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Analgesic Efficacy of Intranasal Desmopressin in Acute Renal Colic

NCT ID: NCT01742689

Last Updated: 2012-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Renal Colic Pain

Keywords

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Renal colic Pain Desmopressin Urinary obstruction Indomethacin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Desmopressin intranasal spray

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

Group Type EXPERIMENTAL

Desmopressin intranasal spray

Intervention Type DRUG

10 microgram per puff, 40 microgram is Descript

Indomethacin suppository

Intervention Type DRUG

Indomethacin suppository 100 milligram single dose

Placebo intranasal spray

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

Group Type PLACEBO_COMPARATOR

Placebo intranasal spray

Intervention Type DRUG

Saline spray identical to desmopressin, administered as 4 sprays

Indomethacin suppository

Intervention Type DRUG

Indomethacin suppository 100 milligram single dose

Interventions

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Desmopressin intranasal spray

10 microgram per puff, 40 microgram is Descript

Intervention Type DRUG

Placebo intranasal spray

Saline spray identical to desmopressin, administered as 4 sprays

Intervention Type DRUG

Indomethacin suppository

Indomethacin suppository 100 milligram single dose

Intervention Type DRUG

Other Intervention Names

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DDAVP, DesmoMelt, Stimate, Minirin,Desmex Indocin Indocid Indochron INDOMET

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad Jalili, MD

Role: STUDY_CHAIR

Tehran University of Medical Sciences

Mohammadreza Hedayatshodeh, MD

Role: STUDY_DIRECTOR

Tehran University of Medical Sciences

Locations

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Imam Khomeini General Hospital

Tehran, Tehran Province, Iran

Site Status RECRUITING

Shariati Hospital

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Mohammad Jalili, MD

Role: CONTACT

Phone: +98-21-66904848

Email: [email protected]

Facility Contacts

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Mohammad Jalili, MD

Role: primary

Mohammadreza Hedayatshodeh, MD

Role: backup

Mohammad Jalili, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 19962730 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11251523 (View on PubMed)

Other Identifiers

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91/130/569

Identifier Type: -

Identifier Source: org_study_id