Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Renal Colic, Pain

Intervention / Treatment
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* Drug: Desmopressin intranasal spray
* Drug: Placebo intranasal spray
* Drug: Indomethacin suppository


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desmopressin intranasal spray<br>Patients in this arm will receive 40 microgram desmopressin intranasal spray & 100 milligram indomethacin suppository | Drug: Desmopressin intranasal spray<br>* 10 microgram per puff, 40 microgram is Descript<br>* Other names: DDAVP, DesmoMelt, Stimate, Minirin,Desmex;Drug: Indomethacin suppository<br>* Indomethacin suppository 100 milligram single dose<br>* Other names: INDOMET;|
| Placebo Comparator: Placebo intranasal spray<br>Patients in this group will receive placebo nasal spray & 100 milligram indomethacin suppository | Drug: Placebo intranasal spray<br>* Saline spray identical to desmopressin, administered as 4 sprays<br>Drug: Indomethacin suppository<br>* Indomethacin suppository 100 milligram single dose<br>* Other names: INDOMET;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Changes in pain intensity using a verbal numeric rating scale | baseline till one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | Any perceived side effects reported by the patient, including dry mouth, nausea, and drowsiness. | One hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal colic, Pain, Desmopressin, Urinary obstruction, Indomethacin