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Related Experiment Videos

Rescue factor: a design for evaluating long-acting analgesics.

J J Savarese1, G B Thomas, H Homesley

  • 1Medical Department, Purdue Frederick Company, Norwalk, Conn.

Clinical Pharmacology and Therapeutics
|April 1, 1988
PubMed
Summary

This study introduces a novel method for evaluating pain relievers by measuring the need for supplemental analgesics. Long-acting oral morphine sulfate (MS Contin) proved more effective than immediate-release morphine for cancer pain relief.

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Area of Science:

  • Pharmacology
  • Clinical Trial Design
  • Pain Management

Background:

  • Evaluating analgesic effectiveness, especially for long-acting formulations, requires robust methodologies.
  • Supplemental (rescue) analgesic use is a key indicator of a primary analgesic's efficacy.

Purpose of the Study:

  • To introduce and validate a study design that uses rescue analgesic need to predict test analgesic effectiveness.
  • To compare the efficacy of oral long-acting morphine sulfate (MS Contin) with immediate-release oral morphine sulfate in cancer pain patients.

Main Methods:

  • A crossover study design was employed, titrating doses to minimize rescue analgesic requirements.
  • Cancer pain patients received either MS Contin every 12 hours or immediate-release morphine sulfate every 4 hours.

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  • Rescue analgesic use was meticulously recorded over dosing intervals.

    • Main Results:

    • Patients required significantly less total morphine with MS Contin (186 +/- 22 mg) compared to immediate-release morphine (239 +/- 35 mg; p = 0.04).
    • Total daily morphine consumption for both regimens showed a strong linear correlation (r = 0.96), with a slope significantly favoring MS Contin (1.27 +/- 0.11; p = 0.03).

    Conclusions:

    • The described study design is sensitive to dose-response and provides reliable relative potency estimates for analgesics.
    • Oral long-acting morphine sulfate (MS Contin) offers a more effective and potentially lower-dose regimen for managing cancer pain compared to frequent immediate-release morphine administration.