Professional Documents
Culture Documents
Acetaminophen Analgesia in Neonatal Circumcision: The Effect On Pain
Acetaminophen Analgesia in Neonatal Circumcision: The Effect On Pain
Acetaminophen Analgesia in Neonatal Circumcision: The Effect On Pain
Cynthia R. Howard, MD*; Fred M. Howard, MDX; and Michael L. Weitzman, MD*
ABSTRACT. Objective. Recognizing the concerns shown to provide anesthesia and analgesia,9”12 but it
about the use of local anesthesia in neonatal circumcision, is not widely used due to concerns of sufficient
a painful procedure usually performed without analgesia safety,4’1#{176}the additional time required to perform the
or anesthesia, we undertook a study of acetaminophen for block, and the continued belief that the pain of neo-
pain management of this procedure.
natal circumcision is insignificant. The American
Design. A prospective, randomized, double-blind,
Academy of Pediatrics supports the use of anesthetics
placebo-controlled, clinical trial of acetaminophen anal-
gesia in 44 healthy full-term neonates undergoing circum- and analgesics in neonates and in its statement on
cision was conducted. Beginning 2 hours before Gomco neonatal anesthesia recommends that “the decision to
circumcision, neonates received either acetaminophen (15 withhold such medication should be based on the
mg/kg per dose, 0.15 mL/kg per dose) or placebo (0.15 same medical criteria used for older patients.”3
mL/kg per dose) every 6 hours for 24 hours. Neonates were Recognizing the concerns about the use of local an-
monitored intraoperatively for changes in heart rate, res- esthesia in neonatal circumcision, we undertook a
piratory rate, and crying time. Postoperative pain was as- study of acetaminophen for pain management of this
sessed at 30, 60, 90, 120, 360 minutes, and 24 hours using procedure. Acetaminophen is used extensively for re-
a standardized postoperative comfort scoring system.
lief of mild to moderate pain after minor surgery, has
Feeding behavior was also assessed before and after cir-
a broad margin of safety in infancy,’4 and is metabo-
cumcision by nursing observation.
Results. Neonates in both groups showed significant lized and excreted efficiently by newborns.’5-17 To test
increases in heart rate, respiratory rate, and crying during the hypothesis that acetaminophen alleviates intra-
circumcision with no clinically significant differences ob- operative and postoperative pain in neonatal circum-
served between the groups. Postoperative comfort scores cision, a prospective, randomized, double-blind,
showed no significant differences between the groups un- placebo-controlled, clinical trial of acetaminophen an-
til the 360-minute postoperative assessment, at which algesia in healthy full-term neonates undergoing cir-
time the acetaminophen group had significantly im- cumcision was conducted.
proved scores (P < .05). Feeding behavior deteriorated in
breast- and bottle-fed neonates in both groups, and acet- MATERIALS AND METHODS
aminophen did not seem to influence this deterioration.
Patient Population
Conclusions. This study confirms that circumcision of
the newborn causes severe and persistent pain. Acet- All male neonates who met the study criteria defined below
aminophen was not found to ameliorate either the intra- and who were delivered by the staff obstetrical service of Roch-
ester Ceneral Hospital from July 1992 to April 1993 were poten-
operative or the immediate postoperative pain of circum-
tially eligible to participate in the study. Rochester Ceneral Hos-
cision, although it seems that it may provide some benefit
pital is a 526-bed community hospital affiliated with the
after the immediate postoperative period. Pediatrics University of Rochester School of Medicine and Dentistry with
1994;93:641-646; neonatal circumcision, acetaminophen. approximately 2500 deliveries per year. Parents requesting cir-
cumcision of healthy, appropriate for gestational age, full-term
male newborns were asked to participate, and informed consent
Neonatal circumcision is the most common surgical was obtained for study participation. Full-term was defined as 37
procedure performed on males in the United States.1’2 to 42 weeks gestation. Further eligibility criteria were: (1) Apgar
As many as 86% of male neonates undergo this op- scores >7 at I and 5 minutes; (2) absence of any chronic or infec-
tious disease process; (3) no history of maternal illicit drug or
eration.3 It is unlikely that the frequency of this pro-
alcohol use; (4) absence of any other contraindication to circum-
cedure will decrease in the near future as the Amen- cision, such as hypospadias, epispadias, or cordee of the penis;
can Academy of Pediatrics has acknowledged that it and (5) no family history of a bleeding disorder. The study pro-
has possible medical benefits.4 Although there is clear tocol and consent form were approved by the hospital’s Clinical
neurophysiologic and clinical evidence that neonates Investigation Committee.
