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Rapp 1989
Rapp 1989
ABSTRACf: Patient-controlled analgesia (PCA) is a major advance in this article is to review the data in support of the effective-
the management of pain in postoperative and cancer patients. The ness of PCA and to evaluate the currently available PCA
success of PCA has resulted in a proliferation of marketed devices to
devices.
administer small bolus doses of parenteral pain-control drugs at fixed
intervalscontrolled by the patient with the push of a button. Because
patientsdemonstrate marked individual variation in pain medication Pain and Traditional Narcaic Administration
requirements, PCA devices should be able to accommodate rapidly The principal impetus for the development of PCA has
changing requirementsfor drugs with a minimum amount of effort on
behalf of health care personnel. Crude electronicdevices were
been the failure of traditional techniques, primarily the pro
developedin the late 1960sand the early 1970sand usually consisted intramuscular administraton of narcotic analgesics, to ade-
of a syringe pump connected to some sort of timing device. Most quately manage pain. The effective management of pain
modem PCA devices marketed in the past five years are much more has long been a major clinical challenge despite the avail-
sophisticated devices that are microprocessorbased and some newer ability and use of potent narcotic analgesics. Patients dem-
devices even generate hard copy for a permanent record of drug onstrate marked variability in analgesic requirements,
administration. Although many such devices are available(includinga
totallydisposable PCA device), few have undergone extensiveclinical
dosing intervals, and tolerance to adverse effects. In the
evaluation. A review of the literature shows many devices are acute setting, traditional pro intramuscular narcotics have
available for use without a single publicationto document the safety been inappropriately dosed a large proportion of the
and utility of the device in the routine patient care situation. Use of time.r" Marks and Sachar found that 73 percent of inpa-
the PCA method of pain control will grow, and all hospital-based tients receiving an average of 90 mg/d of im meperidine had
healthcare personnel should become familiar with their use and severe or moderate distress." Similarly, Cohen found 75
limitations. percent of postoperative patients treated with standard im
D1CP 1989;23:899-904. narcotics to be in marked or moderate distress. 5 Such stud-
ies also have found that with traditional pro medication
administration techniques patients are often underdosed at
PATIENT-CONTROLLED ANALGESIA (PCA) is recognized as a times of peak pain and overdosed to sedation when pain is
major advance in the management of pain for a wide variety less severe. 3-5
of clinical problems. I PCA employs an infusion pump inte- Many factors contribute to the inadequacy of postopera-
grated with a timing device that allows patients to self- tive analgesia. The treatment of postoperative pain has
administer small doses of narcotics intravenously. Using a most frequently used an every four to six hour schedule of
PCA device, a patient may self-administer an analgesic im medications given at the discretion of the nursing staff
when pain is perceived and experience a virtually immedi- on a pro basis.v' This process involves the pain cycle
ate analgesic effect. The dose and frequency for the anal- (Figure I) as described by Graves et al." and includes
gesic are controlled to prescribed limits by the settings of problems such as: (I) the potential for significant delays
the device. In a large number of clinical studies, PCA has between the perception of pain and the administration of
been shown to be a safe, effective, and economical means pain medication, (2) the high variability in absorption with
of managing pain. 2 im analgesics and a narrow effective range of serum levels,
As the concept of PCA has been validated, there has (3) the minimum serum concentration of drug to achieve
been a proliferaton of marketed devices. The data in sup- analgesia is exceeded for only 35 percent of the dosing
port of these devices are highly variable. The purpose of interval, and (4) peak concentrations of analgesic may vary
as much as fivefold in patients given the same im doses at
ROBERT P. RAPP, !'harm.D., is a Professor and the Chairman, Divisionof Pharmacy the same dosing interval.
Practice and Science, College of Pharmacy, University of Kentucky, Lexington, KY
40536:BRACK A. BIVINS, M.D.• is the Director. Divisionof Traumaand Emergency
Research has emphasized the importance of pain man-
Surgery. Henry Ford Medical Center, Detroit. MI; ROBERT A. LITTRELL, agement." For example, the fear of pain may lead to
!'harm.D.• isa PainManagementPharmacist,University Hospital,Departmentof Phar- delays in seeking care. In the postoperative period inade-
macy Central Supply, Lexington. KY; and 11I0MAS S. FOSTER, !'harm.D., is a
Imfessor and the Director, Caller for Pharmaceutical Science and ThchnoIogy. CoUege of
quately controlled pain may lead to decreased ambulation
Pharmacy. University of Kentucky, Lexington, KY.ReprInts: RobertP. Rapp,!'harm.D. and poor pulmonary toilet. Other problems with pain man-
J
"
cal practice the adequate control of pain should be a goal
achieved through communication and cooperation among injection given sign out medication
all health professionals. 11
Given the problems associated with traditional im nar- Figure I. Conventional pain therapy cycle.
