Assessment of Analgesic Efficacy of Intranasal Desmopressin in the Treatment of Acute Pain in Patients With Renal Colic
试验速览
- 阶段
- 3 期
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
In this study we will compare pain intensity and side effects at different time points after the intranasal administration of desmopressin or placebo in patients with acute renal colic pain.
详细描述
Obstruction of the urinary tract can increase pelvi-ureteric pressure and thus cause renal colic pain, which can be very severe. Conventional therapy consists of non-steroidal anti-inflammatory drugs (NSAIDs) and opioids. NSAIDs have many side effects and opioids are not always available. In addition, the intravenous form of NSAIDs is not routinely available in Iran, and the drug is mainly used in the form of suppository. Due to these reasons, research on newer replacement therapies with fewer side effects is necessary. Desmopressin intranasal spray has already been shown to be partially effective in renal colic pain in a few studies. Due to its lower side effects, we decided to conduct a clinical trial with desmopressin to evaluate pain relief in renal colic. In this study, eighty-eight patients with acute renal colic pain, referring to Imam Khomeini Hospital in Tehran, will be randomly allocated to receive either intranasal desmopressin or placebo. Both groups will also receive 100 milligram indomethacin suppository. Pain intensity will be assessed and recorded using a verbal numeric rating scale, before nasal spray, and in minutes 5, 10, 15, 30, 45 and 60 after receiving the allocated treatment. Possible side effects will also be asked and recorded. The patient and the investigator responsible for recording pain intensity will not be aware of the administered drug. The results will be compared before and after treatment in each group, using appropriate statistical tests.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 15 to 65 years
- •Pain intensity of at least 3
- •Clinical diagnosis of renal colic
排除标准
- •History of hypertension
- •History of acute myocardial ischemia
- •History of hyponatremia
- •Presence of acute rhinitis and flu
- •Coagulopathy or anticoagulant therapy
- •History of peptic ulcer disease, asthma, renal failure, severe liver failure
- •Analgesic use over 4 hours ago
- •Taking seizure medications (such as carbamazepine)
- •Taking any of the following drugs: chlorpropamide, warfarin, clofibrate , epinephrine, Fludrocortisone, heparin, lithium, alcohol
研究组 & 干预措施
Desmopressin intranasal spray
Patients in this arm will receive 40 microgram desmopressin intranasal spray & 100 milligram indomethacin suppository
干预措施: Desmopressin intranasal spray (Drug)
Desmopressin intranasal spray
Patients in this arm will receive 40 microgram desmopressin intranasal spray & 100 milligram indomethacin suppository
干预措施: Indomethacin suppository (Drug)
Placebo intranasal spray
Patients in this group will receive placebo nasal spray & 100 milligram indomethacin suppository
干预措施: Placebo intranasal spray (Drug)
Placebo intranasal spray
Patients in this group will receive placebo nasal spray & 100 milligram indomethacin suppository
干预措施: Indomethacin suppository (Drug)
结局指标
主要结局
Pain intensity
时间窗: baseline till one hour
Changes in pain intensity using a verbal numeric rating scale
次要结局
- Side effects(One hour)