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

NCT ID: NCT02200185

Last Updated: 2014-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2014-07-31

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.

Conditions

Post-Traumatic Headache; Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

IV titrated morphine

Intervention Type: 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

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

Group Type: EXPERIMENTAL

Low dose nebulised morphine

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

High dose nebulised morphine

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

IV morphine group; Neb10; Neb20

Eligibility Criteria

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Monastir

OTHER

Sponsor Role: lead

Responsible Party

Nouira

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nouira Semir, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Monastir

Locations

Emergency Department

Monastir, Monastir Governorate, Tunisia

Countries

Tunisia

References

Grissa MH, Boubaker H, Zorgati A, Beltaief K, Zhani W, Msolli MA, Bzeouich N, Bouida W, Boukef R, Nouira S. Efficacy and safety of nebulized morphine given at 2 different doses compared to IV titrated morphine in trauma pain. Am J Emerg Med. 2015 Nov;33(11):1557-61. doi: 10.1016/j.ajem.2015.06.014. Epub 2015 Jun 14.

Reference Type: DERIVED

PMID: 26143313 (View on PubMed)

Related Links

http://www.urgencemonastir.com

official department site

Other Identifiers

TIMORNEB

Identifier Type: -

Identifier Source: org_study_id