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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01123551
Recruitment Status : Completed
First Posted : May 14, 2010
Last Update Posted : July 23, 2014
Sponsor:
Information provided by (Responsible Party):
Nouira, 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.


Condition or disease Intervention/treatment Phase
Post Traumatic Pain Drug: nebulized morphine Drug: Intravenous morphine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nebulized Morphine Versus Intravenous Morphine in the Management of Post Traumatic Pain in Emergency Department (ED)
Study Start Date : June 2010
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine


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%).




Primary Outcome Measures :
  1. 1. Resolution rate [ Time Frame: one hour ]
    resolution is defined as VAPS <30%.


Secondary Outcome Measures :
  1. rate of side effects [ Time Frame: one hour ]
    Dyspnea, cutaneous rush, vomiting, nausea, pruritus and dizziness.

  2. 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%



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Ages Eligible for Study:   8 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01123551


Locations
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Tunisia
Fattouma Bourguiba University Hospital
Monastir, Tunisia, 5000
Sponsors and Collaborators
University of Monastir
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Responsible Party: Nouira, Professor, University of Monastir
ClinicalTrials.gov Identifier: NCT01123551    
Other Study ID Numbers: Morphine
First Posted: May 14, 2010    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: July 2014
Keywords provided by Nouira, University of Monastir:
Nebulized morphine
Intravenous morphine
Post traumatic
Pain
Emergency department
Additional relevant MeSH terms:
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Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents