Nebulized Morphine Versus Intravenous Morphine in the Management of Post Traumatic Pain in Emergency Department (ED)
Overview
- Phase
- Phase 3
- Intervention
- nebulized morphine
- Conditions
- Post Traumatic Pain
- Sponsor
- University of Monastir
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- 1. Resolution rate
- Status
- Completed
- Last Updated
- 11 years ago
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.
Investigators
Nouira
Professor
University of Monastir
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,
Arms & Interventions
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 .
Intervention: nebulized morphine
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 .
Intervention: Intravenous morphine
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%).
Intervention: Intravenous morphine
Outcomes
Primary Outcomes
1. Resolution rate
Time Frame: one hour
resolution is defined as VAPS \<30%.
Secondary Outcomes
- Resolution time(one hour)
- rate of side effects(one hour)