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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 4.1: Question 4.1.1
 
 

Does this result Drug K as an effective analgesic?

You answered:

Yes.
This result demonstrates that Drug K is an effective analgesic.


INCORRECT


Although one explanation of the results is that Drug K is an effective analgesic, allowing patients to decrease their use of supplementary morphine, there are other possibilities, particularly in view of the lack of any reduction in pain intensity. (It is possible that patients in the placebo group took enough extra morphine to reduce their pain to the level of the Drug K group, but patients rarely self-administer analgesics liberally enough to overcome such treatment differences.)

Alternative explanations may include:

  • Drug K made patients too sleepy to push the PCA button;
  • Drug K potentiates opioid-induced nausea and patients became so nauseated that they were afraid of taking morphine; and
  • Drug K made patients anxious and those who were fearful of opioids to begin with were even more reluctant to push the PCA button.

Another way of expressing this is to say that pain and pain relief are defined by the patient’s report, while the self-administration of analgesic is a behavior. Measurements of behavior often correlate to a modest extent with pain report. They may also add to the understanding of the impact of pain. And, in certain circumstances, e.g. in very young children and demented or unresponsive patients, they may need to substitute for pain report (Weiner et al., 1999). However, in most circumstances, neither behaviors nor laboratory measurements can replace the subject’s pain report.

Now consider a second question about the same research case problem.

 

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