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Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03865004
Recruitment Status : Completed
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
Akdeniz University

Tracking Information
First Submitted Date  ICMJE March 4, 2019
First Posted Date  ICMJE March 6, 2019
Last Update Posted Date March 6, 2019
Actual Study Start Date  ICMJE October 17, 2015
Actual Primary Completion Date October 17, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
pain reductions in VAS scores during the 60th and 90th minutes [ Time Frame: 60 minutes ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
Need for rescue analgesic [ Time Frame: 30 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment
Official Title  ICMJE Paracetamol Plus Morphine in ED
Brief Summary This randomized, placebo-controlled trial evaluated the analgesic efficacy and safety of intravenous morphine-paracetamol combination and morphine-dexketoprofen combination morphine for the optimum treatment of renal colic. Combination of IV morphine and paracetamol is as effective and rapid as combination of IV Morphine and IV dexketoprophen for optimum treating of renal colic.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Renal Colic
Intervention  ICMJE
  • Drug: Paracetamol+Morphine
    1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously
    Other Name: Parol
  • Drug: Dexketoprofen plus Morphine
    Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously
    Other Name: Arveles
  • Drug: Placebo plus Morphine
    100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously
    Other Name: SF
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Paracetamol+Morphine
    • Drug: Dexketoprofen plus Morphine
    • Drug: Placebo plus Morphine
  • Active Comparator: Paracetamol
    Interventions:
    • Drug: Paracetamol+Morphine
    • Drug: Dexketoprofen plus Morphine
    • Drug: Placebo plus Morphine
  • Active Comparator: Dexketoprofene
    Interventions:
    • Drug: Paracetamol+Morphine
    • Drug: Dexketoprofen plus Morphine
    • Drug: Placebo plus Morphine
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: March 5, 2019)
136
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 17, 2018
Actual Primary Completion Date October 17, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Renal colic patients -

Exclusion Criteria: Not renal colic patients

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (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 NCT03865004
Other Study ID Numbers  ICMJE firatbektas
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Akdeniz University
Study Sponsor  ICMJE Akdeniz University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Akdeniz University
Verification Date March 2019

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