Uptake pharmacokinetics of the Fentanyl Oralet® in children scheduled for central venous access removal

Implications for the timing of initiating painful procedures

Melissa Wheeler*, Patrick K Birmingham, Richard Dsida, Zhao Wang, Charles J. Coté, Michael J Avram

*Corresponding author for this work

Research output: Contribution to journalArticle

36 Citations (Scopus)

Abstract

Background: The Fentanyl Oralet® (Abbott Laboratories, Abbott Park, IL, USA) is an oral transmucosal drug delivery system. We previously examined pharmacokinetic parameters of children who had completed consumption of the Fentanyl Oralet®. The present study was designed to clarify pharmacokinetic parameters during the consumption phase to determine if there is an optimal administration time before painful procedures. Methods: Patients, aged 3-10 years, who were scheduled for elective removal of central venous access devices under general anaesthesia, received a Fentanyl Oralet® (fentanyl 10-15 μg·kg-1). Plasma fentanyl concentrations were measured by radioimmunoassay. Data from blood samples obtained during and after consumption of the Fentanyl Oralet® from 17 patients in the present study were combined with data from our previous study to better characterize both the consumption and postconsumption concentration versus time profiles. Results: Estimated fentanyl bioavailability (mean ± SD) was low (36.1 ± 0.4%), as were peak plasma concentrations (1.03 ± 0.31 ng·ml-1), suggesting that many children swallowed a large fraction of the dose. This led to a relatively late and variable peak concentration time of 53 ± 40 min. In addition, because of the apparently large degree of gastrointestinal absorption, concentration versus time curves were wide and flat. Conclusions: The wide and flat concentration versus time profile may allow flexibility in the timing of a painful procedure following Fentanyl Oralet® administration. However, the variability of the time to peak concentration makes it difficult to suggest a minimum interval between Fentanyl Oralet® consumption and the start of a painful procedure.

Original languageEnglish (US)
Pages (from-to)594-599
Number of pages6
JournalPaediatric Anaesthesia
Volume12
Issue number7
DOIs
StatePublished - Nov 14 2002

Fingerprint

Fentanyl
Pharmacokinetics
Drug Delivery Systems
General Anesthesia
Biological Availability
Radioimmunoassay
Equipment and Supplies

Keywords

  • Anaesthesia
  • Analgesia
  • Fentanyl
  • Fentanyl Oralet®
  • Premedication

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Anesthesiology and Pain Medicine

Cite this

@article{42e3a688530048d4abd973f6693c5613,
title = "Uptake pharmacokinetics of the Fentanyl Oralet{\circledR} in children scheduled for central venous access removal: Implications for the timing of initiating painful procedures",
abstract = "Background: The Fentanyl Oralet{\circledR} (Abbott Laboratories, Abbott Park, IL, USA) is an oral transmucosal drug delivery system. We previously examined pharmacokinetic parameters of children who had completed consumption of the Fentanyl Oralet{\circledR}. The present study was designed to clarify pharmacokinetic parameters during the consumption phase to determine if there is an optimal administration time before painful procedures. Methods: Patients, aged 3-10 years, who were scheduled for elective removal of central venous access devices under general anaesthesia, received a Fentanyl Oralet{\circledR} (fentanyl 10-15 μg·kg-1). Plasma fentanyl concentrations were measured by radioimmunoassay. Data from blood samples obtained during and after consumption of the Fentanyl Oralet{\circledR} from 17 patients in the present study were combined with data from our previous study to better characterize both the consumption and postconsumption concentration versus time profiles. Results: Estimated fentanyl bioavailability (mean ± SD) was low (36.1 ± 0.4{\%}), as were peak plasma concentrations (1.03 ± 0.31 ng·ml-1), suggesting that many children swallowed a large fraction of the dose. This led to a relatively late and variable peak concentration time of 53 ± 40 min. In addition, because of the apparently large degree of gastrointestinal absorption, concentration versus time curves were wide and flat. Conclusions: The wide and flat concentration versus time profile may allow flexibility in the timing of a painful procedure following Fentanyl Oralet{\circledR} administration. However, the variability of the time to peak concentration makes it difficult to suggest a minimum interval between Fentanyl Oralet{\circledR} consumption and the start of a painful procedure.",
keywords = "Anaesthesia, Analgesia, Fentanyl, Fentanyl Oralet{\circledR}, Premedication",
author = "Melissa Wheeler and Birmingham, {Patrick K} and Richard Dsida and Zhao Wang and Cot{\'e}, {Charles J.} and Avram, {Michael J}",
year = "2002",
month = "11",
day = "14",
doi = "10.1046/j.1460-9592.2002.00949.x",
language = "English (US)",
volume = "12",
pages = "594--599",
journal = "Paediatric Anaesthesia",
issn = "1155-5645",
publisher = "Wiley-Blackwell",
number = "7",

