IV NSAI Versus Nebulized Morphine Analgesia for First-line Renal Colic
NCT ID: NCT02156596
Last Updated: 2020-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
100 participants
INTERVENTIONAL
2013-02-28
2018-02-28
Brief Summary
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Determine the need for systematic outpatient prescription of NSAI.
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Detailed Description
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They count for approximatively 20% of patients presenting to the ED with severe acute onset abdominal pain.
For acute treatment of renal colics (RC), guidelines recommend the use of intravenous (IV) non-steroidal anti-inflammatory (NSAI) drugs in association with antalgics like Paracetamol or Morphine.
But the NSAID present many inconvenient and cannot be used in some type of patients; that's why the investigators investigated the use of other drugs, such as nebulised morphine, in the ED treatment of renal colics.
the NM has the adequacy of being quickest, more practical to use and more tolerated than the IV NSAID.
In this study, the investigators aim to assess the feasibility, efficacity and safety of nebulised morphine compared to intravenous NSAID in the treatment of RC.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Intravenous NSAI
patients received 100 mg of ketoprofen (NSAID) by IV root and in parallel 3 nebulisation of serum saline (SS) over 30 minutes.
IV NSAI
100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root
Nebulised Serum Saline
3 nebulisations of 5ml SS each are given over 30 minutes
Nebulised Morphine
patients received 3 nebulisation of morphine (5 mg each) and in parallel 50 ml of SS by IV root over 30 minutes.
NM
3 nebulisations of 5 mg morphine chlorhydrate each given over 30 minutes (10 minutes per nebulisation)
IV Serum Saline
50 ml of SS is given by IV root over 30 minutes
Interventions
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IV NSAI
100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root
NM
3 nebulisations of 5 mg morphine chlorhydrate each given over 30 minutes (10 minutes per nebulisation)
IV Serum Saline
50 ml of SS is given by IV root over 30 minutes
Nebulised Serum Saline
3 nebulisations of 5ml SS each are given over 30 minutes
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Consenting to participate in the study
* Diagnosis of renal colic matching flank pain / lumbar fossa sided with dipstick and / or imaging confirmed the diagnosis
* VAS\> 50% at consultation
Exclusion Criteria
* Pregnant or lactating woman;
* Recognized renal disease (glomerular filtration rate \<60ml/kg/1.73m2);
* Known hepatic insufficiency;
* Known or suspected allergy to NSAIDs, morphine
* Peptic ulcer known;
16 Years
ALL
No
Sponsors
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University of Monastir
OTHER
Responsible Party
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Pr. Semir Nouira
Clinical Professor
Principal Investigators
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Nouira Semir, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Monastir
Locations
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Hospital of Fattouma Bourguiba
Monastir, , Tunisia
Countries
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Related Links
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official department site
Other Identifiers
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NSAI vs Morphine
Identifier Type: -
Identifier Source: org_study_id
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