Clinical Trial: Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic

Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Assessment of Analgesic Efficacy of Intranasal Desmopressin in the Treatment of Acute Pain in Patients With Renal Colic

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 Summary: 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.
Sponsor: Tehran University of Medical Sciences

Current Primary Outcome: Pain intensity [ Time Frame: baseline till one hour ]

Changes in pain intensity using a verbal numeric rating scale


Original Primary Outcome: Same as current

Current Secondary Outcome: Side effects [ Time Frame: One hour ]

Any perceived side effects reported by the patient, including dry mouth, nausea, and drowsiness.


Original Secondary Outcome: Same as current

Information By: Tehran University of Medical Sciences

Dates:
Date Received: December 3, 2012
Date Started: March 2012
Date Completion: March 2013
Last Updated: December 4, 2012
Last Verified: December 2012