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Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic

Information source: Tehran University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Renal Colic; Pain

Intervention: Desmopressin intranasal spray (Drug); Placebo intranasal spray (Drug); Indomethacin suppository (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Tehran University of Medical Sciences

Official(s) and/or principal investigator(s):
Mohammad Jalili, MD, Study Chair, Affiliation: Tehran University of Medical Sciences
Mohammadreza Hedayatshodeh, MD, Study Director, Affiliation: Tehran University of Medical Sciences

Overall contact:
Mohammad Jalili, MD, Phone: +98-21-66904848, Email: mjalili@tums.ac.ir

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Pain intensity

Secondary outcome: Side effects

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

Minimum age: 15 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Mohammad Jalili, MD, Phone: +98-21-66904848, Email: mjalili@tums.ac.ir

Imam Khomeini General Hospital, Tehran, Iran, Islamic Republic of; Recruiting
Mohammad Jalili, MD, Phone: 00982166904848, Email: mjalili@tums.ac.ir
Mohammadreza Hedayatshodeh, MD, Phone: 00989125357410, Email: mmd.hedy@yahoo.com
Mohammadreza Hedayatshodeh, MD, Principal Investigator

Shariati Hospital, Tehran, Iran, Islamic Republic of; Recruiting
Mohammad Jalili, MD, Phone: 00982166904848, Email: mjalili@tums.ac.ir
Mohammadreza Hedayatshodeh, MD, Principal Investigator

Additional Information

Related publications:

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.

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.

Starting date: March 2012
Last updated: December 4, 2012

Page last updated: August 23, 2015

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