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Intranasal Desmopressin vs IV Ketorolac in Renal Colic Pain Control

Primary Purpose

Renal Colic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Desmopressin
Ketorolac
Normal Saline
Normal Saline
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Colic

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • renal colic patients

Exclusion Criteria:

  • history of hypertension and cardiac disease
  • pregnant patients
  • use of analgesic within 4 hours before intervention

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Ketorolac

    Desmopressin

    Arm Description

    30mg ketorolac administrated intravenous and 4 puffs nasal Normal Saline.

    40 microgram nasal desmopressin administrated and 1cc Normal Saline intravenous

    Outcomes

    Primary Outcome Measures

    Pain score

    Secondary Outcome Measures

    Full Information

    First Posted
    October 12, 2016
    Last Updated
    October 18, 2016
    Sponsor
    Shahid Beheshti University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02937896
    Brief Title
    Intranasal Desmopressin vs IV Ketorolac in Renal Colic Pain Control
    Official Title
    Comparison of Intranasal Desmopressin vs IV Ketorolac in Renal Colic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shahid Beheshti University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is the comparison of efficacy of intravenous ketorolac and intranasal desmopressin in renal colic patients pain control.
    Detailed Description
    40 renal colic patients have been divided into 2 groups randomly, one group has been received 30mg intravenous Ketorolac and 4 puffs nasal Normal Saline while other has been received 40 micrograms nasal Desmopressin and 1cc intravenous Normal Saline. Pain Score before drug administration,also 10, 30 and 60 minutes after drug administration has been measured bye Visual Analogue Scale ( VAS ).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Colic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ketorolac
    Arm Type
    Experimental
    Arm Description
    30mg ketorolac administrated intravenous and 4 puffs nasal Normal Saline.
    Arm Title
    Desmopressin
    Arm Type
    Active Comparator
    Arm Description
    40 microgram nasal desmopressin administrated and 1cc Normal Saline intravenous
    Intervention Type
    Drug
    Intervention Name(s)
    Desmopressin
    Other Intervention Name(s)
    Ddavp
    Intervention Description
    40 micrograms Nasal Desmopressin.
    Intervention Type
    Drug
    Intervention Name(s)
    Ketorolac
    Other Intervention Name(s)
    Toradol
    Intervention Description
    30mg intravenous Ketorolac.
    Intervention Type
    Drug
    Intervention Name(s)
    Normal Saline
    Other Intervention Name(s)
    NaCl
    Intervention Description
    1cc intravenous Normal Saline.
    Intervention Type
    Drug
    Intervention Name(s)
    Normal Saline
    Other Intervention Name(s)
    NaCl
    Intervention Description
    4 puffs nasal Normal Saline.
    Primary Outcome Measure Information:
    Title
    Pain score
    Time Frame
    Pain score change from baseline pain score before intervention 10, 30 and 60 minutes after intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: renal colic patients Exclusion Criteria: history of hypertension and cardiac disease pregnant patients use of analgesic within 4 hours before intervention

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Intranasal Desmopressin vs IV Ketorolac in Renal Colic Pain Control

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