Hospital of Fattouma Bourguiba
Monastir, 5000, Tunisia
NCT Number: NCT02156596
The aim of the investigators study was to evaluate the feasibility, efficacy and safety of nebulized morphine compared with non-steroidal anti-inflammatory (NSAI)intravenously in the management of renal colic.
Determine the need for systematic outpatient prescription of NSAI.
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Notify Me16 year and older
All sexes
Interventional
Phase 1
Monastir, 5000, Tunisia
Renal colic are a frequent cause of consultation in the emergency departement (ED).
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root
Other names: ketoprofen IV
3 nebulisations of 5 mg morphine chlorhydrate each given over 30 minutes (10 minutes per nebulisation)
Other names: morphine
50 ml of SS is given by IV root over 30 minutes
Other names: serum saline
3 nebulisations of 5ml SS each are given over 30 minutes
Other names: serum saline
Time frame: 5, 15, 30, 45 and 60 minutes
The effectiveness of treatment is defined by a decrease in the intensity of pain corresponding to a decrease of the VAS above 50% at 60 minutes compared to baseline.
Time frame: at base line and at 60 minutes
the feasibility is assessed by comparing the number of patients accepting the protocol to the total number of patients consulting for RC; and the number of patients that actually completed the protocol course (if above 50%, the protocol is considered feasable).
Time frame: 5, 15, 30, 45 and 60 minutes
the safety of treatment is evaluated by the occurence of side effects at any time of the protocol.
only major side effects (repeated vomiting, untolerated dizziness, conscience troubles, dyspnea and allergic reaction) are admitted to stop the protocol.
University of Monastir
Other
Intravenous Treatment With Non Steroidal Anti Inflammatory Drugs (NSAID) Versus Nebulized Morphine (NM) Analgesia for First-line Renal Colic: Randomized Controlled Double-blind Single-center Study.
Acronym: NSAIvsNM
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