Renal Colic
Conditions
Keywords
renal colic, nebulised morphine, Intravenous NSAID
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 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.
Interventions
DRUGIV NSAI
100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root
DRUGNM
3 nebulisations of 5 mg morphine chlorhydrate each given over 30 minutes (10 minutes per nebulisation)
DRUGIV Serum Saline
50 ml of SS is given by IV root over 30 minutes
DRUGNebulised Serum Saline
3 nebulisations of 5ml SS each are given over 30 minutes
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| efficacity: VAS pain reduction | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| feasibility of the study: number of patients accepting the adhesion to protocol | 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 | 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. |
Countries
Tunisia
Outcome results
None listed