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Researched by: Ms. Jillianne M.

Bertiz BSN2009 A1a SCT

Pain management for newborn circumcision


Pediatric Nursing, Sept-Oct, 2004 by Ivy S. Razmus, Madelyn E. Dalton, David Wilson

Circumcision is the surgical removal of the foreskin of the glans penis. Newborns
undergoing circumcision demonstrate objective, measurable evidence of pain, yet the
procedure is often performed without analgesia. Newborn circumcision is reported to be
the most common elective surgical procedure performed on infants in the United States
(Taddio, 2001). There is still significant controversy regarding the benefits and risks of
newborn circumcision. In 1999, the American Academy of Pediatrics (AAP) issued a
policy statement indicating that newborn circumcision is not considered a medical
necessity; the AAP, therefore, does not endorse the practice of infant circumcision for
prophylactic health reasons.

In recent years a number of authors have reported medical benefits to newborn


circumcision including a decrease in the number of infant urinary tract infections
(Schoen, Colby, & Ray, 2000), reported protection against penile cancer (Schoen, Oehrli,
Colby, & Machin, 2000), protection against HIV infection (Halperin & Bailey, 1999), and
protection against transmission of human papilloma virus (HPV) (Castellsague et al.,
2002). Some have challenged the AAP to reconsider its position of not recommending
newborn circumcision based on existing data indicating more potential benefits of
circumcision, particularly later in life, than harm (Schoen, 2003). Complication rates
from newborn circumcision are reported to be approximately .20% or 1 adverse event
out of every 476 male infants circumcised (Christakis et al., 2000), and the most
commonly reported complications from the procedure include bleeding, infection,
recurrent phimosis, adhesions, and injury to the glans (Lerman & Liao, 2001).

Practices for pain management have been inconsistent for newborns, and there
are differing perceptions among health care practitioners as to whether newborns
experience pain during circumcision. Current hospital practices do not consistently
manage or minimize pain and distress during newborn circumcision. Although there are
numerous professional organizations that support use of analgesia during newborn
circumcision (AAP, 1999; American College of Obstetricians and Gynecologists, 2001;
American Society of Pain Management Nurses, 2001; Anand and International Evidence-
Based Group for Neonatal Pain, 2001), such practices have not been universal.

Background
In the last decade, there has been an increased awareness of newborn pain and
an increased emphasis on the proper management of newborn pain for procedures such
as circumcision. However, despite ample evidence indicating newborns experience pain,
there are health care workers who believe newborn circumcision is not a procedure that
requires analgesia; such beliefs embrace the misconception that newborns do not
remember the pain of circumcision and do not feel the pain (Wellington & Rieder, 1993).
There is a significant body of evidence demonstrating that newborns experience
measurable physiologic and emotional pain responses to painful procedures, including
circumcision, and further evidence that untreated newborn pain causes short and long
term behavioral changes (Anand & Hickey, 1987; Lerman & Liao, 2001; Puchalski &
Hummel, 2002; Rabinowitz & Hulbert, 1995; Taddio, 2001; Williamson, 1997).
Consequently, it is recommended that newborns receive adequate and appropriate
analgesia during painful procedures such as circumcision (American Academy of
Pediatrics and American College of Obstetricians and Gynecologists, 2002; Anand and
International Evidence-Based Group for Neonatal Pain, 2001).
Researched by: Ms. Jillianne M. Bertiz BSN2009 A1a SCT

