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Completed

NCT Number: NCT00237731

Pre-hospital Morphine Titration : Comparison of 0,05 Versus 0,1 mg/kg

Efficacy and safety of morphine titration on acute pain in emergency medical mobile units with initial bolus of 0.1 mg/kg plus 0.05 mg/kg versus morphine titration with initial bolus of 0.05 mg/kg plus 0.025 mg/kg

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Key information

Conditions

Severe, Acute Pain in a Pre-hospital Setting Acute Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

SAMU 31 Hôpital PURPAN

Toulouse, 31059, France

About this study

STUDY OBJECTIVE : Assess the efficacy of a morphine dose of 0.1 mg/kg versus a morphine dose of 0.05 mg/kg in pre-hospital pain METHODS : Consecutive patients with severe, acute pain defined as a verbal rating scale (VRS) of 60/100 or higher may be included. 106 patients at all are required in the study. They will be randomised in two groups : group A will receive an initial intravenous injection of 0.05 mg/kg then injections of 0.025 mg/kg every 5 minutes and group B will receive an initial intravenous injection 0.1 mg/kg then injections of 0.05 mg/kg every 5 minutes. The pain scale will be checked every 5 minutes during 30 minutes. The titration will be stopped before, if the VRS is < or = 30. The patient will be followed during the study until 60 minutes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Severe, acute pain defined by a VRS of 60/100 or higher
  • Male or female over 18 years
  • Cared by a medical emergency care unit
  • Written informed consent
  • Affiliated to social security

Exclusion criteria

  • A known opioid or paracetamol hypersensitivity
  • Patient not agree ta participate at the study
  • Pregnancy
  • Uncontrolled epilepsia
  • Incapacity to understand the VRS
  • Renal, respiratory, or liver disease
  • Patients who have received sedative drugs or alcohol (< 6h)
  • Acute respiratory, haemodynamic or neurologic failure
  • Patients who have already received an analgesic (< 6h)
  • Drug addiction
  • Patients under protection of justice

Treatment and study plan

Morphine

Drug

morphine 0.05

Primary outcomes

  1. A verbal rating scale of 30/100 or lower measured 30 minutes after initial administration

Secondary outcomes

  1. Time to obtain an analgesia, defined by a VRS < or = 30

  2. Patients' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)

  3. Investigators' satisfaction with analgesia (pain relief classified as excellent, good, mild or weak)

  4. Safety evaluation

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Oct 12, 2005
Registry last updated
May 12, 2017

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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