Nebulized Morphine in Chest Trauma Patients: A Prospective Study

• ClinicalTrials.gov Identifier: NCT03580187
• Recruitment Status: Completed
• First Posted: July 9, 2018
• Last Update Posted: April 16, 2020
• Sponsor: University Hospital, Mahdia
• Information provided by (Responsible Party): Majdoub Ali MD, University Hospital, Mahdia

Study Description

Brief Summary:

This is a prospective study carried out from 2014 to 2016 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.

Condition or disease	Intervention/treatment	Phase
Blunt Injury of Thorax	Drug: Morphine (+)	Phase 3

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 2014 to 2016 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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 75 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: 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
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Nebulized Morphine in Chest Trauma Patients: A Prospective Study
• Actual Study Start Date: January 10, 2014
• Actual Primary Completion Date: June 30, 2019
• Actual Study Completion Date: December 30, 2019

Arms and Interventions

Arm

Intervention/treatment

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 Name: morphine (-)

Outcome Measures

Primary Outcome Measures :

1. analgesia evaluated with visual scale [ Time Frame: 30 minuts ]
   morphine (+) group: good response to morphine in nebulization morphine (-) group: failure of morphine in nebulization

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Tunisia

Mahdia Hospital

Mahdia, Tunisia, 5180

Sponsors and Collaborators

University Hospital, Mahdia

More Information

• Responsible Party: Majdoub Ali MD, head of anesthesia departement, University Hospital, Mahdia
• ClinicalTrials.gov Identifier: NCT03580187
• Other Study ID Numbers: NMCT/1
• First Posted: July 9, 2018
• Last Update Posted: April 16, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Additional relevant MeSH terms:

Thoracic Injuries; Wounds, Nonpenetrating; Wounds and Injuries; Morphine; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics; Sensory System Agents; Peripheral Nervous System Agents