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

NCT01123551 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2014-07-23

No results posted yet for this study

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.

Conditions

  • Post Traumatic Pain

Interventions

DRUG

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 .

DRUG

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%).

Sponsors & Collaborators

  • University of Monastir

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Tunisia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01123551 on ClinicalTrials.gov