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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Post Traumatic Pain

Intervention / Treatment
-----------------
* Drug: nebulized morphine
* Drug: Intravenous morphine


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nebulized Morphine<br>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: nebulized morphine<br>* 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 .<br>Drug: Intravenous morphine<br>* 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%).<br>|
| Active Comparator: Intravenous morphine<br>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%). | Drug: Intravenous morphine<br>* 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%).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Resolution rate | resolution is defined as VAPS <30%. | one hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of side effects | Dyspnea, cutaneous rush, vomiting, nausea, pruritus and dizziness. | one hour | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nebulized morphine, Intravenous morphine, Post traumatic, Pain, Emergency department