cotic administration, a system such as PCA, which allows
for individual variation in analgesic requirements, should
be accepted by both medical personnel and patients. The
concept of small, bolus doses of narcotics as an analgesic especially for patients with terminal cancer pain that require
technique has been present for over 25 years. In 1963 Roe increasing doses of analgesics. 19,20
demonstrated that small iv doses of analgesics gave more
effective pain relief than im doses. Unfortunately, the man-
Therapeutic EjJicQ£Y
ually administered iv bolus system had several negative In a prospective, randomized trial, Bennett et al. com-
aspects, including a very short duration of pain relief with pared PCA morphine sulfate with morphine sulfate 8-12
small doses and an unacceptably high incidence of seda- mg im q4-6h prn. Patients in the PCA group maintained a
tion, respiratory depression, nausea, and vomiting with state of adequate analgesia without sedation compared with
higher doses." Using a manual administration system the im group, who exhibited more sedation between 6 a.m.
monitored by a "nurse observer," Sechzer noted in 1968 and 10 p.m. The PCA group showed greater sedation dur-
that small doses of iv analgesics were effective. However, ing regular sleeping hours. Patients and nursing staff were
he also found that patient variations in dose requirements more satisfied with PCA-administered morphine. Only in
were cyclic and inconsistent. 13 Even if these early systems the PCA group were patients able to meet the wide varia-
had been completely acceptable clinically, the nursing time tion seen in the amount of morphine required." Numerous
required by the manual infusion techniques would be pro- studies have verified the high level of patient satisfaction
hibitive in today's financially controlled hospital environ- seen in PCA-administered analgesics.P-" A comparative
ment and would be further limited by the nursing shortage trial of nursing-controlled continuous infusion morphine
affecting most areas of the U.S. (i.e., the nurse increased the infusion rate when the patient
The early studies of intermittent bolus dosing of anal- complained of pain and decreased the rate when the patient
gesics hinted at the potential of PCA. The rapid progress in seemed to be sedated) versus regularly scheduled im mor-
microprocessor electronics in hospital infusion control phine given q4h demonstrated an improvement in postop-
equipment of the 1970s allowed the medical electronics erative pulmonary function in the continuous infusion
industry to design specific devices for administration of group." Other investigators have shown better pulmo-
small iv doses of analgesics. With these devices incorporat- nary function in patients using PCA compared with stan-
ing safeguards against overinfusion, excess sedation, and dard im prn regimens." Two studies have shown that, in
respiratory depression, analgesic administration could be spite of better analgesia in the patients receiving PCA, the
controlled in most cases by the patient. 14 total dose of morphine required is less than that in patients
The first electronic PCA devices were developed in the receiving im drugs. 27 ,28 Other studies, however, have not
late 1960s and early 1970s. These devices were rather crude demonstrated similar findings but still find a high level of
by today's standards and consisted of a syringe pump con- patient satisfaction when PCA is used. 24,29 Graves et al.
nected to a timing device. The patient activated the syringe demonstrated a diurnal morphine dosing rhythm in mor-
pump by depressing a hand-held button connected to a bidly obese patients undergoing gastric bypass. Peak mor-
timing and lockout device.9.1s-18 phine use occurred at 9 a.m. and was lowest at 3 p.m. This
Today, there are a number of electronic PCA devices on difference was statistically significant and was postulated to
the market as well as a recently introduced nonelectronic be related to the diurnal variation in adrenocorticotropic
device that uses manually applied power rather than electri- hormone and pituitary secretion of beta-endorphins. Adap-
cal line power to deliver the bolus of medication. Table I tation of drug dosing to drug diurnal requirements could be
lists the major characteristics of PCA devices presently accomplished only with the PCA system of administra-
available in the U.S. Many of these devices have additional tion."
capability including the administration of bolus loading The risk of clinically significant adverse effects associ-
dose, the infusion of a baseline dose of drug together with a ated with PCA appears to be quite low. Initial fears of
demand bolus dose, storage of patient data for various time respiratory depression with commonly used doses of ago-
periods, and the generation of hard copy of patient data for nist narcotic analgesics have been shown to be unfounded.
