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

July 22, 2014 updated by: Nouira, University of Monastir

Nebulized Morphine Versus Intravenous Morphine in the Management of Post Traumatic Pain in Emergency Department (ED)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
      • Monastir, Tunisia, 5000
        • Fattouma Bourguiba University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: 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%).
Active Comparator: 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%).
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%).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Resolution rate
Time Frame: one hour
resolution is defined as VAPS <30%.
one hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of side effects
Time Frame: one hour
Dyspnea, cutaneous rush, vomiting, nausea, pruritus and dizziness.
one hour
Resolution time
Time Frame: 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%
one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Monastir

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

May 11, 2010

First Submitted That Met QC Criteria

May 13, 2010

First Posted (Estimate)

May 14, 2010

Study Record Updates

Last Update Posted (Estimate)

July 23, 2014

Last Update Submitted That Met QC Criteria

July 22, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Morphine

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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