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
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Sponsor:
Akdeniz University
Information provided by (Responsible Party):
Akdeniz University
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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 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 |
Resource links provided by the National Library of Medicine

Drug Information available for:
Morphine sulfate
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 |
Primary Outcome Measures :
- pain reductions in VAS scores during the 60th and 90th minutes [ Time Frame: 60 minutes ]
Secondary Outcome Measures :
- Need for rescue analgesic [ Time Frame: 30 minutes ]
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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
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No Contacts or Locations Provided
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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 |