nursing records in addition to small prn bolus doses." Patients undergoing many different types of major surgery
There also are a number of research/clinical projects that have had consistently normal arterial blood gases with
have evaluated the use of home PCA devices designed PCA use in the postoperative period.t'-" Respiratory
mechanics have also been shown to remain normal in clini- tion programs and by insuring that personnel follow written
cal trials with PCA.33.34 hospital procedures in all phases of set up. One report of a
PCA also may offer some advantages in terms of com- patient's death from what may have been a pump malfunc-
plications of narcotic adverse effects." Narcotics can pro- tion has been published." The patient's family and
duce a variety of adverse effects including nausea, friends must be instructed not to "push the button" for the
sedation, respiratory depression, and pruritus. Narcotic patient. In our experience, family interference (albeit well
addiction and/or withdrawal in patients being treated for intentioned) with the pain control cycle has resulted in
acute pain develops rarely and does not appear to be a additional narcotic administration to a comfortable or
clinically significant problem. sleeping patient. This may obviously cause adverse effects
One narcotic adverse effect that appears to be related to with PCA therapy. Routine cleaning and sound mainte-
administration technique is pruritus, which is particularly nance of the PCA control device are necessary to ensure
bothersome in patients receiving epidural narcotics. In a that mechanical malfunctions are minimal as with any
randomized trial comparing epidural PCA and im mor- patient care microprocessor-based equipment. Since PCA
phine, Eisenach et al. found that 85 percent of patients systems usually are connected to a peripheral catheter,
treated with epidural morphine complained of pruritus and problems associated with the catheter will influence the
40 percent required treatment with systemic medications success of pain management. The outpatient use of PCA by
for relief of symptoms. Pruritus was significantly less in the subcutaneous route has been reported; this would over-
both the PCA and im morphine groups.v Another com- come the problems associated with maintaining an indwell-
parative trial has shown similar results. 37 ing venous catheter. 40
The main concerns with patient safety with PCA appear
PeA Devices
to be associated with operator error." White reported two
cases in which overdoses of PCA-administered narcotics Many PCA devices are now commercially available and
occurred. The first case involved a programming error and use a variety of different technologies to store and adminis-
the second involved the inadvertent administration of a ter small bolus doses of the drug. Most devices use a
bolus dose of sufentaniI. 38 Errors of this type are best syringe system with a "screw driven" motor to depress the
avoided by conducting rigorous nursing inservice educa- plunger of the syringe. The motor is interfaced with the
LOCKOUT
PREALLED SECURITY INTERVAL
DEVICE NAME FUNCTIONS BOLUS SYRINGE SYSTEM RANGE
history of patient attempts versus actual injections is 2. MCKENNA TR, BRANIGAN TA,SORACKE AH. Phannacy-initiated intro-
unavailable. A separate plastic case that can secure the duction of patient-controlled analgesiato a 400-bed communityhospi-
tal, Am J Hosp Pharm 1989;46:291-4.
infusor to the bed rail can be purchased. The entire device is 3. SRIWATANAKUl K, WEIS OF, ALlOZA n, et aI. Analysis of narcotic
disposable. analgesic usage in the treatment of postoperative pain. .b\MA 1983;
Wermeling et al. evaluated the Baxter device in 50 250:926-9.
postoperative patients. Pain relief was satisfactory in about 4. MARKS RM, SACHAR fJ. Undertreatment of medical inpatients with
90 percent of patients although the drug concentration had narcotic analgesics. Ann Intern Med 1973;78:173-81.
to be changed in 18.8 percent of patients (10 of 53) to obtain 5. COHEN FL. Postsurgical pain relief: patient's status and nurses' medica-
tion choices, Pain 1980;9:265-74.
pain relief." Since a new infusor must be prepared by the 6. UTTLINGJE, SMITH JM. Postoperative analgesia. Anaesthesia 1979;
pharmacy when a dose change is required, this must be 34:320-32.
considered in evaluating the Baxter PCA system against the 7. HUGCC Jr. Improvinganalgesictherapy. Anesthesiology 1980;53:441-3.
electronic devices. For example, a 24-hour pharmacy 8. GRAVES DA, FOSTER TS, BATENHORST RL, et aI. Patient-controlled
admixture service may be a necessary feature to handle analgesia. Ann Intern Med 1983;99:360-6.
dosing changes when the disposable system is considered. 9. EVANS 1M, ROSEN M, MACCARTHY J, HOGGMil. Apparatusfor patient-
controlledadministration of intravenous narcoticsduring labor. Lancet
Gallion et aI. provided PCA with the disposable device to 1976;/:17-8.
20 patients undergoing abdominal hysterectomy. The 10. ANGEll M. The quality of mercy. N Engl J Med 1982;306:98-9.
device was effective in controlling pain and well accepted II. Panel cites need for improved pain-management. Clin Pharm 1986;
by the patients. so 5:777-8.
12. ROE BB. Are postoperative narcotics necessary? Arch Surg 1963;
GRASEBY PeAS PUMP 87:912-5.
13. SECHZER PH. Objective measurement of pain. Anesthesiology 1968;
The Graseby PCA System (PCAS) is the modern ver- 29:209-10.
sion of one of the first PCA prototype devices known as the 14. Patient-controlled analgesic infusion pumps. Health Devices 1988;
Cardiff Palliator. Although not known well in the U.S., 17:136-67.
extensive clinical documentation has been published in the 15. SCHZER PH. Studies in pain with the analgesic-demand system. Anesth
United Kingdom and New Zealand. 17 ,18,Sl-S3 The Graseby Analg 1971;50:1-10.
