The purpose of this study is to evaluate two experimental pain models to see if they would be useful for comparing different products for reduction in pain intensity. The models evaluated were the ultraviolet-B (UVB) burn and intradermal capsaicin experimental pain models. Medications compared were a single dose each, of intravenous (IV) acetaminophen, oral acetaminophen, placebo, and IV morphine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
79
Acetaminophen administered by intravenous (IV) infusion
Acetaminophen administered by oral tablets
Placebo administered by IV infusion or oral tablets
Pharmaceuticals Research Associates, Inc. (PRA)
Salt Lake City, Utah, United States
Part 1: Change From Baseline in Pain Intensity at Hour 6 Using the Thermal Suprathreshold Pain in the Ultraviolet-B (UVB) Burn Pain Model
The UVB burn pain model is a validated screening tool for pain killers in clinical drug development. A temperature of 50 degrees centigrade (°C) is used to burn the participant for 5 seconds. Then the participant rates his pain on a scale from 0 (no pain) to 10 (most intense pain). That score is recorded as baseline. Then the participant rates his pain again six hours after taking the assigned medication. The average at baseline is subtracted from the average at hour 6. Because this is a measure of reduction in pain intensity, a higher score is better (it means there is more pain relief).
Time frame: within 6 hours
Part 2: Observed Thermal Suprathreshold Pain Intensity in the UVB Burn Area
Participants rated their pain intensity on a scale of 0 (no pain) to 10 (most intense pain). The observed mean and standard deviation are disclosed through Hour 6
Time frame: within 6 hours
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Morphine administered by IV infusion