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

Sponsor
University of Monastir (Other)
Overall Status
Completed
CT.gov ID
NCT02156596
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
60
Duration (Months)
1.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: IV NSAI
  • Drug: NM
  • Drug: IV Serum Saline
  • Drug: Nebulised Serum Saline
 Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
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 Start Date :
Feb 1, 2013
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Feb 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Intravenous NSAI

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
100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root
Other Names:
  • ketoprofen IV

    • Drug: Nebulised Serum Saline
    3 nebulisations of 5ml SS each are given over 30 minutes
    Other Names:
  • serum saline

    		•
    Experimental: Nebulised Morphine

    patients received 3 nebulisation of morphine (5 mg each) and in parallel 50 ml of SS by IV root over 30 minutes.

    Drug: NM
    3 nebulisations of 5 mg morphine chlorhydrate each given over 30 minutes (10 minutes per nebulisation)
    Other Names:
  • morphine

    • Drug: IV Serum Saline
    50 ml of SS is given by IV root over 30 minutes
    Other Names:
  • serum saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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).

    2. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital of Fattouma Bourguiba Monastir Tunisia 5000

    Sponsors and Collaborators

    • University of Monastir

    Investigators

    • Principal Investigator: Nouira Semir, Professor, University of Monastir

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pr. Semir Nouira, Clinical Professor, University of Monastir
    ClinicalTrials.gov Identifier:
    NCT02156596
    Other Study ID Numbers:
    • NSAI vs Morphine
    First Posted:
    Jun 5, 2014
    Last Update Posted:
    Feb 11, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Pr. Semir Nouira, Clinical Professor, University of Monastir
    renal colic
    nebulised morphine
    Intravenous NSAID
    Additional relevant MeSH terms:
    Colic
    Renal Colic
    Ketoprofen
    Morphine

    Study Results

    No Results Posted as of Feb 11, 2020