Assessment Score
0 2
Sleep during preceding None Short naps between 5 and Longer naps, >10 mm
hour 10 mm each each
Facial expression of pain Marked, constant Less marked, intermittent Calm, relaxed
Quality of cry Screaming, painful, high Modulated, can be dis- No cry
pitched tracted by normal sound
Consolability None after 2 mm Quiet after I mm of effort Calm before I mm of
effort
Sociability, eye contact, Absent Difficult to obtain Easy and prolonged
response to voice, smile,
real interest in face
Sucking Absence or disorganized Intermittent suck (3 or 4) Strong, rhythmic
suck and stops with crying pacifying effect
Spontaneous excitability Tremulous, clonic move- Excessive reactivity (to any Normal
and responsiveness to ments, spontaneous moro stimulation)
ambient stimulation reflexes
Spontaneous motor Thrashing around, incessant Moderate agitation Normal
activity agitation
Constant and excessive Very pronounced, marked, Less marked, intermittent Absent
flexion of fingers and toes and constant
Clobal evaluation of tone Strong hypertonicity Moderate hypertonicity Normal for age
Power calculations based on the results of the pilot test of the was born to a mother with pregnancy-induced hy-
Postoperative Comfort Score indicated that a group size of 18
pertension, whereas there were no obstetric compli-
neonates in each of the two test groups would allow detection of
a 50% improvement in Postoperative Comfort Scores with 80%
cations in the group receiving placebo. In all cases,
power and an a of .05 in a one-tailed analysis. neonates were asymptomatic at birth with normal
growth parameters and uneventful newborn courses.
Data Analysis There were no statistically significant differences in
Data analysis was performed using EPI Info, Version 5 (Centers unadjusted heart rate or respiratory rate (Table 2) be-
for Disease Control Shareware) and SPSS-PC statistical programs. tween the acetaminophen and placebo groups at any
Statistical comparisons were performed using the Student’s t-test
for normally distributed continuous data, and the Wilcoxon two-
stage of the circumcision procedure. Neonates in the
sample test for nonnormally distributed data. Categorical van- placebo group cried significantly more than those in
ables were tested for differences by x statistics, and 95% confi- the acetaminophen group during foreskin removal
dence intervals for proportions were calculated to examine the (Table 2, P < .05). These differences, however, were
variance of the point estimates. Fisher’s exact tests were used
not evident when crying times were adjusted for base-
whenever a cell size was <5. Differences between groups for Post-
operative Comfort Scores were analyzed using the Student’s t-test line crying time (Table 3). The analysis of adjusted
and analysis of variance techniques. Analysis of variance tech- mean heart rates showed that the acetaminophen
niques tested for differences between the groups with the preced- group had significantly greater changes in heart rate
ing comfort scores treated as a covaniate.
Comparisons between groups were also performed for all out-
during the clamp removal and recovery periods of the
come measures accounting for rates obtained in preoperative ob- procedure (P < .05 for each of these stages).
servations. Preoperative values were subtracted from subsequent There were no significant differences between the
measures of a particular pain measure to produce adjusted values.
groups at any designated postoperative pain assess-
Appropriate statistical analysis was then performed on these ad-
justed values.
ment for the behavioral state of the neonates before
scoring, time since last feeding, or for the numbers of
RESULTS painful procedures (eg, blood drawing or immuni-
There were no significant differences between the zation) which occurred within 30 minutes of a com-
study groups for birth weight, race, maternal age, ges- fort score. Significant differences occurred between
tational age, maternal smoking during pregnancy, preoperative scores and the 30-, 60-, 90-, 120-minute,
method of delivery, maternal use of intravenous or and 6-hour postoperative comfort scores in both
intramuscular analgesics during labor, maternal use groups. When preoperative and postoperative corn-
of local or epidural anesthesia during labor, Apgar fort scores were compared, significant changes oc-
scores at I and 5 minutes, method of infant feeding, curred in 9 of 10 and 8 of 10 components of the
age at circumcision, or time required for the proce- comfort score in the acetaminophen and placebo
dure. Only the incidence of obstetric complications groups, respectively.
differed between the groups. Two neonates in the ac- The t-test comparisons of comfort scores, adjusted
etaminophen group were born to mothers with ges- and unadjusted for preoperative values, revealed no
tational diabetes (non-insulin-dependent), and one significant differences between the groups at any of
TABLE 3. Changes in Intraoperative Heart Rates, Respiratory Rates, and Crying Times During Neonatal Circumcision Adjusted for
Baseline Values
C
0
U
U)
-2
Figure. Mean adjusted postop-
erative comfort scores after neona- E
0
tal circumcision: a comparison of 0
.
acetaminophen (n = 23) and pla- -3
C
cebo (n = 21) analgesia.
