Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain; Renal Colic
• Intervention / Treatment: Drug: Desmopressin intranasal spray; Drug: Indomethacin suppository; Drug: Placebo intranasal spray

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.

• Study Type: Interventional
• Enrollment (Anticipated): 88
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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: Indomethacin suppository; Indomethacin suppository 100 milligram single dose; Other Names: Indocin; Indocid; Indochron; INDOMET; Drug: Placebo intranasal spray; Saline spray identical to desmopressin, administered as 4 sprays

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Changes in pain intensity using a verbal numeric rating scale	baseline till one hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	Any perceived side effects reported by the patient, including dry mouth, nausea, and drowsiness.	One hour

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of opioid as a rescue drug	Whether or not the patient care team had to administer opioids due to uncontrolled pain	One hour

Collaborators and Investigators

• Sponsor: Tehran University of Medical Sciences
• Investigators: Study Director: Mohammadreza Hedayatshodeh, MD, Tehran University of Medical Sciences

Publications and helpful links

General 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. doi: 10.1046/j.1464-410x.2001.00068.x.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Anticipated): March 1, 2013
• Study Completion (Anticipated): March 1, 2013

Study Registration Dates

• First Submitted: December 3, 2012
• First Submitted That Met QC Criteria: December 4, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Estimate): December 5, 2012
• Last Update Submitted That Met QC Criteria: December 4, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Pain; Desmopressin; Indomethacin; Urinary obstruction; Renal colic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Infant, Newborn, Diseases; Renal Colic; Colic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Natriuretic Agents; Hemostatics; Coagulants; Reproductive Control Agents; Gout Suppressants; Tocolytic Agents; Antidiuretic Agents; Indomethacin; Deamino Arginine Vasopressin
• Other Study ID Numbers: 91/130/569