Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic
- Conditions
- PainRenal Colic
- Interventions
- Registration Number
- NCT01742689
- Lead Sponsor
- Tehran University of Medical Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 88
- Age: 15 to 65 years
- Pain intensity of at least 3
- Clinical diagnosis of renal colic
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Desmopressin intranasal spray Desmopressin intranasal spray Patients in this arm will receive 40 microgram desmopressin intranasal spray \& 100 milligram indomethacin suppository Placebo intranasal spray Placebo intranasal spray Patients in this group will receive placebo nasal spray \& 100 milligram indomethacin suppository Desmopressin intranasal spray Indomethacin suppository Patients in this arm will receive 40 microgram desmopressin intranasal spray \& 100 milligram indomethacin suppository Placebo intranasal spray Indomethacin suppository Patients in this group will receive placebo nasal spray \& 100 milligram indomethacin suppository
- Primary Outcome Measures
Name Time Method Pain intensity baseline till one hour Changes in pain intensity using a verbal numeric rating scale
- Secondary Outcome Measures
Name Time Method Side effects One hour Any perceived side effects reported by the patient, including dry mouth, nausea, and drowsiness.
Trial Locations
- Locations (2)
Imam Khomeini General Hospital
🇮🇷Tehran, Iran, Islamic Republic of
Shariati Hospital
🇮🇷Tehran, Iran, Islamic Republic of