}

TY - JOUR

T1 - Uptake pharmacokinetics of the Fentanyl Oralet® in children scheduled for central venous access removal

T2 - Implications for the timing of initiating painful procedures

AU - Wheeler, Melissa

AU - Birmingham, Patrick K

AU - Dsida, Richard

AU - Wang, Zhao

AU - Coté, Charles J.

AU - Avram, Michael J

PY - 2002/11/14

Y1 - 2002/11/14

N2 - Background: The Fentanyl Oralet® (Abbott Laboratories, Abbott Park, IL, USA) is an oral transmucosal drug delivery system. We previously examined pharmacokinetic parameters of children who had completed consumption of the Fentanyl Oralet®. The present study was designed to clarify pharmacokinetic parameters during the consumption phase to determine if there is an optimal administration time before painful procedures. Methods: Patients, aged 3-10 years, who were scheduled for elective removal of central venous access devices under general anaesthesia, received a Fentanyl Oralet® (fentanyl 10-15 μg·kg-1). Plasma fentanyl concentrations were measured by radioimmunoassay. Data from blood samples obtained during and after consumption of the Fentanyl Oralet® from 17 patients in the present study were combined with data from our previous study to better characterize both the consumption and postconsumption concentration versus time profiles. Results: Estimated fentanyl bioavailability (mean ± SD) was low (36.1 ± 0.4%), as were peak plasma concentrations (1.03 ± 0.31 ng·ml-1), suggesting that many children swallowed a large fraction of the dose. This led to a relatively late and variable peak concentration time of 53 ± 40 min. In addition, because of the apparently large degree of gastrointestinal absorption, concentration versus time curves were wide and flat. Conclusions: The wide and flat concentration versus time profile may allow flexibility in the timing of a painful procedure following Fentanyl Oralet® administration. However, the variability of the time to peak concentration makes it difficult to suggest a minimum interval between Fentanyl Oralet® consumption and the start of a painful procedure.

AB - Background: The Fentanyl Oralet® (Abbott Laboratories, Abbott Park, IL, USA) is an oral transmucosal drug delivery system. We previously examined pharmacokinetic parameters of children who had completed consumption of the Fentanyl Oralet®. The present study was designed to clarify pharmacokinetic parameters during the consumption phase to determine if there is an optimal administration time before painful procedures. Methods: Patients, aged 3-10 years, who were scheduled for elective removal of central venous access devices under general anaesthesia, received a Fentanyl Oralet® (fentanyl 10-15 μg·kg-1). Plasma fentanyl concentrations were measured by radioimmunoassay. Data from blood samples obtained during and after consumption of the Fentanyl Oralet® from 17 patients in the present study were combined with data from our previous study to better characterize both the consumption and postconsumption concentration versus time profiles. Results: Estimated fentanyl bioavailability (mean ± SD) was low (36.1 ± 0.4%), as were peak plasma concentrations (1.03 ± 0.31 ng·ml-1), suggesting that many children swallowed a large fraction of the dose. This led to a relatively late and variable peak concentration time of 53 ± 40 min. In addition, because of the apparently large degree of gastrointestinal absorption, concentration versus time curves were wide and flat. Conclusions: The wide and flat concentration versus time profile may allow flexibility in the timing of a painful procedure following Fentanyl Oralet® administration. However, the variability of the time to peak concentration makes it difficult to suggest a minimum interval between Fentanyl Oralet® consumption and the start of a painful procedure.

KW - Anaesthesia

KW - Analgesia

KW - Fentanyl

KW - Fentanyl Oralet®

KW - Premedication

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U2 - 10.1046/j.1460-9592.2002.00949.x

DO - 10.1046/j.1460-9592.2002.00949.x

M3 - Article

VL - 12

SP - 594

EP - 599

JO - Paediatric Anaesthesia

JF - Paediatric Anaesthesia

SN - 1155-5645

IS - 7

ER -