relief)
Long Term Efficacy: Total Analgesia Provided Over 2 Hours
时间窗: Baseline, 30, 60, 90, 120 post-treatment
Participants will complete a survey in which they rate their pain on a Numerical Rating Scale (NRS) of pain ranging from 0 - no pain, to 10 - worst imaginable pain, higher scores indicate worse pain Total analgesia is measured by a summary of change in pain that varies from 0 - no change to
Long Term Efficacy: Pain Relief by 120 Minutes
时间窗: 120 minutes
Participants aksed to and give range
Safety: Incidence of Adverse Events
时间窗: 2 hours
Adverse Events defined as: oxygen saturation \< 92%; respiratory rate \<10 breaths/min; systolic blood pressure \< 90 mm Hg)
次要结局
- Need for Supplementary Analgesia(2 hours post treatment)