The four main types of anesthesia/analgesia that are used with newborn
circumcision include: concentrated oral sucrose, topical anesthetic (EMLA[R] - 2%
lidocaine/2% prilocaine, or ELA-Max - 4% lidocaine), ring block, and dorsal penile nerve
block (DPNB). Various studies have found the DPNB an effective analgesic for newborn
circumcision, reducing the manifestations of pain. In yet another study, ring block alone
(subcutaneous infiltration of 1% lidocaine solution) was found to be more effective at
reducing newborn circumcision pain than DPNB, topical anesthetic (EMLA), or placebo
(no anesthetic/analegesic) (Lander, Brady-Fryer, Metcalf, Nazerali, & Muttit, 1997).
The topical anesthetic EMLA has been used to reduce pain of circumcision and was
found to be effective in studies by Taddio et al.(1997), as well as Benini, Johnston,
Faucher and Aranda (1993). At the time of this writing, there are no published studies
regarding the effectiveness of ELA-Max in newborn pain reduction.
Concentrated oral sucrose has gained recognition as a pain management
intervention with newborns during heel sticks and circumcisions. Allen, White, and
Walburn (1996) evaluated the pain responses (crying) in 1 to 2-week-old and older (2, 4,
6, 9, 15, and 18 months) infants who received 2 mL of a concentrated oral sucrose
(12%) solution before immunization. The 2-week-old infants who received either sterile
water or concentrated oral sucrose cried significantly less than the older aged infants
and those infants who received no intervention.
Some investigators (Blass & Hoffmeyer, 1991) suggested oral sucrose had
antinociceptive effects on newborns undergoing painful procedures. A concentrated oral
sucrose (24%) solution was more effective than water at reducing crying and grimacing
in newborn circumcised with a Mogen or Gomco clamp (Kaufman, Cimo, Miller, & Blass,
2002). In this study the FLACC pain scale was used to monitor the newborn's pain
during circumcision. The FLACC (chart) (Merkel, Voepel--Lewis, Shayevitz & Malviay,
1997) has five categories that include: Face (0-2), Legs (0-2), Activity (0-2), Cry (0-2)
and Consolability (0-2), which results in a combined total score of 0-10. The higher the
FLACC score, the more intense the pain. The FLACC tool was validated by the above
researchers using ANOVA for repeated measures to compare FLACC scores in this study
with a p < 0.001; pre-analgesia scores were significantly higher than post analgesia
scores at 10, 30, and 60 minutes. FLACC scores and OPS pain scores also had a
significant positive correlation r = 0.80; p < 0.001; there was also a positive correlation
between FLACC scores and nurses' ratings of pain (Merkel, Voepel-Lewis, Shayevitz, &
Malviay, 1997). Manworren and Hynan (2003) judged the FLACC scale to be clinically
appropriate for the detection and management of pain occurring as a result of an illness
or procedure in children under the age of 3 years; the results of the study also validated
pediatric nurses' clinical judgment for determining analgesic selection instead of
reliance on a pain scale alone. At our facility, physicians and nursing staff identified
inconsistencies in pain management of circumcisions performed on the newborn. A
quality improvement project was initiated to assess current pain management
practices. It was revealed that over 50% of the obstetricians and 5% of the pediatricians
used no analgesia with newborn circumcision.

Method
As part of a quality improvement process at our facility, this project was designed
to describe and measure at various time intervals, the effectiveness of
analgesics/anesthesia for newborns undergoing circumcision. Research questions
addressed by the study were as follows:
* Is there a difference between pain ratings for infants who receive analgesia during
circumcision compared with those who do not receive analgesia?
* If there is a difference in pain ratings, which type or combination of
analgesia/anesthesia has the lowest pain rating for circumcision?
Researched by: Ms. Jillianne M. Bertiz BSN2009 A1a SCT

* Each newborn to be circumcised was assessed for pain using the FLACC pain scale
before, during, and after the procedure.
Approval of the project by the institution's Institutional Research and Ethics
Board was obtained after data collection. Informed consent was not obtained prior to
data collection since the project used data from the infant's medical record. Pain ratings
are documented on every newborn circumcised as a standard part of nursing care. Each
staff nurse was educated regarding the FLACC pain scale prior to the initiation of the
data collection process, however, interrater reliability among the different staff nurses
was not established. Categories for the choices of analgesia/anesthesia were Lidocaine
Block- Ring or DPNB, Topical ELA-Max (which was currently used in this facility; EMLA
cream was no longer supplied by the hospital pharmacy at the time of the study), as
well as a commercially prepared 24% oral sucrose solution (Sweet-Ease, Children's
Medical Ventures, Norwell, MA), or any combination thereof. The FLACC table was
placed on each newborn's bedside clipboard and data entered before, during, and after
the procedure by nursing staff. The newborn circumcision sites were routinely checked
after the procedure at 15-, 30-, and 60-minute intervals for signs of bleeding, edema,
and pain.