16. KEERJ-SZANTO M. Apparatusfor demand analgesia. CanAnaesthSocJ
unit will accept a 6O-mL disposable syringe and is pro- 1971; 18:581-2.
grammed in milligrams. No prefilled syringes are avail- 17. HARMER M, SLATTERY OJ, ROSEN M, VICKERS MD. Comparison
able. To achieve security for the narcotic syringe container between buprenorphine and pentazocine given iv on demand in the
a separate syringe hood must be acquired; otherwise, the control of postoperative pain. Br J Anaesth 1983;55:21-4.
syringe is not tamperproof. 18. GIBBS JM, JOHNSON HD, DAVIS FM. Patient administration of iv
buprenorphine for post-operative pain relief using the "Cardiff"
OTHER DEVICES demand analgesia apparatus. Br J Anaesth 1982;54:278-84.
19. CITRON ML, JOHNSTON-EARLY A, BOYER M, et aI. Patient-eontrolled
There are at least six other PCA devices currently being analgesia for severe cancer pain. Arch Intern Med 1986;146:134-6.
marketed, including Becton Dickinson PCA Infusor, Strato 20. TWYCROSS RG, FAIRFIELD S. Pain in far-advanced cancer. Pain 1982;
Stratofuse PCA, Pancretec Provider 5000, Pharmacia 14:303-10.
Deltec CADD-PCA Pump, MiniMed PCA Pump, and the 21. BENNETI RL, BATENHORST RL, BIVINS BA, et aI. Patient-controlled
Bard Ambulatory PCA Pump. Unfortunately, for these six analgesia-a newconceptof postoperative pain relief. AnnSurg 1982;
PCA devices, no clinical documentation of their safety and 195:700-5.
22. DAHLlB, DAUSAARD JJ,LARSEN HY, et aI. Patient-controlled analgesia:
effectiveness is available. However, information about a controlled trial. Acta Anesthesiol Scand 1987;3/:744-7.
these devices is available in the ECRI report" and a recent 23. ALBERT JM, TALBOTITM. Patient-controlled analgesiavs conventional
review of high technology infusion devices is also an addi- intramuscular analgesia following colon surgery. Dis Colon Rectum
tional source of information. 54 1988;3/:83-6.
24. BOlLISH SJ, COLLINS ci, KlRKINS DM, BARTLETI RH. Efficacy of
patient-controlled versus conventional analgesia for post-operative
Summary pain. Clin Pharm 1985;4:48-52.
PCA appears to be, at present, the best way to meet the 25. NAYMAN 1. Measurementand control of postoperative pain. Ann R Coli
Surg EngI1979;6/:419-26.
variable needs of patients experiencing moderate to severe 26. BENNETI RL, BATENHORST RL, FOSTER TS, et aI. Postoperative pul-
pain. Traditional im pain management does not achieve the monary function with patient controlled analgesia (abstract). Anesth
success shown with PCA and, in many cases, the patient is Analg 1982;6:171.
either underdosed or oversedated. The PCA concept allows 27. KEERJ-SZANTO M, HEAMAN S, Postoperative demand analgesia. Surg
the patient to be an active participant in pain management. GynecolObstet 1972;/34:647-51.
PCA has gained widespread acceptance among physicians, 28. KLUMAN RL, LIPMAN AG, HAREBD, MACDONALD SD. A comparison
nurses, pharmacists, and administrators as an effective of morphineadministeredby patient-controlled analgesiaand regularly
scheduled intramuscularinjection in severe postoperative pain. J Pain
approach to pain control in many clinical settings. Symp Manag 1988;3:15-22.
The future will bring a multitude of new, probably better, 29. BENNETRL, BATENHORST RL, GRAVES D, et aI. Drug use pattern in
more sophisticated devices as PCA gains increasing clini- patient-controlled analgesia (abstract). Anesthesiology 1982;
cal acceptance. It is hoped that this will lead to the optimal 57(suppl):A-21O.
management of pain in the clinical setting.s> 30. GRAVES DA, BATENHORST RL, BENNETI RL, et. aI. Morphinerequire-
ments using patient-controlled analgesia: influenceof diurnal variation
and morbid obesity. Clin Pharm 1983;2:49-53.
References 31. WHITEDC, PEARCH OJ, NORMAN 1. Postoperative analgesia-a com-
I. BENNETI RL, BAUMANN rr, BATENHORST RL, et aI. Morphinetitration parison of intravenous on-demandfentanylwith epidural bupivacaine.
in postoperative laparatomypatientsusingpatient-eontrolled analgesia. Br Med J 1979;2:166-7.
Curr Ther Res 1982;32:45-52. 32. TAMSEN A, HARTVIG P, FAGERLUND C, et aI. Patient controlled anal-