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Nebulized Morphine in Chest Trauma Patients: A Prospective Study

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ClinicalTrials.gov Identifier: NCT03580187
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Majdoub Ali MD, University Hospital, Mahdia

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
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
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


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 (-)




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580187


Locations
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Tunisia
Mahdia Hospital Recruiting
Mahdia, Tunisia, 5180
Contact: ali majdoub, MD    50030022 ext +216    majdlee2005@yahoo.fr   
Sponsors and Collaborators
University Hospital, Mahdia

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Responsible Party: Majdoub Ali MD, head of anesthesia departement, University Hospital, Mahdia
ClinicalTrials.gov Identifier: NCT03580187     History of Changes
Other Study ID Numbers: NMCT/1
First Posted: July 9, 2018    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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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