Nebulized Morphine in Chest Trauma Patients: A Prospective Study

Blunt Injury of Thorax Clinical Trial

Official title:

Nebulized Morphine in Chest Trauma Patients: A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03580187
• Other study ID #: NMCT/1
• Status: Completed
• Phase: Phase 3
• Start date: June 14, 2018
• Est. completion date: April 15, 2020

Study information

• Verified date: September 2022
• Source: University Hospital, Mahdia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blunt Injury of Thorax
• Thoracic Injuries
• Wounds, Nonpenetrating

Intervention

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

Locations

Country	Name	City	State
Tunisia	Mahdia Hospital	Mahdia

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Mahdia

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	analgesia evaluated with visual scale	morphine (+) group: good response to morphine in nebulization morphine (-) group: failure of morphine in nebulization	30 minuts