Titrated Versus High and Low Dose Nebulized Morphine to Reduce Pain in Emergency Settings (TIMORNEB)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02200185|
Recruitment Status : Completed
First Posted : July 25, 2014
Last Update Posted : December 2, 2014
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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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:
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
- 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
- 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.
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
|Monastir, Tunisia, 5000|
|Principal Investigator:||Nouira Semir, Professor||University of Monastir|