Clinical Trial: IV NSAI Versus Nebulized Morphine Analgesia for First-line Renal Colic

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Intravenous Treatment With Non Steroidal Anti Inflammatory Drugs (NSAID) Versus Nebulized Morphine (NM) Analgesia for First-line Renal Colic: Randomized Controlled Double-

Brief Summary:

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.


Detailed Summary:

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.


Sponsor: University of Monastir

Current Primary Outcome: efficacity: VAS pain reduction [ 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • feasibility of the study: number of patients accepting the adhesion to protocol [ 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).
  • safety: side effects of treatment [ 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.



Original Secondary Outcome: Same as current

Information By: University of Monastir

Dates:
Date Received: June 3, 2014
Date Started: February 2013
Date Completion: February 2018
Last Updated: April 1, 2016
Last Verified: April 2016