.4
. 30 Minutes
#{149}6
a acetaminophen
. placebo
the determinations (Figure and Table 4). Reanalysis of crease crying time.24 In the current study the observed
the data, however, via analysis of variance, with the changes in intraoperative heart rate, respiratory rate,
previous comfort score treated as a covariate, dem- and crying times were consistent with severe intra-
onstrated that the acetaminophen group was signifi- operative pain, and no clinically relevant differences
cantly more comfortable than the placebo group at the between the study groups for any of the intraopera-
6-hour postoperative score (P < .05). The 6-hour score tive pain measures were observed. Although differ-
occurred 2 hours after a dose of acetaminophen and ences were observed between groups for adjusted
at the time of maximal effect for the analgesic.’5’16 mean heart rates in the final two stages of the cir-
There were no significant differences between the cumcision procedure, they were unexpected because
groups for comfort scores at any other postoperative they occurred during the least invasive portions of the
time using this method of analysis. procedure, contrasted to all other outcome measures,
Preoperatively, all neonates fed well. Neonate feed- were not believed to be clinically relevant, and may
ing behavior after circumcision deteriorated in neo- have been the result of analysis of multiple measures.
nates in both groups. Of those breast-fed, 2 of 1 1 (18%) Acetaminophen, an analgesic of only mild to mod-
in the acetaminophen group and 3 of 8 (37%) in the erate potency, thus seems to be an ineffective anal-
placebo group either were judged to have breast-fed gesic for the management of the intraoperative pain
poorly or required formula feedings after circumci- associated with circumcision in the newborn.
sion. Of neonates who were formula-fed, 4 of 12(33%) Both groups of neonates showed significant dete-
in the acetaminophen group and 2 of 13 (15%) in the rioration in their comfort scores at all postoperative
placebo group fed poorly after circumcision. Acet- assessments. Although the number of neonates re-
aminophen did not significantly influence feeding maining in the hospital for the 24-hour assessment
changes for either breast-fed or formula-fed neonates. was small, postoperative scores in both groups at this
time had not returned to preoperative values. Other
DISCUSSION studies have documented changes in the Brazelton
Numerous studies have shown that circumcision Neonatal Behavioral Assessment secondary to cir-
causes severe intraoperative pain as measured by cumcision that have persisted for at least 24 hours.6’1’
changes in crying,8 heart rate, respiratory rate, tran- The overall deterioration in comfort scores observed
scutaneous Po2,’2’2#{176}
and cortiso! levels.9 Adequate an- in this study is consistent with these observations.
esthesia such as that provided by local anesthesia The results of this study also suggest that acet-
with lidocaine or dorsal penile nerve block has been aminophen is ineffective for pain management in the
shown to ameliorate changes in each of these immediate postoperative period (ie, the first 2 hours
parameters.9”2’2123 Additionally, simple interventions postcircumcision). Clinical experience with circumci-
like sucrose-flavored pacifiers have been shown to de- sion pain in older children validates this conclusion as
Preoperative 30 mm 60 mm 90 mm 120 mm 6 h 24 h
Acetaminophen 18.4 ± 1.3 14.9 ± 2.0 15.5 ± 2.6 15.0 ± 1.8 15.9 ± 2.0 17.1 ± 1.6* 16.7 ± 3.Ot
Placebo 18.4 ± 1.5 14.7 ± 2.5 15.0 ± 3.0 15.5 ± 2.0 15.8 ± 2.2 16.3 ± 2.3* 17.0 ± 1.9t
Adjusted for preoperative value
Acetaminophen -3.5 ± 2.2 -2.9 ± 3.1 -3.0 ± 2.1 -2.5 ± 2.5 -1.2 ± 2.0*
Placebo -3.7 ± 2.6 -3.4 ± 2.8 -2.7 ± 2.0 -2.6 ± 2.5 -2.0 ± 2,8*
* value <.05.
t Acetaminophen, n = 6; placebo, n = 5.
A woman was enraged (recently) because her health insurance company, after
paying for two unsuccessful attempts at in vitro fertilization, had refused to reim-
burse her for further infertility treatments. “They’re depriving me of my right to
become a mother,” she said, “and I’m going to sue them.”
But where is it written that our society owes everyone the “right” to become a
parent, regardless of the financial or ethical cost? ...
Almost no one has questioned the notion of parenthood as a right and infertility
as a disaster that must be fought with all the high-tech tools of modern medi-
cine . . . but when infertility is viewed simply as one misfortune on a scale of
sorrows-less horrible, say, than mind destroying diseases or mass starvation-the
ethical balance looks quite different.
Submitted by Student
Updated Information & including high resolution figures, can be found at:
Services http://pediatrics.aappublications.org/content/93/4/641
Permissions & Licensing Information about reproducing this article in parts (figures, tables) or in its
entirety can be found online at:
http://www.aappublications.org/site/misc/Permissions.xhtml
Reprints Information about ordering reprints can be found online:
http://www.aappublications.org/site/misc/reprints.xhtml
The online version of this article, along with updated information and services, is located on
the World Wide Web at:
http://pediatrics.aappublications.org/content/93/4/641
Pediatrics is the official journal of the American Academy of Pediatrics. A monthly publication, it has
been published continuously since 1948. Pediatrics is owned, published, and trademarked by the
American Academy of Pediatrics, 141 Northwest Point Boulevard, Elk Grove Village, Illinois, 60007.
Copyright © 1994 by the American Academy of Pediatrics. All rights reserved. Print ISSN: 1073-0397.