Setting
The setting is a large, private, metropolitan medical center in the southern
Midwest area of the United States with a 30-bed Level I nursery. The medical center
delivers approximately 3,000 newborns a year.
Sample and data collection. Each male newborn to be circumcised was included
in the study during the time of data collection (N = 132). The sample consisted of term
or near-term males, regardless of ethnic origin or insurance provider. The sample
consisted of 7 American Indian, 107 Caucasian, 3 Unknown, 3 Other, 2 African
American, 3 Hispanic, and 4 Asian newborns. The average gestational age at the time of
circumcision was 38.34 weeks with a range of 35 to 41 weeks. The average age at the
time of circumcision was 2.38 days, however, when excluding the three newborns who
were circumcised at 11, 21, and 23 days, the average age at time of circumcision was
1.97 days. This project lasted 2 months in the spring of 2002.
Data analysis. An ANCOVA was used to analyze the data (p = .05). All of the
assumptions for performing this test were upheld. There were nine procedural/analgesia
groups (Dorsal Block, Dorsal Block/Sucrose, Dorsal Block/Sucrose/ELA-Max, ELA-
Max/Sucrose, Ring Block, Ring Block/Sucrose, Sucrose alone, and no analgesic). The
ANCOVA was used to analyze the differences in FLACC scores twice during the
circumcision during time one (DT1) and during time two (DT2), and 15, 30, 45, and 60
minutes following the circumcision. The FLACC score prior to the circumcision was
covaried out of all analyses.

Results
There was a significant effect of type of analgesic (p < .0001) (see Table 1). No
significant effects of analgesic emerged for the other four times. To further analyze the
data, seven planned linear contrasts were performed. Linear contrasts had to be
orthogonal, with no single contrast measuring the same item as another contrast. All
linear contrasts were performed for Times 1 and 2 but not for the remaining times
because these were not significant. The alpha level remained at .05 in accordance with
the modified Bonferroni procedure (Kipper, 1991). The Bonferroni procedure was used
to establish (through a series of t-tests) the types of analgesia that were significantly
different in their means while adjusting the significance level for multiple comparisons
at 0.05. When comparing FLACC scores of infants who received no analgesic and infants
who received any form or combination of analgesic, a significant difference emerged.
Researched by: Ms. Jillianne M. Bertiz BSN2009 A1a SCT

Newborns who received no analgesic had a higher FLACC score during the circumcision.
In addition, infants who received only oral sucrose had a higher FLACC score than those
who received any other form of analgesic during the circumcision (see Table 2).
The effects of individual groups of analgesics were also compared to each other.
Infants who received a combination of Ring Block and Sucrose had a lower FLACC score
than infants who received Ring Block alone for the first assessment during circumcision
(p < .004). In addition, infants receiving a Dorsal Block/Sucrose combination had a
significantly lower FLACC than those who received Sucrose at both circumcision times (p
< .001).
ELA-Max, Dorsal Block, and Ring Block groups were also compared to each other
individually. Infants receiving ELA-Max did not have a significantly different FLACC score
than those who received Ring Block. FLACC scores were also not significantly different
between ELA-Max and Dorsal Block groups. Dorsal Block and Ring Block also failed to
show significant differences on FLACC scores.
Discussion
The results of this study do not support other studies (Lander et al., 1997), which
found the ring block to be the most effective method of anesthesia/analgesia for
newborn circumcision. Although the ring block was one of the most effective methods in
this study, it was not the most effective method. There were no significant differences
between the ring block and the dorsal block on FLACC scores DT1. In our study, needle
size was primarily 30 gauge with an occasional 27 gauge and this could have influenced
the pain scores. Pain scores may also have been influenced by the length of time the
physician waited for the block to take effect before beginning the circumcision.
Performing the block can lead to discomfort and may account for the higher FLACC
scores that were obtained on the first assessment during circumcision. It is not clear
whether performing the block is more painful than the procedure itself with regard to
newborn circumcisions. The results from this study were consistent with Olson and
Downey's (1998) study that showed no significant difference between the DPNB and
EMLA at baseline and after the procedure, but did demonstrate a significant difference
during the procedure. On the other hand, Butler-O'Hara, LeMoine, and Guillet's (1998)
study found that DPNB provided better pain management for newborn circumcision
than did topical EMLA cream. The study by Holliday et al. (1999) did find the DPNB to be
more effective than placebo at reducing newborn circumcision pain. It is interesting to
note that physicians who performed dorsal blocks in our facility also ordered a topical
anesthetic prior to the procedure, while physicians who performed ring blocks did not.
The combination of topical ELA-Max with dorsal block had higher FLACC scores than the
dorsal block alone or the dorsal block with sucrose.
The highest FLACC scores were seen with newborns who received no
anesthesia/analgesia, while oral sucrose alone had the next highest FLACC scores,
which supports the Blass and Hoffmeyer (1991) study that found sucrose and water
were more effective than no intervention at all. The study findings also support previous
research by Taddio et al. (1997) and Benini et al. (1993) who found topical anesthetics
to be effective to reduce pain during newborn circumcision. In this study, ELA-Max
cream did not have a significantly different score than the ring block or the dorsal block.
Previous studies involving topical anesthetic in newborns have concentrated on topical
EMLA and, as of this writing, there is no study regarding the use of ELA-Max for newborn
circumcision.
The use of a quality improvement project related to infant pain assessment
during circumcision provided data that initiated a change in medical and nursing
practice in a variety of ways. The introduction of a pain assessment tool to be used
routinely by nursing staff represented a change in practice in the newborn nursery; prior
to the initiation of this project, pain assessments were not standard nursing practice.
Researched by: Ms. Jillianne M. Bertiz BSN2009 A1a SCT

