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
Overview
- Phase
- Not Applicable
- Intervention
- IV titrated morphine
- Conditions
- Post-Traumatic Headache
- Sponsor
- University of Monastir
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Pain resolution
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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
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.
Investigators
Nouira
Professor
University of Monastir
Eligibility 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
- •nasal obstruction
- •allergy to opioids
Arms & Interventions
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.
Intervention: IV titrated morphine
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
Intervention: Low dose nebulised morphine
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.
Intervention: High dose nebulised morphine
Outcomes
Primary Outcomes
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 Outcomes
- side effects(30 minutes)