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

Phase 3

Completed

• Conditions: Post Traumatic Pain
• Interventions: Drug: nebulized morphine; Drug: Intravenous morphine

• Registration Number: NCT01123551
• Lead Sponsor: University of Monastir

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-13
• Study First Posted: 2010-05-14
• Study Start: 2010-06
• Status Verified: 2014-07
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-22
• Last Update Posted: 2014-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nebulized Morphine	Intravenous 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 .
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 .
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%).

Primary Outcome Measures

Name	Time	Method
1. Resolution rate	one hour	resolution is defined as VAPS \<30%.

Secondary Outcome Measures

Name	Time	Method
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%
rate of side effects	one hour	Dyspnea, cutaneous rush, vomiting, nausea, pruritus and dizziness.

Trial Locations

Locations (1)

Fattouma Bourguiba University Hospital; 🇹🇳 Monastir, Tunisia