NCT01123551

Efficacy Study of Nebulized Morphine and Intravenous Morphine in Post Traumatic Pain

Nebulized Morphine Versus Intravenous Morphine in the Management of Post Traumatic Pain in Emergency Department (ED)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of Monastir · Academic / Other
• Sex: All
• Age: 8 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

In the emergency department, 60% of patients have an acute pain. Appropriate management of acute pain is a public health priority according to who recommendations. Nebulized morphine has been extensively studied in children but less well in adults. It offers a non-invasive route for systemic drug delivery, more rapid and less invasive than intravenous (IV) method.

Conditions

• Post Traumatic Pain

Interventions

Type	Name	Description
DRUG	nebulized morphine	After randomization, patients will receive 10 mg of morphine (1ml) diluted in 4 ml normal saline and nebulized with 6 l/mn during 10 min. Nebulization will be repeated systematically 3 times every twenty minutes unless the patient pain was resolved (VAPS 30%). In addition, patients receive a bolus of IV placebo(5 ml normal saline . IV placebo (2 ml) will be repeated every 10 minutes if the objective of analgesia was not reached .
DRUG	Intravenous morphine	After randomization, patients will receive a bolus of 5 mg of IV morphine (5 ml. Then, 2mg of IV morphine (2ml) will be added every 10 minutes if the objective of analgesia was not reached (VAPS \>30%). In addition, normal saline (5ml)is nebulized with 6 l/mn during 10 min and will be repeated systematically every 20 minutes unless the patient's pain was not resolved (VAPS \>30%).

Timeline

• Start date: 2010-06-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2010-05-14
• Last updated: 2014-07-23

Locations

1 site across 1 country: Tunisia