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Trial record 91 of 469 for:    KETOROLAC

Intranasal Desmopressin vs IV Ketorolac in Renal Colic Pain Control

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ClinicalTrials.gov Identifier: NCT02937896
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
Kambiz Nasiri, Shahid Beheshti University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE October 12, 2016
First Posted Date  ICMJE October 19, 2016
Last Update Posted Date October 19, 2016
Study Start Date  ICMJE January 2015
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 18, 2016)
Pain score [ Time Frame: Pain score change from baseline pain score before intervention 10, 30 and 60 minutes after intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Desmopressin vs IV Ketorolac in Renal Colic Pain Control
Official Title  ICMJE Comparison of Intranasal Desmopressin vs IV Ketorolac in Renal Colic Patients
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 ).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Renal Colic
Intervention  ICMJE
  • Drug: Desmopressin
    40 micrograms Nasal Desmopressin.
    Other Name: Ddavp
  • Drug: Ketorolac
    30mg intravenous Ketorolac.
    Other Name: Toradol
  • Drug: Normal Saline
    1cc intravenous Normal Saline.
    Other Name: NaCl
  • Drug: Normal Saline
    4 puffs nasal Normal Saline.
    Other Name: NaCl
Study Arms  ICMJE
  • Experimental: Ketorolac
    30mg ketorolac administrated intravenous and 4 puffs nasal Normal Saline.
    Interventions:
    • Drug: Ketorolac
    • Drug: Normal Saline
  • Active Comparator: Desmopressin
    40 microgram nasal desmopressin administrated and 1cc Normal Saline intravenous
    Interventions:
    • Drug: Desmopressin
    • Drug: Normal Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2016)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • renal colic patients

Exclusion Criteria:

  • history of hypertension and cardiac disease
  • pregnant patients
  • use of analgesic within 4 hours before intervention
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02937896
Other Study ID Numbers  ICMJE 688
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Kambiz Nasiri, Shahid Beheshti University of Medical Sciences
Study Sponsor  ICMJE Shahid Beheshti University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shahid Beheshti University of Medical Sciences
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP