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

Acute Pain Clinical Trial

— TIMORNEB  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02200185
• Other study ID #: TIMORNEB
• Status: Completed
• Phase: N/A
• First received: July 22, 2014
• Last updated: November 26, 2014
• Start date: April 2012
• Est. completion date: July 2014

Study information

• Verified date: November 2014
• Source: University of Monastir
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Office of Pharmacies and Medicines
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pain
• Post-Traumatic Headache

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Tunisia	Emergency Department	Monastir

Sponsors (1)

Lead Sponsor	Collaborator
University of Monastir

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 minutes	Yes
Secondary	side effects	secondary outcomes combine the occurrence of side effects requiring discontinuation of treatment such as: dizziness, dyspnea, cutaneous rush, vomiting, nausea and pruritus.	30 minutes	Yes

External Links

•   official department site