Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic - Full Text View

Purpose

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.

Condition	Intervention	Phase
Renal Colic Pain	Drug: Desmopressin intranasal spray Drug: Placebo intranasal spray Drug: Indomethacin suppository	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Assessment of Analgesic Efficacy of Intranasal Desmopressin in the Treatment of Acute Pain in Patients With Renal Colic

Resource links provided by NLM:

Drug Information available for: Indomethacin Desmopressin Desmopressin acetate

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:

Pain intensity [ Time Frame: baseline till one hour ] [ Designated as safety issue: No ]
Changes in pain intensity using a verbal numeric rating scale

Secondary Outcome Measures:

Side effects [ Time Frame: One hour ] [ Designated as safety issue: Yes ]
Any perceived side effects reported by the patient, including dry mouth, nausea, and drowsiness.

Other Outcome Measures:

Use of opioid as a rescue drug [ Time Frame: One hour ] [ Designated as safety issue: No ]
Whether or not the patient care team had to administer opioids due to uncontrolled pain

Estimated Enrollment:	88
Study Start Date:	March 2012
Estimated Study Completion Date:	March 2013
Estimated Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Desmopressin intranasal spray Patients in this arm will receive 40 microgram desmopressin intranasal spray & 100 milligram indomethacin suppository	Drug: Desmopressin intranasal spray 10 microgram per puff, 40 microgram is Descript Other Name: DDAVP, DesmoMelt, Stimate, Minirin,Desmex Drug: Indomethacin suppository Indomethacin suppository 100 milligram single dose Other Names: Indocin Indocid Indochron INDOMET
Placebo Comparator: Placebo intranasal spray Patients in this group will receive placebo nasal spray & 100 milligram indomethacin suppository	Drug: Placebo intranasal spray Saline spray identical to desmopressin, administered as 4 sprays Drug: Indomethacin suppository Indomethacin suppository 100 milligram single dose Other Names: Indocin Indocid Indochron INDOMET

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

Ages Eligible for Study:	15 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01742689

Contacts

Contact: Mohammad Jalili, MD

+98-21-66904848

mjalili@tums.ac.ir

Locations

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

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

Study Chair:	Mohammad Jalili, MD	Tehran University of Medical Sciences
Study Director:	Mohammadreza Hedayatshodeh, MD	Tehran University of Medical Sciences

More Information

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. 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.

Responsible Party:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT01742689 History of Changes
Other Study ID Numbers:	91/130/569
Study First Received:	December 3, 2012
Last Updated:	December 4, 2012
Health Authority:	Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:

Renal colic
Pain
Desmopressin
Urinary obstruction
Indomethacin

Additional relevant MeSH terms:

Renal Colic
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive
Analgesics
Indomethacin
Deamino Arginine Vasopressin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Antidiuretic Agents
Natriuretic Agents
Hemostatics
Coagulants
Hematologic Agents
Cardiovascular Agents
Gout Suppressants
Antirheumatic Agents
Tocolytic Agents
Reproductive Control Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on May 21, 2013