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

Not Applicable

Completed

• Conditions: Acute Pain; Post-Traumatic Headache
• Interventions: Drug: High dose nebulised morphine; Drug: Low dose nebulised morphine; Drug: IV titrated morphine

• Registration Number: NCT02200185
• Lead Sponsor: University of Monastir

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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-26
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High 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.
Low dose nebulised 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
IV titrated morphine	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Emergency Department; 🇹🇳 Monastir, Tunisia