Trials / Completed
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
| Type | Name | Description |
|---|---|---|
| DRUG | IV NSAI | 100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root |
| DRUG | NM | 3 nebulisations of 5 mg morphine chlorhydrate each given over 30 minutes (10 minutes per nebulisation) |
| DRUG | IV Serum Saline | 50 ml of SS is given by IV root over 30 minutes |
| DRUG | Nebulised Serum Saline | 3 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.