The data was presented to the Newborn Peer Review Committee, a


multidisciplinary group consisting of physicians (including obstetricians and
pediatricians) and nurses. The committee recommended that the circumcision policy be
changed based on the data obtained from this project. The policy change reflected that
no newborn circumcision would be performed in the newborn nursery without the use of
analgesia, and concentrated sucrose alone would not be acceptable as the only form of
analgesia. Through strong physician support and acknowledgement of the data from
this project, policy and practice were changed within 3 months of the project initiation.
Pain assessments are now done routinely with newborn care utilizing the FLACC
pain scale. There are also reports of increased satisfaction for the nursing staff that
assist with circumcisions because newborns appear more comfortable during the
procedure.
Table 1. Mean (SD) FLACC for Each Type of Analgesic
During the Circumcision at Times 1 and 2

During During
Type Time 1 Time 2

Dorsal block 3.71 2.00


(N=7) (2.36) (2.16)
Dorsal block/sucrose 2.75 2.12
(N= 16) (2.32) (2.22)
Dorsal block/sucrose
ELA-Max 4.33 3.33
(N=3) (1.15) (2.88)
ELA-Max 5.17 3.00
(N=6) (3.71) (2.10)
ELA-Max/sucrose 5.12 3.50
(N=8) (3.14) (2.00)
Ring block 5.47 3.92
(N= 15) (2.17) (2.40)
Ring block/sucrose 3.18 2.59
(N=44) (2.56) (2.56)
Sucrose 6.14 5.10
(N= 22) (2.31) (1.92)
None 6.91 6.25
(N= 11) (3.02) (3.41)

Table 2. T-Test Results Contrasting Various Analgesia Types During


Time 1 and During Time 2 (N= 132)

During Time 1

Analgesia Type Mean


Comparison Group Difference t Sig. of t

None vs. D, DES, DS, E, RE, S 2.43 2.91 0.004


R vs. RS 2.24 2.91 0.004
S vs. DS 3.45 4.10 0.0001
S vs. D, DES, DS, E, R, RS 1.85 2.84 0.005
E vs. R 0.26 0.21 0.834
D vs. R 1.69 1.43 0.155
Researched by: Ms. Jillianne M. Bertiz BSN2009 A1a SCT

D vs. E 1.43 1.00 0.320

During Time 2

Analgesia Type Mean


Comparison Group Difference t Sig. of t

None vs. D, DES, DS, E, RE, S 3.05 3.38 0.001


R vs. RS 2.97 1.51 0.080
S vs. DS 2.97 3.70 0.001
S vs. D, DES, DS, E, R, RS 2.17 3.48 0.001
E vs. R 0.92 0.78 0.439
D vs. R 1.92 1.70 0.092
D vs. E 1.00 0.75 0.457

Note: D = Dorsal Block; DES = Dorsal Block, ELA-Max, Sucrose; DS =


Dorsal Block, Sucrose; E = ELA-Max; R = Ring block; RE = Ring block
and ELA-Max; RS = Ring block and sucrose; S = Sucrose