Pharmacological Anxiolysis With Promethazine as an Adjunctive Therapy for Acute Low Back Pain in the Adult Emergency Department
试验速览
- 阶段
- 4 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Pain relief
研究概览
简要总结
Acute low back pain is a common cause for emergency department visits. Controversy remains regarding the optimal medication for acute low back pain relief. The investigators hypothesized that administration of pharmacological anxiolysis in addition to analgesia will improve pain relief and patient management in the emergency department.
详细描述
Acute low back pain is a common problem in the emergency department and pain relief is usually the first step in patients' management. Numerous medication options are available for acute LBP relief,each class of medication has its associated benefits and harms.Controversy remains regarding the optimal analgesic treatment.Anxiety has been found to be a predictive factor of pain intensity in patients with acute low back pain and anxiolysis by non-pharmacological measures has been shown to have a positive effect on pain management in the ED setting.
Promethazine is a first-generation H1 receptor antagonist of the phenothiazine chemical class used commonly as an antihistamine antiemetic. It has a strong anxiolytic-sedative effect and its safety and efficacy in managing anxiety related to medical procedures is well documented.It may be reasonable to assume that pharmacological anxiolysis with promethazine may assist in alleviation of acute pain in the strenuous environment of the ED.
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
- Double (Participant, Care Provider)
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
- •An indication for opioid analgesia based in the ED (i.e. severe pain > 70mm on a 100mm VAS)
- •Age between 18-65 years
- •American Society of Anesthesiologists (ASA) score of 1 or 2, and no preexisting glaucoma, cardiac arrhythmia or pulmonary disease
- •Systolic blood pressure higher than 90 mmHg on admission
- •Willingness and ability to provide an informed consent
- •No known hypersensitivity to the medication used.
排除标准
- •Pregnant women
- •Patients who can not be under adult supervision following discharge from the emergency department.
研究组 & 干预措施
Morphine-Promethazine
Pain relief by administration of morphine-promethazine combination
干预措施: Morphine-Promethazine (Drug)
morphine
pain relief by administration of morphine
干预措施: morphine (Drug)
结局指标
主要结局
Pain relief
时间窗: Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital)
Pain scores before and after treatment will be assessed on a 100mm VAS. The difference will be regarded as pain relief.
次要结局
- Ambulatory status(Up to 24 hours (before analgesia administration and on discharge from the ED or admission to the hospital))