Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic

Last updated: December 4, 2012
Sponsor: Tehran University of Medical Sciences
Overall Status: Trial Status Unknown

Phase

3

Condition

Pain

Colic

Kidney Stones

Treatment

N/A

Clinical Study ID

NCT01742689
91/130/569
  • Ages 15-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: 15 to 65 years

  • Pain intensity of at least 3

  • Clinical diagnosis of renal colic

Exclusion

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

Study Design

Total Participants: 88
Study Start date:
March 01, 2012
Estimated Completion Date:
March 31, 2013

Study 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.

Connect with a study center

  • Imam Khomeini General Hospital

    Tehran,
    Iran, Islamic Republic of

    Active - Recruiting

  • Shariati Hospital

    Tehran,
    Iran, Islamic Republic of

    Active - Recruiting

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