Nebulized Morphine in Chest Trauma Patients: A Prospective Study

Phase 3

Completed

• Conditions: Blunt Injury of Thorax
• Interventions: Drug: Morphine (+)

• Registration Number: NCT03580187
• Lead Sponsor: University Hospital, Mahdia

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.

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 Timeline

• Study Start: 2018-06-14
• Study First Submitted: 2018-06-14
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-09
• Primary Completion: 2020-04-15
• Study Completion: 2020-04-15
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-21
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
morphine +	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 (-)

Primary Outcome Measures

Name	Time	Method
analgesia evaluated with visual scale	30 minuts	morphine (+) group: good response to morphine in nebulization morphine (-) group: failure of morphine in nebulization

Trial Locations

Locations (1)

Mahdia Hospital; 🇹🇳 Mahdia, Tunisia