Postoperative Pain Management With a Patient-Controlled Transdermal Delivery System for Fentanyl

Peter J. S. Koo

Am J Health Syst Pharm. 2005;62(11):1171-1176.

Conclusion

Fentanyl hydrochloride PCTS is a self-contained medication administration unit that provides patient control over pain management and consistent management of pain without analgesic peaks and troughs. It is safe and effective in the management of moderate to severe acute postoperative pain.

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Funding information

Dr. Koo has received honoraria for his membership on advisory boards sponsored by Ortho-McNeil.

Reprint Address

Peter J. S. Koo, Pharm.D., Department of Clinical Pharmacy and Pharmaceutical Services, School of Pharmacy, University of California, San Francisco, C-152, Box 062, 521 Parnassus Avenue, San Francisco, CA 94143-0622.

Cite this: Postoperative Pain Management With a Patient-Controlled Transdermal Delivery System for Fentanyl - Medscape - Jun 01, 2005.

Pharmacokinetics of Fentanyl Hydrochloride Delivered by Patient-Controlled Transdermal System After Single- and Multiple-Day Dosing ^a
Pharmacokinetic Variable^b	After One Day ( n = 25)	After Three Days ( n = 25)	p
C _max (µg/L)	0.30	0.48	0.0001
t _max (hr)	1.66	1.33	--
t (hr)	11.4	14.2	0.0001
AUC_0-5 (µg•hr/L)	1.20	1.88	0.0001
C _pre (µg/L)	0.21	0.34	0.0001
Corrected AUC_0-5 (µg•hr/L)	0.40	0.54	0.133

^aAdapted from reference 30, with permission.

^b C _max = maximum concentration; t _max = time to C _max; t = half-life; AUC_0-5 = area under the concentration-versus- time curve from zero to five hours; C _pre = predose concentration.

Effect of Subject Demographics on AUC _0-∞ ^a
Demographic Characteristic	n	Least-Squares Mean ± S.E.	Mean ± S.E. Difference	95% Confidence Interval	p
Race			-0.300 ± 1.560	-3.428 to 2.828	0.848
Black	28	2.98 ± 0.92
White	36	3.28 ± 1.08
Age (yr)			1.447 ± 1.467	-1.495 to 4.389	0.328
18-45	39	3.85 ± 0.75
>65	25	2.41 ± 1.15
Build			1.140 ± 1.279	-1.425 to 3.705	0.377
Lean	31	3.70 ± 0.98
Obese	33	2.56 ± 0.81
Sex			1.201 ± 1.577	-1.963 to 4.364	0.450
Female	27	3.73 ± 1.03
Male	37	2.53 ± 0.99

^aReproduced from reference 31, with permission. AUC_0-∞= area under the concentration-versus-time curve from zero hours to infinity.

Table 3. Secondary Efficacy Endpoints for Largest Placebo-Controlled Studies Comparing Fentanyl Hydrochloride Patient-Controlled Transdermal System (PCTS) With Placebo ^a
Endpoint	PCTS ( n = 235)	Placebo ( n = 204)	p
No. pts. withdrawing from study for any reason (%)	81 (34.5)	128 (62.7)	<0.0001
No. pts. with successful pain control (%)^b
PGA	179 (76.2)	106 (52.0)	<0.0001
IGA	176 (74.9)	107 (52.5)	<0.0001

^aData on file, ALZA Corp., Mountain View, CA, protocol C2001-011.

^bSuccessful pain control = a rating of pain control as excellent or good. PGA = patient global assessment, IGA = investigator global assessment.

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