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Completed

NCT Number: NCT02200185

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

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

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Key information

Conditions

Post-Traumatic Headache Acute Pain Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Secondary Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emergency Department

Monastir, Monastir Governorate, 5000, Tunisia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IV titrated morphine

Drug

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

Low dose nebulised morphine

Drug

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

High dose nebulised morphine

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study 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

Acronym: TIMORNEB

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 25, 2014
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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