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Completed

NCT Number: NCT03580187

Nebulized Morphine in Chest Trauma Patients: A Prospective Study

This is a prospective study carried out from 2018 to 2020 including patients aged ≥ 18 years, admitted for isolated chest trauma. Each patient received a nebulization of 10 mg morphine. If Visual Analog Score (VAS) assessed after 10 minutes still> 4, nebulization was repeated every 10 minutes until pain relief. At 30 minutes, VAS> 4 means failure.

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Key information

Conditions

Blunt Injury of Thorax

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mahdia Hospital

Mahdia, 5180, Tunisia

About this study

The aim of this study was to determine the predictive factors of nebulized morphine failure in patients with chest trauma and to establish a score based on these factors to guide the analgesic protocol.

Methods: This is a prospective study carried out from 2018 to 2020 including patients aged ≥ 18 years, admitted for isolated chest trauma. Each patient received a nebulization of 10 mg morphine. If Visual Analog Score (VAS) assessed after 10 minutes still> 4, nebulization was repeated every 10 minutes until pain relief. At 30 minutes, VAS> 4 means failure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients aged 18 years and over
  • victims of isolated chest trauma,
  • admitted to the intensive care unit

Exclusion criteria

  • not consen
  • pregnant woman
  • polytrauma
  • hemodynamic instability with systolic blood pressure less than 100 mmHg,
  • treated with morphine during transport or in the emergency room
  • need initial ventilatory support, bradypnea (respiratory rate less than 12 cycles per minute)
  • allergy to opiods
  • initial pain Visual Analog Scale (VAS) ≤ 4

Treatment and study plan

Morphine (+)

Drug

We performed a first nebulization of 10 mg (1mL) of morphine diluted in 4 mL of normal saline using a nebulizer with an oxygen flow rate of 8 L / min. The quality of analgesia was assessed by VAS at rest and cough after 10 minutes. If ≤ 4, we concluded to a success. If VAS was still> 4, a second nebulization was performed. After 20 minutes, if VAS still higher than 4 we performed a third nebulization. If pain level was ≤ 4, we concluded to a success. After 30 minutes, if VAS still> 4, we concluded to a failure of morphine nebulization.

The patients were divided into two groups:

morphine (+) group: good response to morphine in nebulization morphine (-) group: failure of morphine in nebulization

Other names: morphine (-)

Primary outcomes

  1. analgesia evaluated with visual scale

    Time frame: 30 minuts

    morphine (+) group: good response to morphine in nebulization morphine (-) group: failure of morphine in nebulization

Sponsors and collaborators

Lead sponsor

University Hospital, Mahdia

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 9, 2018
Registry last updated
Sep 23, 2022

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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