Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic

Tehran University of Medical Sciences

Status and phase: Unknown; Phase 3

Conditions: Pain; Renal Colic

Treatments: Drug: Desmopressin intranasal spray; Drug: Placebo intranasal spray; Drug: Indomethacin suppository

Study type: Interventional

Funder types: Other

Identifiers

NCT01742689

91/130/569

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 15 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups, including a placebo group

Desmopressin intranasal spray

Experimental group

Description:

Patients in this arm will receive 40 microgram desmopressin intranasal spray \& 100 milligram indomethacin suppository

Treatment:

Drug: Indomethacin suppository

Drug: Desmopressin intranasal spray

Placebo intranasal spray

Placebo Comparator group

Description:

Patients in this group will receive placebo nasal spray \& 100 milligram indomethacin suppository

Treatment:

Drug: Indomethacin suppository

Drug: Placebo intranasal spray