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Transdermal Fentanyl for Postoperative Pain Management: Title and subTitle BreakA Double-blind Placebo Study FREE

Robert A. Caplan, MD; L. Brian Ready, MD; Rollin V. Oden, MD; Frederick A. Matsen, III, MD; Michael L. Nessly; Gayle L. Olsson, RN, MN
[+] Author Affiliations

Reprint requests to Virginia Mason Medical Center, Anesthesiology Department, (B2-AN), PO Box 900, Seattle, WA 98111 (Dr Caplan).


JAMA. 1989;261(7):1036-1039. doi:10.1001/jama.1989.03420070086036
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A double-blind, placebo-controlled, randomized design was used to evaluate the safety and efficacy of transdermal fentanyl citrate for postoperative pain management in 42 healthy adult patients undergoing major shoulder surgery. Transdermal systems rated to deliver fentanyl citrate at a rate of 75 μg/h were applied to the skin immediately prior to surgery and worn for 24 hours. Patients in the active group required significantly less morphine than the placebo group during the 24-hour period that systems were in place (0.8 ±0.61 vs 1.3 ±0.64 mg/h) and for the first 12 hours after removal (0.3 ± 0.36 vs 0.5 ± 0.32 mg/h). The incidence of vomiting was more frequent in the active group than in the placebo group (73% vs 30%), and respiratory rate in the active group was lower than in the placebo group during the 13- to 24-hour interval of system application (14±3 vs 16±2 breaths per minute). Nevertheless, transdermal fentanyl appears to be safe and effective after orthopedic surgery in healthy adult patients.

(JAMA 1989;260:1036-1039)

REFERENCES

Cleary GW:  Transdermal controlled release systems , in Langer RS, Wise DL (eds): Medical Applications of Controlled Release . Boca Raton, Fla, CRC Press, 1984;, vol 1, pp 204-251.
Michaels AS, Chandrasekaran SK, Shaw JE:  Drug permeation through human skin: Theory and in vitro experimental measurement . Am Inst Chem Eng J 1975;;21:985-996.
Caplan RA, Ready LB, Olsson GL, et al:  Transdermal delivery of fentanyl for postoperative pain control, abstracted . Anesthesiology 1986;;65:A196.
Holley FO, van Stennis C:  Postoperative analgesia with fentanyl: Pharmacokinetics and pharmacodynamics of constant-rate IV and transdermal delivery . Br J Anaesth 1988;;60:608-613.
Duthie DJR, Rowbotham DJ, Wyld R, et al:  Plasma fentanyl concentrations during transdermal delivery of fentanyl to surgical patients . Br J Anaesth 1988;;60:614-618.
Plezia PM, Linford J, Kramer TH, et al:  Transdermal therapeutic system (fentanyl) for postoperative pain: An efficacy, toxicity, and pharmacokinetic trial, abstracted . Anesthesiology 1986;; 65:A210.
Rigg JRA, Browne RA, Davus C, et al:  Variation in the disposition of morphine after IM administration in the surgical patient . Br J Anaesth 1978;;50:1125-1130.
Mather LE, Lindop MJ, Tucket GT, et al:  Pethidine revisited: Plasma concentrations and effects after intramuscular injection . Br J Anaesth 1975;;47;1269-1275.
Stanski DR, Greenblatt DJ, Lowenstein E:  Kinetics of intravenous and intramuscular morphine . Clin Pharmacol Ther 1978;;24:52-59.
Austin KL, Stapleton JV, Mather LE:  Relationship between blood meperidine concentrations and analgesic response: A preliminary report . Anesthesiology 1980;;53:460-466.
Swenson EJ, Orkin FK:  Postoperative nausea and vomiting , in Orkin FK, Cooperman LH (eds): Complications in Anesthesiology . New York, JB Lippincott, 1983;, pp 429-435.
Cousins MJ, Cherry DA, Gourlay GK:  Acute and chronic pain: Use of spinal opioids , in Cousins MJ, Bridenbaugh PO (eds): Neural Blockade in Clinical Anesthesia and Management of Pain , ed 2. New York, JB Lippincott, 1988;, pp 955-1029.
Riding JE:  Minor complications of general anesthesia . Br J Anaesth 1975;;47:91-101.
Marks RM, Sachar EJ:  Undertreatment of medical inpatients with narcotic analgesics . Ann Intern Med 1973;;78:173-181.
McCaffery M, Hart LL:  Undertreatment of acute pain with narcotics . Am J Nurs 1976;;76:1586-1591.
UttingJE, Smith JM:  Postoperative analgesia . Anaesthesia 1979;;34:320-332.
Cohen FL:  Postsurgical pain relief: Patients' status and nurses' medication choices . Pain 1980;;9:265-274.
Mather LE, Mackie J:  The incidence of postoperative pain in children . Pain 1983;;15:271-282.
Donovan M, Dillon P, McGuire L:  Incidence and characteristics of pain in a sample of medical-surgical patients . Pain 1987;;30:69-78.

