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Titrated Versus High and Low Dose Nebulized Morphine to Reduce Pain in Emergency Settings (TIMORNEB)

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ClinicalTrials.gov Identifier: NCT02200185
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Nouira, University of Monastir

Brief Summary:

The investigators test a different technique using morphine to improve pain relief in patient visiting the emergency department with acute trauma pain, for this we are comparing three different methods of morphine administration:

  • intravenous titrated morphine
  • low dose nebulized morphine and
  • high dose nebulized morphine

Condition or disease Intervention/treatment Phase
Post-Traumatic Headache Acute Pain Drug: IV titrated morphine Drug: Low dose nebulised morphine Drug: High dose nebulised morphine Not Applicable

Detailed Description:

Trauma patients are frequent in emergency department settings, and often require urgent care.

taking care of this patients consists on taking care of their pain and then the specific treatment of their traumatic lesions.

actually, the most used medicine and most efficient one in treating pain is morphine, it's mechanism of action is by acting on receptors located on neuronal cell membranes and inhibit neurotransmitter release.

The most applied administration root of morphine is by intravenous (IV) titration or IV continuous perfusion, but until now, there is no clear recommendation concerning the superiority of this root over other administration techniques such as nebulization.

In this study we aimed to investigate the efficiency, the feasibility and the tolerance of three morphine administration roots in patients with acute traumatic pain and to clarify the most adequate one to apply in emergency department settings.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Nebulized Morphine Given at Two Different Doses Compared to Intravenous Morphine in Post-traumatic Acute Pain: a Randomized Controlled Double Blind Study
Study Start Date : April 2012
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: IV titrated morphine

patient will receive 2 mg morphine each 5 min, associated to continuous nebulisation of saline serum (placebo).

Morphine administration is stopped when VAS becomes under 50% and treatment failure is defined as VAS > 50%, 30 minutes after the beginning of the protocol.

Drug: IV titrated morphine

Intravenous morphine : 2 mg every 5 minutes by IV root and nebulized placebo:

  • SS nebulised : 5 ml SS nebulised over 10 minutes and repeated 3 times
Other Name: IV morphine group

Experimental: Low dose nebulised morphine

patient will receive 10 mg of morphine prepared with 4 ml saline serum (SS) and nebulised with 6 l/min flow during 10 minutes.

Nebulisation will be repeated 3 times, in addition, patients receive 2 ml IV SS every 5 minutes as placebo

Drug: Low dose nebulised morphine
10 mg morphine in 4 ml Serum Saline(SS) nebulised over 10 minutes and repeated 3 times, and SS IV placebo : 2 ml by IV root every 5 minutes
Other Name: Neb10

Experimental: High dose nebulised morphine

patient will receive 20 mg of morphine prepared with 3 ml saline serum (SS) and nebulised with 6 l/min flow during 10 minutes.

Nebulisation will be repeated 3 times, in addition, patients receive 2 ml IV SS every 5 minutes as placebo.

Drug: High dose nebulised morphine
20 mg morphine in 3 ml serum saline (SS) nebulised over 10 minutes and repeated 3 times, and SS IV placebo : 2 ml by IV root every 5 minutes
Other Name: Neb20




Primary Outcome Measures :
  1. Pain resolution [ Time Frame: 30 minutes ]
    primary end point defined by the decrease in intensity pain objectified by a decline in visual analogy pain scale greater than or equal to 50% of its initial value


Secondary Outcome Measures :
  1. side effects [ Time Frame: 30 minutes ]
    secondary outcomes combine the occurrence of side effects requiring discontinuation of treatment such as: dizziness, dyspnea, cutaneous rush, vomiting, nausea and pruritus.



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Ages Eligible for Study:   8 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients older than 8 years and less than 50 years
  • patients who consult emergency department for sever pain after an immediately trauma

Exclusion Criteria:

  • Glasgow coma scale <14
  • inability to cooperate
  • hypotension with systolic blood pressure< 90mmhg
  • bradypnea<12cpm
  • SAO2<90%
  • polytrauma
  • nasal trauma
  • rhinitis
  • nasal obstruction
  • allergy to opioids

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): NCT02200185


Locations
Tunisia
Emergency Department
Monastir, Tunisia, 5000
Sponsors and Collaborators
University of Monastir
Investigators
Principal Investigator: Nouira Semir, Professor University of Monastir

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nouira, Professor, University of Monastir
ClinicalTrials.gov Identifier: NCT02200185     History of Changes
Other Study ID Numbers: TIMORNEB
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Nouira, University of Monastir:
post traumatic pain
titrated morphine
nebulised morphine

Additional relevant MeSH terms:
Headache
Acute Pain
Post-Traumatic Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents