Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01742689
• Other study ID #: 91/130/569
• Status: Recruiting
• Phase: Phase 3
• First received: December 3, 2012
• Last updated: December 4, 2012
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: December 2012
• Source: Tehran University of Medical Sciences
• Contact: Mohammad Jalili, MD
• Phone: +98-21-66904848
• Email: mjalili[@]tums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colic
• Pain
• Renal Colic

Intervention

Drug:
• Desmopressin intranasal spray
10 microgram per puff, 40 microgram is Descript
• Placebo intranasal spray
Saline spray identical to desmopressin, administered as 4 sprays
• Indomethacin suppository
Indomethacin suppository 100 milligram single dose

Locations

Country	Name	City	State
Iran, Islamic Republic of	Imam Khomeini General Hospital	Tehran
Iran, Islamic Republic of	Shariati Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Use of opioid as a rescue drug	Whether or not the patient care team had to administer opioids due to uncontrolled pain	One hour	No
Primary	Pain intensity	Changes in pain intensity using a verbal numeric rating scale	baseline till one hour	No
Secondary	Side effects	Any perceived side effects reported by the patient, including dry mouth, nausea, and drowsiness.	One hour	Yes