Journal of pain and symptom management · 2016
Pharmacokinetics of Phenobarbital in Microenema Via Macy Catheter Versus Suppository.
СтатьяРандомизированное исследованиеПоддержка правительства СШАНазвание и аннотация: Перевод в очереди
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Lam Y W Francis, Lam Ansom, Macy Brad
Аннотация
CONTEXT: The oral route is compromised for nearly all patients approaching death. When agitation, seizures, or other intractable symptoms occur, a quick, discreet, comfortable, and effective alternate route for medication delivery that is easy to administer in the home setting is highly desirable.
OBJECTIVES: To characterize the early absorption profile, variability, and comfort of phenobarbital given in microenema suspensions delivered via the Macy Catheter(®) (MC) vs. the same dose given via suppository.
METHODS: This was a randomized, open-label, crossover study comparing the early absorption profile of equal doses of phenobarbital administered rectally in three treatment phases: phenobarbital suppository and two different microenemas with phenobarbital tablets crushed and suspended in 6 mL (MC-6) or 20 mL (MC-20) of tap water.
RESULTS: Mean plasma phenobarbital concentrations at 10 minutes were 12× higher for MC-20 and 8× higher for MC-6 compared to suppository. Concentrations achieved in 30 minutes via MC-20 took almost three hours to achieve with suppository. Mean AUC values were higher for MC-20 and MC-6 (82% and 46%, respectively) vs. suppository (P < 0.05). There was less variability in absorption for MC-20 and MC-6 (1.4- to 1.9-fold difference) compared to a 4.4-fold difference via suppository. MC administrations were reported as "not uncomfortable" compared to suppositories, which were reported as "mildly uncomfortable" (P < 0.05).
CONCLUSION: These results suggest phenobarbital oral tablets crushed and suspended in water and administered via the MC is superior to suppository in delivering the medication reliably and rapidly.
OBJECTIVES: To characterize the early absorption profile, variability, and comfort of phenobarbital given in microenema suspensions delivered via the Macy Catheter(®) (MC) vs. the same dose given via suppository.
METHODS: This was a randomized, open-label, crossover study comparing the early absorption profile of equal doses of phenobarbital administered rectally in three treatment phases: phenobarbital suppository and two different microenemas with phenobarbital tablets crushed and suspended in 6 mL (MC-6) or 20 mL (MC-20) of tap water.
RESULTS: Mean plasma phenobarbital concentrations at 10 minutes were 12× higher for MC-20 and 8× higher for MC-6 compared to suppository. Concentrations achieved in 30 minutes via MC-20 took almost three hours to achieve with suppository. Mean AUC values were higher for MC-20 and MC-6 (82% and 46%, respectively) vs. suppository (P < 0.05). There was less variability in absorption for MC-20 and MC-6 (1.4- to 1.9-fold difference) compared to a 4.4-fold difference via suppository. MC administrations were reported as "not uncomfortable" compared to suppositories, which were reported as "mildly uncomfortable" (P < 0.05).
CONCLUSION: These results suggest phenobarbital oral tablets crushed and suspended in water and administered via the MC is superior to suppository in delivering the medication reliably and rapidly.