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

N/ACompletedNCT02200185

University of Monastir300 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Post-Traumatic Headache Acute Pain

Interventions

IV titrated morphineDRUG

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

Low dose nebulised morphineDRUG

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

High dose nebulised morphineDRUG

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

Eligibility

Sex: ALLMin age: 8 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Emergency Department

Monastir, Monastir Governorate, Tunisia

Outcomes

Primary Outcomes

Pain resolution

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

Time frame: 30 minutes

Secondary Outcomes

side effects

secondary outcomes combine the occurrence of side effects requiring discontinuation of treatment such as: dizziness, dyspnea, cutaneous rush, vomiting, nausea and pruritus.

Time frame: 30 minutes

Data from ClinicalTrials.gov

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