Researched by: Ms. Jillianne M. Bertiz BSN2009 A1a SCT

Pain management for newborn circumcisionPediatric 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.

BackgroundIn 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).

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

Researched by: Ms. Jillianne M. Bertiz BSN2009 A1a SCT

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.

MethodAs 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?* 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.

Researched by: Ms. Jillianne M. Bertiz BSN2009 A1a SCT

The newborn circumcision sites were routinely checked after the procedure at 15-, 30-, and 60-minute intervals for signs of bleeding, edema, and pain.

SettingThe 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.

ResultsThere 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. 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

Researched by: Ms. Jillianne M. Bertiz BSN2009 A1a SCT

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.

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 AnalgesicDuring the Circumcision at Times 1 and 2

During DuringType 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/sucroseELA-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

Researched by: Ms. Jillianne M. Bertiz BSN2009 A1a SCT

(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 DuringTime 1 and During Time 2 (N= 132)

During Time 1

Analgesia Type MeanComparison Group Difference t Sig. of t

None vs. D, DES, DS, E, RE, S 2.43 2.91 0.004R vs. RS 2.24 2.91 0.004S vs. DS 3.45 4.10 0.0001S vs. D, DES, DS, E, R, RS 1.85 2.84 0.005E vs. R 0.26 0.21 0.834D vs. R 1.69 1.43 0.155D vs. E 1.43 1.00 0.320

During Time 2

Analgesia Type MeanComparison Group Difference t Sig. of t

None vs. D, DES, DS, E, RE, S 3.05 3.38 0.001R vs. RS 2.97 1.51 0.080S vs. DS 2.97 3.70 0.001S vs. D, DES, DS, E, R, RS 2.17 3.48 0.001E vs. R 0.92 0.78 0.439D vs. R 1.92 1.70 0.092D 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 blockand ELA-Max; RS = Ring block and sucrose; S = Sucrose