A Trial Comparing Different Dosing Regimens of Morphine in Patients With Moderate to Severe Pain
Condition: Pain
Study type: Interventional

Summary: 
      RESEARCH QUESTION: In adult ED patients in whom the attending ED physician has decided to
      administer intravenous opiates, what is the difference in pain relief at 60 minutes in
      patients who are randomized to receive either weight-based IV morphine 0.1mg/kg or
      weight-based IV morphine 0.15 mg/kg?

      HYPOTHESIS: In adult ED patients who receive IV morphine at a dose of 0.15/mg, more patients
      will report moderate to complete pain relief than patients receiving a dose of 0.1 mg/kg.

      SIGNIFICANCE: If it is shown that morphine 0.15 mg/kg gives better pain relief to patients
      with comparable side effects when compared with morphine at a dose of 0.1 mg/kg, then we may
      be able to provide evidence to suggest that the higher dose should be used for adult ED
      patients under the age of 66 presenting with acute pain.
    

Detailed description: 
      RESEARCH QUESTION: In adult ED patients in whom the attending ED physician has decided to
      administer intravenous opiates, what is the between-group difference in before-after
      improvement in pain relief at 60 minutes in patients who are randomized to receive either
      weight-based IV morphine 0.1mg/kg or weight-based IV morphine 0.15 mg/kg?

      HYPOTHESIS: In adult ED patients who receive IV morphine at a dose of 0.15/mg, more patients
      will report moderate to complete pain relief than patients receiving a dose of 0.1 mg/kg.

      SIGNIFICANCE: If it is shown that morphine 0.15 mg/kg gives better pain relief to patients
      with comparable side effects when compared with morphine at a dose of 0.1 mg/kg, then we may
      be able to provide evidence to suggest that the higher dose should be used for adult ED
      patients under the age of 66 presenting with acute pain.

      METHODS/DESIGN: Prospective, double blind, randomized clinical trial. Adult ED patients
      between the ages of 18 and 65 years of age in whom the attending ED physician has decided to
      administer parenteral opiates, will be randomized to receive either 0.1 mg/kg IV morphine
      (maximum dose of 10 mg) or 0.15mg/kg IV morphine (maximum dose of 15 mg). An on-line random
      plan generator (http://www.randomization.com) will be used to generate an allocation
      schedule. The allocation schedule will be fully documented with the reference citation of the
      pseudo-random number generator, the seed used to start the generation process, the number of
      treatments (2), the allocation ratio (1:1), the size and number of blocks, and a copy of the
      assignment list. The allocation schedule will be given to the Montefiore Department of
      Pharmacy where it will be used to determine the content of consecutively numbered vials with
      either the study doses of morphine. The Pharmacy Department will prepare and handle the vials
      in accordance with known stability data and labeled with expiration dates. They will provide
      the study with labeled packages containing the numbered vial, a label with the vial number to
      be attached to the patient's data collection instrument, an opaque envelope with the
      assignment group identified (to be used in the event of a clinical emergency that requires
      immediate determination of what the patient received) and a weight based dosing schedule for
      morphine. All patients will receive a bolus of morphine 0.1mg/kg at time 0. At 30 minutes,
      patients will receive the study drug which will contain either an additional 0.05mg/kg of
      morphine or placebo. After the initial morphine bolus and study drug, patients will have
      received either morphine 0.1 mg/kg (maximum of 10 mg) or 0.15 mg/kg (maximum of 15mg).
    

Intervention name(s): Morphine 0.1mg/kg versus morphine 0.15 mg/kg
Intervention type(s): Drug
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pain; Morphine