Nebulized Morphine in Chest Trauma Patients: A Prospective Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-14

Study Completion Date

2020-04-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Blunt Injury of Thorax

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Were included all patients aged 18 years and over, victims of isolated chest trauma, who were admitted to the intensive care unit. We excluded patients with any of the following criteria: not consent, pregnant woman, polytrauma, hemodynamic instability with systolic blood pressure less than 100 mmHg, treatment with morphine during transport or in the emergency room, need for initial ventilatory support, bradypnea (respiratory rate less than 12 cycles per minute), allergy to opiods, initial pain Visual Analog Scale (VAS) ≤ 4. Pain level was assessed by the pain VAS. We collected demographic, epidemiological, initial clinical examination data, explorations, lesions and we monitored the evolution of the VAS and the vital signs. Informed consent was obtained from all patients

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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morphine +

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.

morphine (+) group: good response to morphine in nebulization after 30 min if VAS \> than 4 we conclude to morhine (-)

Group Type OTHER

Morphine (+)

Intervention Type 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

Interventions

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Morphine (+)

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

Intervention Type DRUG

Other Intervention Names

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morphine (-)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No