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Completed

NCT Number: NCT02156596

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

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital of Fattouma Bourguiba

Monastir, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

IV NSAI

Drug

100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root

Other names: ketoprofen IV

NM

Drug

3 nebulisations of 5 mg morphine chlorhydrate each given over 30 minutes (10 minutes per nebulisation)

Other names: morphine

IV Serum Saline

Drug

50 ml of SS is given by IV root over 30 minutes

Other names: serum saline

Nebulised Serum Saline

Drug

3 nebulisations of 5ml SS each are given over 30 minutes

Other names: serum saline

Primary outcomes

  1. efficacity: VAS pain reduction

    Time frame: 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 outcomes

  1. feasibility of the study: number of patients accepting the adhesion to protocol

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study 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.

Acronym: NSAIvsNM

Important dates

Study start
2013
Primary completion
2017
Study completion
2018
First posted
Jun 5, 2014
Registry last updated
Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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