Post Traumatic Pain
Conditions
Keywords
Nebulized morphine, Intravenous morphine, Post traumatic, Pain, Emergency department
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.
Interventions
DRUGnebulized 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 .
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%).
Sponsors
University of Monastir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 50 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Resolution rate | one hour | resolution is defined as VAPS \<30%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of side effects | one hour | Dyspnea, cutaneous rush, vomiting, nausea, pruritus and dizziness. |
| Resolution time | one hour | Resolution time is defined as the time between the starting of the protocol and pain decrease to a Visual Analog Scale less than 30% |
Countries
Tunisia
Outcome results
None listed