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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 4.3
 
 

What is a potential pitfall of this design?

You answered:

Selection BA positive control intervention that increases the sustained-release opioid dose by 50% may not be large enough to produce significant reductions in pain or dose of rescue medication.


INCORRECT

Perhaps. A review of postoperative patient-controlled analgesia studies
(Max, 1994) found that only 3/15 treatments that augmented total opioid dose by a median value of 50% showed a statistically significant reduction in pain intensity or number of PCA boluses. I know of no published studies in the chronic oral dosing setting examining this question.



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