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Trial Design: Pain Sections
Author Bio
Introduction
Placebo Effects
Single Dose Trials
Currently selected section: Repeated Dose Trials
Explanatory Versus Pragmatic
Dose-Response
Parallel Group Versus Crossover
Conclusion
 
Chapter 1: Clinical Trials of Pain Treatment: Repeated Dose Trials: Problem 4.2
 
       

How would we interpret the results?

You answered:


Selection B Without a positive control, one cannot distinguish lack of analgesic efficacy from lack of assay sensitivity.

CORRECT

It is possible that this "analgesic assay" would have been insensitive to even a powerful analgesic because of the choice of patients, the way pain was assessed, or other reasons. In order to assess assay sensitivity, one would add a positive control group such as a background morphine infusion, a larger standard PCA morphine bolus size than 3 mg, or a single strong analgesic treatment such as a large analgesic dose or a nerve block . The comparison of this treatment with the "placebo" (i.e. PCA morphine, 3 mg) group ( Figure 4.3b,c ) would reveal whether the assay was:


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Figure 4.3b: Value of Positive Control in a PCA Study

  • Sensitive enough to pick up the effects of this positive control (thus proving that the proglumide supplements were ineffective).
  • Insensitive to the effects of a known analgesic (and hence inconclusive regarding proglumide).
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