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Cleary GW:  Transdermal controlled release systems , in Langer RS, Wise DL (eds): Medical Applications of Controlled Release . Boca Raton, Fla, CRC Press, 1984;, vol 1, pp 204-251.
Michaels AS, Chandrasekaran SK, Shaw JE:  Drug permeation through human skin: Theory and in vitro experimental measurement . Am Inst Chem Eng J 1975;;21:985-996.
Caplan RA, Ready LB, Olsson GL, et al:  Transdermal delivery of fentanyl for postoperative pain control, abstracted . Anesthesiology 1986;;65:A196.
Holley FO, van Stennis C:  Postoperative analgesia with fentanyl: Pharmacokinetics and pharmacodynamics of constant-rate IV and transdermal delivery . Br J Anaesth 1988;;60:608-613.
Duthie DJR, Rowbotham DJ, Wyld R, et al:  Plasma fentanyl concentrations during transdermal delivery of fentanyl to surgical patients . Br J Anaesth 1988;;60:614-618.
Plezia PM, Linford J, Kramer TH, et al:  Transdermal therapeutic system (fentanyl) for postoperative pain: An efficacy, toxicity, and pharmacokinetic trial, abstracted . Anesthesiology 1986;; 65:A210.
Rigg JRA, Browne RA, Davus C, et al:  Variation in the disposition of morphine after IM administration in the surgical patient . Br J Anaesth 1978;;50:1125-1130.
Mather LE, Lindop MJ, Tucket GT, et al:  Pethidine revisited: Plasma concentrations and effects after intramuscular injection . Br J Anaesth 1975;;47;1269-1275.
Stanski DR, Greenblatt DJ, Lowenstein E:  Kinetics of intravenous and intramuscular morphine . Clin Pharmacol Ther 1978;;24:52-59.
Austin KL, Stapleton JV, Mather LE:  Relationship between blood meperidine concentrations and analgesic response: A preliminary report . Anesthesiology 1980;;53:460-466.
Swenson EJ, Orkin FK:  Postoperative nausea and vomiting , in Orkin FK, Cooperman LH (eds): Complications in Anesthesiology . New York, JB Lippincott, 1983;, pp 429-435.
Cousins MJ, Cherry DA, Gourlay GK:  Acute and chronic pain: Use of spinal opioids , in Cousins MJ, Bridenbaugh PO (eds): Neural Blockade in Clinical Anesthesia and Management of Pain , ed 2. New York, JB Lippincott, 1988;, pp 955-1029.
Riding JE:  Minor complications of general anesthesia . Br J Anaesth 1975;;47:91-101.
Marks RM, Sachar EJ:  Undertreatment of medical inpatients with narcotic analgesics . Ann Intern Med 1973;;78:173-181.
McCaffery M, Hart LL:  Undertreatment of acute pain with narcotics . Am J Nurs 1976;;76:1586-1591.
UttingJE, Smith JM:  Postoperative analgesia . Anaesthesia 1979;;34:320-332.
Cohen FL:  Postsurgical pain relief: Patients' status and nurses' medication choices . Pain 1980;;9:265-274.
Mather LE, Mackie J:  The incidence of postoperative pain in children . Pain 1983;;15:271-282.
Donovan M, Dillon P, McGuire L:  Incidence and characteristics of pain in a sample of medical-surgical patients . Pain 1987;;30:69-78.
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