Nebulized Morphine in Chest Trauma Patients: A Prospective Study

NCT03580187 | Completed Phase 3

• 1 other identifier: NMCT/1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Blunt Injury of Thorax

Outcome Measures

Primary Outcomes (1)

• analgesia evaluated with visual scale

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

  30 minuts

Study Arms (1)

morphine +

OTHER

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 (-)

Drug: Morphine (+)

Interventions

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

Also known as: morphine (-)

morphine +

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Mahdia: lead

Study Sites (1)

Mahdia Hospital

Mahdia, 5180, Tunisia

Location

Related Publications (1)

• Attia H, Ben Saad H, Masmoudi K, Bannour I, Ouaz M, Gardabbou K, Majdoub A. Predictive factors of nebulized morphine failure in North-African patients with chest trauma: a prospective pilot study. Expert Rev Respir Med. 2022 Oct;16(10):1085-1092. doi: 10.1080/17476348.2022.2131543. Epub 2022 Oct 5.

  PMID: 36196899 DERIVED

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of anesthesia departement

Model Details: 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

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 9, 2018
• Study Start: June 14, 2018
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: September 23, 2022

Record last verified: 2022-09

Locations

TU (1)