Clinical trial NCT01742689: Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic
Official title: Assessment of Analgesic Efficacy of Intranasal Desmopressin in the Treatment of Acute Pain in Patients With Renal Colic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Renal Colic
Pain
Keywords: Renal colic
Pain
Desmopressin
Urinary obstruction
Indomethacin
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-12-05
Enrollment: 88
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Age: 15 to 65 years
* Pain intensity of at least 3
* Clinical diagnosis of renal colic

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain intensity
timeFrame: baseline till one hour
Secondary outcomes:
measure: Side effects
timeFrame: One hour
Other outcomes:
measure: Use of opioid as a rescue drug
timeFrame: One hour
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Khomeini General Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: Shariati Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Mohammad Jalili, MD
role: STUDY_CHAIR
affiliation: Tehran University of Medical Sciences
name: Mohammadreza Hedayatshodeh, MD
role: STUDY_DIRECTOR
References:
citation: Roshani A, Falahatkar S, Khosropanah I, Roshan ZA, Zarkami T, Palizkar M, Emadi SA, Akbarpour M, Khaki N. Assessment of clinical efficacy of intranasal desmopressin spray and diclofenac sodium suppository in treatment of renal colic versus diclofenac sodium alone. Urology. 2010 Mar;75(3):540-2. doi: 10.1016/j.urology.2008.05.053. Epub 2009 Dec 4.
citation: Lopes T, Dias JS, Marcelino J, Varela J, Ribeiro S, Dias J. An assessment of the clinical efficacy of intranasal desmopressin spray in the treatment of renal colic. BJU Int. 2001 Mar;87(4):322-5. doi: 10.1046/j.1464-410x.2001.00068.x.