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

Post Traumatic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123551
• Other study ID #: Morphine
• Status: Completed
• Phase: Phase 3
• First received: May 11, 2010
• Last updated: July 22, 2014
• Start date: June 2010
• Est. completion date: July 2014

Study information

• Verified date: July 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 50 Years

Eligibility

Inclusion Criteria:

• Post-traumatic pain with visual analog pain scale( VAPS) = 50%

• Age between 8 and 50 years.

Exclusion Criteria:

• Glasgow coma scale (GCS)< 14,

• Severe injury ,

• Hypotension : blood systolic pressure < 90 mmhg,

• Bradypnea < 12 cpm or SaO2< 90%,

• Chronic pain treatment,

• Aspirin or paracetamol treatment within 6 hours of emergency presentation,

• Nasal trauma, rhinitis, nasal obstruction,

• Incapacity to cooperate,

• Opiate allergy,

• Drug addiction,

• Pregnancy, breast feeding,

• Severe renal and liver failure and chronic obstructive pulmonary disease(COPD)

Study Design

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

Related Conditions & MeSH terms

• Post Traumatic Pain

Intervention

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 .
• 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%).

Locations

Country	Name	City	State
Tunisia	Fattouma Bourguiba University Hospital	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	1. Resolution rate	resolution is defined as VAPS <30%.	one hour	No
Secondary	rate of side effects	Dyspnea, cutaneous rush, vomiting, nausea, pruritus and dizziness.	one hour	Yes
Secondary	Resolution time	Resolution time is defined as the time between the starting of the protocol and pain decrease to a Visual Analog Scale less than 30%	one hour	No