TY - JOUR
T1 - Assessment of the relative potency of fentanyl buccal tablet to intravenous morphine in healthy volunteers using a thermally induced hyperalgesia pain model
AU - Saunders, David L.
AU - Messina, John
AU - Darwish, Mona
AU - Xie, Fang
AU - Leary, Kevin J.
AU - Cantilena, Louis R.
PY - 2012/6
Y1 - 2012/6
N2 - This exploratory randomized, double-blind, placebo-controlled, 5-treatment, 5-period crossover study was conducted using a thermally induced hyperalgesia pain model in 51 healthy volunteers (33 evaluable) to characterize the relative potency of fentanyl buccal tablet (FBT) versus intravenous morphine. Relative potency was assessed using the sum of pain intensity differences over 60 minutes after the application of a 43°C, 46°C, and 49°C painful stimulus following thermally induced hyperalgesia. Relative potency was also assessed by pupil diameter and responses to subjective questionnaires. The relative potency of FBT was 46.2 times that of intravenous morphine (95% confidence interval [CI], 17.6-575.3) based on the 49°C stimulus. The relative potency of FBT based on opiate-induced miosis was 44.6 (95% CI, 29.7-77.0) at 60 minutes. These results are an initial relative potency assessment and should not be considered guidance for dose-equivalent switching between agents in clinical practice.
AB - This exploratory randomized, double-blind, placebo-controlled, 5-treatment, 5-period crossover study was conducted using a thermally induced hyperalgesia pain model in 51 healthy volunteers (33 evaluable) to characterize the relative potency of fentanyl buccal tablet (FBT) versus intravenous morphine. Relative potency was assessed using the sum of pain intensity differences over 60 minutes after the application of a 43°C, 46°C, and 49°C painful stimulus following thermally induced hyperalgesia. Relative potency was also assessed by pupil diameter and responses to subjective questionnaires. The relative potency of FBT was 46.2 times that of intravenous morphine (95% confidence interval [CI], 17.6-575.3) based on the 49°C stimulus. The relative potency of FBT based on opiate-induced miosis was 44.6 (95% CI, 29.7-77.0) at 60 minutes. These results are an initial relative potency assessment and should not be considered guidance for dose-equivalent switching between agents in clinical practice.
KW - analgesic effects
KW - fentanyl buccal tablet
KW - intravenous morphine
KW - relative potency
KW - thermally induced hyperalgesia
UR - http://www.scopus.com/inward/record.url?scp=84861837709&partnerID=8YFLogxK
U2 - 10.1177/0091270011407496
DO - 10.1177/0091270011407496
M3 - Article
C2 - 21646442
AN - SCOPUS:84861837709
SN - 0091-2700
VL - 52
SP - 870
EP - 879
JO - Journal of Clinical Pharmacology
JF - Journal of Clinical Pharmacology
IS - 6
ER -