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.

Study Overview

• Status: Completed
• Conditions: Blunt Injury of Thorax
• Intervention / Treatment: Drug: Morphine (+)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 3

Contacts and Locations

Study Locations

• Tunisia
  • Mahdia, Tunisia, 5180
    • Mahdia Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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 (-)

Drug: 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; Other Names: morphine (-)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
analgesia evaluated with visual scale	morphine (+) group: good response to morphine in nebulization morphine (-) group: failure of morphine in nebulization	30 minuts

Collaborators and Investigators

• Sponsor: University Hospital, Mahdia

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2018
• Primary Completion (Actual): April 15, 2020
• Study Completion (Actual): April 15, 2020

Study Registration Dates

• First Submitted: June 14, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 9, 2018

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: September 21, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Thoracic Injuries; Wounds, Nonpenetrating; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Morphine
• Other Study ID Numbers: NMCT/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No