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Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic

Primary Purpose

Renal Colic, Pain

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Desmopressin intranasal spray
Placebo intranasal spray
Indomethacin suppository
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Colic focused on measuring Renal colic, Pain, Desmopressin, Urinary obstruction, Indomethacin

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Imam Khomeini General HospitalRecruiting
  • Shariati HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Desmopressin intranasal spray

Placebo intranasal spray

Arm Description

Patients in this arm will receive 40 microgram desmopressin intranasal spray & 100 milligram indomethacin suppository

Patients in this group will receive placebo nasal spray & 100 milligram indomethacin suppository

Outcomes

Primary Outcome Measures

Pain intensity
Changes in pain intensity using a verbal numeric rating scale

Secondary Outcome Measures

Side effects
Any perceived side effects reported by the patient, including dry mouth, nausea, and drowsiness.

Full Information

First Posted
December 3, 2012
Last Updated
December 4, 2012
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01742689
Brief Title
Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic
Official Title
Assessment of Analgesic Efficacy of Intranasal Desmopressin in the Treatment of Acute Pain in Patients With Renal Colic
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic, Pain
Keywords
Renal colic, Pain, Desmopressin, Urinary obstruction, Indomethacin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Desmopressin intranasal spray
Arm Type
Experimental
Arm Description
Patients in this arm will receive 40 microgram desmopressin intranasal spray & 100 milligram indomethacin suppository
Arm Title
Placebo intranasal spray
Arm Type
Placebo Comparator
Arm Description
Patients in this group will receive placebo nasal spray & 100 milligram indomethacin suppository
Intervention Type
Drug
Intervention Name(s)
Desmopressin intranasal spray
Other Intervention Name(s)
DDAVP, DesmoMelt, Stimate, Minirin,Desmex
Intervention Description
10 microgram per puff, 40 microgram is Descript
Intervention Type
Drug
Intervention Name(s)
Placebo intranasal spray
Intervention Description
Saline spray identical to desmopressin, administered as 4 sprays
Intervention Type
Drug
Intervention Name(s)
Indomethacin suppository
Other Intervention Name(s)
Indocin, Indocid, Indochron, INDOMET
Intervention Description
Indomethacin suppository 100 milligram single dose
Primary Outcome Measure Information:
Title
Pain intensity
Description
Changes in pain intensity using a verbal numeric rating scale
Time Frame
baseline till one hour
Secondary Outcome Measure Information:
Title
Side effects
Description
Any perceived side effects reported by the patient, including dry mouth, nausea, and drowsiness.
Time Frame
One hour
Other Pre-specified Outcome Measures:
Title
Use of opioid as a rescue drug
Description
Whether or not the patient care team had to administer opioids due to uncontrolled pain
Time Frame
One hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Jalili, MD
Phone
+98-21-66904848
Email
mjalili@tums.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Jalili, MD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mohammadreza Hedayatshodeh, MD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Imam Khomeini General Hospital
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Jalili, MD
Phone
00982166904848
Email
mjalili@tums.ac.ir
First Name & Middle Initial & Last Name & Degree
Mohammadreza Hedayatshodeh, MD
Phone
00989125357410
Email
mmd.hedy@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mohammadreza Hedayatshodeh, MD
Facility Name
Shariati Hospital
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammad Jalili, MD
Phone
00982166904848
Email
mjalili@tums.ac.ir
First Name & Middle Initial & Last Name & Degree
Mohammadreza Hedayatshodeh, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
19962730
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.
Results Reference
background
PubMed Identifier
11251523
Citation
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.
Results Reference
background

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Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic

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