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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Renal Colic Drug: Paracetamol+Morphine Drug: Dexketoprofen plus Morphine Drug: Placebo plus Morphine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Paracetamol Plus Morphine in ED
Actual Study Start Date : October 17, 2015
Actual Primary Completion Date : October 17, 2016
Actual Study Completion Date : October 17, 2018

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo 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
Active Comparator: Paracetamol 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
Active Comparator: Dexketoprofene 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


Outcome Measures
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Primary Outcome Measures :
  1. pain reductions in VAS scores during the 60th and 90th minutes [ Time Frame: 60 minutes ]

Secondary Outcome Measures :
  1. Need for rescue analgesic [ Time Frame: 30 minutes ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Renal colic patients -

Exclusion Criteria: Not renal colic patients

-

Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Akdeniz University
ClinicalTrials.gov Identifier: NCT03865004    
Other Study ID Numbers: firatbektas
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colic
Renal Colic
Infant, Newborn, Diseases
Pain
Neurologic Manifestations
Acetaminophen
Dexketoprofen trometamol
Morphine
Analgesics, Opioid
Narcotics
 Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents