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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Renal Colic

Intervention / Treatment
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* Drug: IV NSAI
* Drug: NM
* Drug: IV Serum Saline
* Drug: Nebulised Serum Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 16 years old 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: Inability to assess pain VAS; 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;

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous NSAI<br>patients received 100 mg of ketoprofen (NSAID) by IV root and in parallel 3 nebulisation of serum saline (SS) over 30 minutes. | Drug: IV NSAI<br>* 100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root<br>* Other names: ketoprofen IV;Drug: Nebulised Serum Saline<br>* 3 nebulisations of 5ml SS each are given over 30 minutes<br>* Other names: serum saline;|
| Experimental: Nebulised Morphine<br>patients received 3 nebulisation of morphine (5 mg each) and in parallel 50 ml of SS by IV root over 30 minutes. | Drug: NM<br>* 3 nebulisations of 5 mg morphine chlorhydrate each given over 30 minutes (10 minutes per nebulisation)<br>* Other names: morphine;Drug: IV Serum Saline<br>* 50 ml of SS is given by IV root over 30 minutes<br>* Other names: serum saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacity: VAS pain reduction | 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. | 5, 15, 30, 45 and 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of the study: number of patients accepting the adhesion to protocol | 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). | at base line and at 60 minutes | 
| safety: side effects of treatment | 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. | 5, 15, 30, 45 and 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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renal colic, nebulised morphine, Intravenous NSAID