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Completed

NCT Number: NCT01123551

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

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.

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Key information

Conditions

Post Traumatic Pain Disease Attributes Emergencies Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fattouma Bourguiba University Hospital

Monastir, Monastir Governorate, 5000, Tunisia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

nebulized morphine

Drug

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

Drug

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 outcomes

  1. 1. Resolution rate

    Time frame: one hour

    resolution is defined as VAPS <30%.

Secondary outcomes

  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%

Sponsors and collaborators

Lead sponsor

University of Monastir

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 14, 2010
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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