The Analgesic Effects of Morphine Versus Ketorolac in Low Back Pain
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 主要终点
- Reducing the grade of pain
研究概览
简要总结
The study is prospective, double blinded, randomised controlled and has the purpose to compare the analgesic effects of ketorolac or morphine intravenous in low back pain.
详细描述
The study will take place in the Emergency Department of the Clinical Emergency Hospital Bucharest and will compare the analgesic effects of ketorolac tromethamine against morphine in low back pain.
The patients will be randomised to receive either ketorolac 30 mg intravenous (diluted in 20 ml of 0,9% saline) or morphine 0,1 mg/kg weight intravenous. A scale of 1-10 will be used for measuring the pain, and the effects of the treatment will be evaluated at 15 minutes and 30 minutes from the administration of the drugs. After 30 minutes if there is no significant reduction of the pain a rescue therapy will be used : acetaminophen 1 g, sodic metamizole 1g both diluted in 500 ml saline and the other medication not used from the study (morphine or ketorolac tromethamine).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •clinical diagnosis of musculoskeletal low back pain
- •grade 5 pain on a 1-10 visual pain scale
排除标准
- •contraindications of ketorolac or opioids
- •pregnancy
- •known allergies to ketorolac or opioids
- •post-traumatic low back pain
- •refusal of participation
研究组 & 干预措施
Ketorolac
The patients randomised to this arm will receive 30 mg intravenous ketorolac.
干预措施: Morphine (Drug)
Morphine
The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine.
干预措施: Ketorolac (Drug)
结局指标
主要结局
Reducing the grade of pain
时间窗: 15 minutes, 30 minutes
To see the reducing of the pain on a scale 1-10 at two time points
次要结局
- Time of staying in emergency department(30 minutes, 1 hour, 2 hours, 3 hours)
- The necessity neurosurgery consult - questionnaire(1 month)
- The cost of each treatment(1 hour)
- The necessity to use rescue therapy(30 minutes)
- Side effects of each treatment(30 minutes)
研究者
Loredana Ghinea
Medical Doctor
Bucharest Emergency Hospital