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

University of Monastir

Status and phase: Completed; Phase 3

Conditions: Post Traumatic Pain

Treatments: Drug: nebulized morphine; Drug: Intravenous morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT01123551

Morphine

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 8 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Nebulized Morphine

Experimental group

Description:

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 .

Treatment:

Drug: nebulized morphine

Drug: Intravenous morphine

Intravenous morphine

Active Comparator group

Description:

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%).

Treatment:

Drug: Intravenous morphine