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CompletedNCT02156596

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

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.

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
100 (actual)
Sponsor
University of Monastir · Academic / Other
Sex
All
Age
16 Years
Healthy volunteers
Not accepted

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 description

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.

Conditions

Interventions

TypeNameDescription
DRUGIV NSAI100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root
DRUGNM3 nebulisations of 5 mg morphine chlorhydrate each given over 30 minutes (10 minutes per nebulisation)
DRUGIV Serum Saline50 ml of SS is given by IV root over 30 minutes
DRUGNebulised Serum Saline3 nebulisations of 5ml SS each are given over 30 minutes

Timeline

Start date
2013-02-01
Primary completion
2017-12-01
Completion
2018-02-01
First posted
2014-06-05
Last updated
2020-02-11

Locations

1 site across 1 country: Tunisia

Source: ClinicalTrials.gov record NCT02156596. Inclusion in this directory is not an endorsement.

IV NSAI Versus Nebulized Morphine Analgesia for First-line Renal Colic (NCT02156596) · Clinical Trials Directory