IV NSAI Versus Nebulized Morphine Analgesia for First-line Renal Colic (NSAIvsNM)
Primary Purpose
Renal Colic
Status
Completed
Phase
Phase 1
Locations
Tunisia
Study Type
Interventional
Intervention
IV NSAI
NM
IV Serum Saline
Nebulised Serum Saline
Sponsored by
About this trial
This is an interventional treatment trial for Renal Colic focused on measuring renal colic, nebulised morphine, Intravenous NSAID
Eligibility Criteria
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;
Sites / Locations
- Hospital of Fattouma Bourguiba
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Intravenous NSAI
Nebulised Morphine
Arm Description
patients received 100 mg of ketoprofen (NSAID) by IV root and in parallel 3 nebulisation of serum saline (SS) over 30 minutes.
patients received 3 nebulisation of morphine (5 mg each) and in parallel 50 ml of SS by IV root over 30 minutes.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02156596
Brief Title
IV NSAI Versus Nebulized Morphine Analgesia for First-line Renal Colic
Acronym
NSAIvsNM
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Monastir
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Colic
Keywords
renal colic, nebulised morphine, Intravenous NSAID
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous NSAI
Arm Type
Active Comparator
Arm Description
patients received 100 mg of ketoprofen (NSAID) by IV root and in parallel 3 nebulisation of serum saline (SS) over 30 minutes.
Arm Title
Nebulised Morphine
Arm Type
Experimental
Arm Description
patients received 3 nebulisation of morphine (5 mg each) and in parallel 50 ml of SS by IV root over 30 minutes.
Intervention Type
Drug
Intervention Name(s)
IV NSAI
Other Intervention Name(s)
ketoprofen IV
Intervention Description
100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root
Intervention Type
Drug
Intervention Name(s)
NM
Other Intervention Name(s)
morphine
Intervention Description
3 nebulisations of 5 mg morphine chlorhydrate each given over 30 minutes (10 minutes per nebulisation)
Intervention Type
Drug
Intervention Name(s)
IV Serum Saline
Other Intervention Name(s)
serum saline
Intervention Description
50 ml of SS is given by IV root over 30 minutes
Intervention Type
Drug
Intervention Name(s)
Nebulised Serum Saline
Other Intervention Name(s)
serum saline
Intervention Description
3 nebulisations of 5ml SS each are given over 30 minutes
Primary Outcome Measure Information:
Title
efficacity: VAS pain reduction
Description
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.
Time Frame
5, 15, 30, 45 and 60 minutes
Secondary Outcome Measure Information:
Title
feasibility of the study: number of patients accepting the adhesion to protocol
Description
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).
Time Frame
at base line and at 60 minutes
Title
safety: side effects of treatment
Description
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.
Time Frame
5, 15, 30, 45 and 60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nouira Semir, Professor
Organizational Affiliation
University of Monastir
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of Fattouma Bourguiba
City
Monastir
ZIP/Postal Code
5000
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.urgencemonastir.com
Description
official department site
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IV NSAI Versus Nebulized Morphine Analgesia for First-line Renal Colic
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