Back to resultsCombination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment
Primary Purpose
Renal Colic
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Paracetamol+Morphine
Dexketoprofen plus Morphine
Placebo plus Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Renal Colic
Eligibility Criteria
Inclusion Criteria: Renal colic patients -
Exclusion Criteria: Not renal colic patients
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
Paracetamol
Dexketoprofene
Arm Description
Outcomes
Primary Outcome Measures
pain reductions in VAS scores during the 60th and 90th minutes
Secondary Outcome Measures
Need for rescue analgesic
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03865004
Brief Title
Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment
Official Title
Paracetamol Plus Morphine in ED
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 17, 2015 (Actual)
Primary Completion Date
October 17, 2016 (Actual)
Study Completion Date
October 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akdeniz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Paracetamol
Arm Type
Active Comparator
Arm Title
Dexketoprofene
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Paracetamol+Morphine
Other Intervention Name(s)
Parol
Intervention Description
1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen plus Morphine
Other Intervention Name(s)
Arveles
Intervention Description
Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously
Intervention Type
Drug
Intervention Name(s)
Placebo plus Morphine
Other Intervention Name(s)
SF
Intervention Description
100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously
Primary Outcome Measure Information:
Title
pain reductions in VAS scores during the 60th and 90th minutes
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
Need for rescue analgesic
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Renal colic patients -
Exclusion Criteria: Not renal colic patients
-
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Combination Trial of Intravenous Paracetamol - Morphine for Treating Acute Renal Colic in Emergency Setting: An Optimum Treatment
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