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

Sponsor

University of Monastir (Other)

Overall Status

Completed

CT.gov ID

NCT02200185

Collaborator

(none)

300

Enrollment

Location

Arms

Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Apr 1, 2012

Actual Primary Completion Date :

Jul 1, 2014

Actual Study Completion Date :

Jul 1, 2014

Arms and Interventions

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 Names: 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 Names: 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 Names: Neb20

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 Names:

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 Names:

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 Names:

Neb20

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.