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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

Figure 4.2: graphic depiction of average pain intensity and hourly morphine intake for placebo or Drug K. For PCA Morphine, Drug K is significant at p<.05

100 patients with pain following hip replacement were randomized to receive a 24-hour infusion of either Drug K, a new compound that relieves pain in rats, or placebo. Patients in both treatment groups were allowed to self-administer intravenous morphine by a patient-controlled analgesic device. The figure shows average pain intensity and hourly morphine intake for the two groups: average pain intensity was similar, but patients receiving Drug K took significantly less PCA morphine than the placebo group.

 

Question 4.1.1

Does this result demonstrate that Drug K is an effective analgesic?

Yes          No

 

Question 4.1.2

Does this result demonstrate that measurement of morphine intake but not pain provided adequate "assay sensitivity" for the evaluation of Drug K as an analgesic?

Yes         No



 
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