Clinical trial NCT03580187: Nebulized Morphine in Chest Trauma Patients: A Prospective Study
Official title: Nebulized Morphine in Chest Trauma Patients: A Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Blunt Injury of Thorax
Lead sponsor: University Hospital, Mahdia
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: analgesia evaluated with visual scale
timeFrame: 30 minuts
Secondary outcomes:
Other outcomes:
Locations:
city: Mahdia
country: Tunisia
facility: Mahdia Hospital
Study officials:
References:
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.