Acute Pain, Post-Traumatic Headache
Conditions
Keywords
post traumatic pain, titrated morphine, nebulised morphine
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.
Interventions
DRUGIV 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
DRUGLow 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
DRUGHigh 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
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
8 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain resolution | 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
| Measure | Time frame | Description |
|---|---|---|
| side effects | 30 minutes | secondary outcomes combine the occurrence of side effects requiring discontinuation of treatment such as: dizziness, dyspnea, cutaneous rush, vomiting, nausea and pruritus. |
Countries
Tunisia
Outcome results
None listed