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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

Tracking Information
First Submitted Date  ICMJE June 14, 2018
First Posted Date  ICMJE July 9, 2018
Last Update Posted Date June 25, 2019
Actual Study Start Date  ICMJE January 10, 2014
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2018)
analgesia evaluated with visual scale [ Time Frame: 30 minuts ]
morphine (+) group: good response to morphine in nebulization morphine (-) group: failure of morphine in nebulization
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03580187 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nebulized Morphine in Chest Trauma Patients: A Prospective Study
Official Title  ICMJE Nebulized Morphine in Chest Trauma Patients: A Prospective Study
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Blunt Injury of Thorax
Intervention  ICMJE 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 (-)
Study Arms  ICMJE 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 (-)

Intervention: Drug: Morphine (+)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 2, 2018)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2019
Estimated Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Tunisia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03580187
Other Study ID Numbers  ICMJE NMCT/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Majdoub Ali MD, University Hospital, Mahdia
Study Sponsor  ICMJE University Hospital, Mahdia
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital, Mahdia
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP