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CompletedNCT03580187Updated Sep 23, 2022

Nebulized Morphine in Chest Trauma Patients: A Prospective Study

A Phase 3 interventional study of Morphine (+) in Blunt Injury of Thorax, sponsored by University Hospital, Mahdia. Completed at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-23.

Sponsored by University Hospital, Mahdia · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Blunt Injury of Thorax

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03

In context

Wounds, Nonpenetrating

37 studies on the registry are indexed under Wounds, Nonpenetrating; 11 are open to participants now.

This study's enrollment of 75 is below the median of 120 across 15 interventional studies indexed under Wounds, Nonpenetrating.

Browse Wounds, Nonpenetrating studies →

Lead sponsor

University Hospital, Mahdia is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients aged 18 years and over
  • victims of isolated chest trauma,
  • admitted to the intensive care unit

Exclusion criteria

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (actual)

Study arms

  • Other
    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 (+)

Interventions

  • DrugMorphine (+)

    Drug page: 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

    Also known as: morphine (-)

06

What researchers measure

Primary outcomes

  1. analgesia evaluated with visual scale

    morphine (+) group: good response to morphine in nebulization morphine (-) group: failure of morphine in nebulization

    Time frame: 30 minuts

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Study locations

1 site
  • Mahdia Hospital
    Mahdia, 5180, Tunisia
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References and documents

Publications

  • 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. PubMed 36196899 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2018 to primary completion in Apr 2020, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 14, 2018
First posted
Jul 9, 2018
StartActual
Jun 14, 2018
Primary completionActual
Apr 15, 2020
CompletionActual
Apr 15, 2020
Last update
Sep 23, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03580187
Lead sponsor
University Hospital, Mahdia
Responsible party
Majdoub Ali MD (head of anesthesia departement, University Hospital, Mahdia) — Principal investigator
First posted
Jul 9, 2018
Start date
Jun 14, 2018
Primary completion
Apr 15, 2020
Completion
Apr 15, 2020
Last update
Sep 23, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Morphine

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Wounds, Nonpenetrating →

Other studies from this sponsor

University Hospital, Mahdia

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