Nebulized Morphine in Chest Trauma Patients: A Prospective Study
Primary Purpose
Blunt Injury of Thorax
Status
Completed
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
Morphine (+)
Sponsored by
About this trial
This is an interventional treatment trial for Blunt Injury of Thorax
Eligibility 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
Sites / Locations
- Mahdia Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
morphine +
Arm Description
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 (-)
Outcomes
Primary Outcome Measures
analgesia evaluated with visual scale
morphine (+) group: good response to morphine in nebulization morphine (-) group: failure of morphine in nebulization
Secondary Outcome Measures
Full Information
NCT ID
NCT03580187
First Posted
June 14, 2018
Last Updated
September 21, 2022
Sponsor
University Hospital, Mahdia
1. Study Identification
Unique Protocol Identification Number
NCT03580187
Brief Title
Nebulized Morphine in Chest Trauma Patients: A Prospective Study
Official Title
Nebulized Morphine in Chest Trauma Patients: A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
June 14, 2018 (Actual)
Primary Completion Date
April 15, 2020 (Actual)
Study Completion Date
April 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Mahdia
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blunt Injury of Thorax
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
morphine +
Arm Type
Other
Arm Description
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 Type
Drug
Intervention Name(s)
Morphine (+)
Other Intervention Name(s)
morphine (-)
Intervention Description
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
Primary Outcome Measure Information:
Title
analgesia evaluated with visual scale
Description
morphine (+) group: good response to morphine in nebulization morphine (-) group: failure of morphine in nebulization
Time Frame
30 minuts
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Mahdia Hospital
City
Mahdia
ZIP/Postal Code
5180
Country
Tunisia
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36196899
Citation
Attia H, Ben Saad H, Masmoudi K, Bannour I, Ouaz M, Gardabbou K, Majdoub A. Predictive factors of nebulized morphine failure in North-African patients with chest trauma: a prospective pilot study. Expert Rev Respir Med. 2022 Oct;16(10):1085-1092. doi: 10.1080/17476348.2022.2131543. Epub 2022 Oct 5.
Results Reference
derived
Learn more about this trial
Nebulized Morphine in Chest Trauma Patients: A Prospective Study
We'll reach out to this number within 24 hrs