Why the study?
Does codeine or aspirin improve analgesic activity compared to placebo in healthy volunteers using a modified cold stimulation technique?
Does codeine or aspirin improve analgesic activity compared to placebo in healthy volunteers using a modified cold stimulation technique?
A modified cold pressure technique with venous return occlusion offers a sensitive method for early assessment of analgesic activity, distinguishing codeine from placebo.
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Codeine outperforms placebo for analgesia in this RCT; confirms efficacy and validates the modified cold stimulation technique for early-phase research.
This report describes the effects of a modified cold pressure technique (MCP) on the dominant hand of 6 healthy right-handed volunteers, after single p.o. doses of codeine (60 mg), aspirin (1 g) and placebo in a cross-over, double-blind design. The method employed 9 serial tests on each study day, involving 5 consecutive 2 min periods of hand immersion in an equilibrating bath at constant temperature (37 degrees C), followed by a stimulating bath (0 degree C +/- 0.5) containing 15% ethylene glycol. For better control of peripheral circulatory temperature changes, a blood pressure cuff was inflated to 20 mm Hg below diastolic BP on the right upper arm, thereby preventing venous return from the lower arm during MCP stimulation. Although the test population was relatively small, the results showed a difference between aspirin, codeine and placebo. Codeine was statistically different from placebo (P less than 0.05). It is concluded that this modified technique offers a stable and sensitive method for the early assessment of analgesic activity.
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Jalón et al. (1985) studied this question.
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