Routine neonatal circumcision can be a painful procedure. Although analgesia for circumcision has been studied extensively, there are few studies comparing which surgical technique may be associated with the least pain and discomfort when carried out by pediatric trainees.
OBJECTIVE: We studied two commonly used techniques for circumcision to determine which was associated with less pain and discomfort.
STUDY DESIGN: In a randomized, prospective, but not blinded study, newborns were circumcised either by Mogen clamp or by PlastiBell. All received dorsal nerve blocks with lidocaine. Fifty-nine well, term, newborn infants at San Francisco General Hospital were studied from 1997 to 1998. Circumcisions were carried out mostly by interns and residents in family practice and pediatrics. Pain was assessed by measuring duration of the procedure and by a simple behavioral score done sequentially.
RESULTS: Dorsal nerve blocks were judged to be fully effective in over 70% of cases. Neither Mogen nor PlastiBell was associated with greater pain per 3-minute time period, but the PlastiBell technique on average took nearly twice as long as the Mogen procedure (20 vs 12 minutes). We judged that 60% of the infants had pain or discomfort associated with the procedure that was excessive. Residents and interns universally preferred the Mogen technique over the PlastiBell because of the former's simplicity.
CONCLUSION: During the procedure, Mogen circumcision is associated with less pain and discomfort, takes less time, and is preferred by trainees when compared with the PlastiBell.
Circumcision, one of the most commonly performed surgical procedures in the United States, is carried out because of a complex array of medical, sociocultural, and religious factors.1,2,3,4,5,6 In 1999, the American Academy of Pediatrics summarized the benefits and advantages as well as risks and disadvantages from neonatal circumcision.7 Their conclusion is that the “data are not sufficient to recommend routine neonatal circumcision.”
This study was catalyzed by our hospital's obstetric service choice not to carry out circumcisions because of their belief that it was medically unjustified.8 Pediatric staff decided to continue to provide circumcisions gratis (MediCal does not reimburse physicians for routine neonatal circumcisions) for those parents who requested it, because we assumed that the inconvenience, costs, and discomfort would be greater if the procedure were carried out after the newborn period.
Pain, discomfort, and behavioral changes are well documented during neonatal circumcision;9,10,11,12 however, there are few studies comparing methods and procedures used for circumcisions.13 In this study, we measured duration and intensity of pain with a simple behavioral scale after randomizing infants to one of two techniques — Mogen or PlastiBell. Our presumption was that the procedure of shortest duration would be the least painful granted the amount of pain per unit time was similar with each technique. Although circumcision is usually a rapid procedure in the hands of skilled operators,13 no studies have compared the amount of time required by trainees to perform different techniques.
The sample included term male infants born at San Francisco General Hospital. Inclusion criteria were:
Parental request for neonatal circumcision
Parental consent for participation in study
Term gestation (≥36 weeks' gestation)
Birth weight (≥2500 g)
No urological anomalies contraindicating circumcision, such as ambiguous genitalia or hypospadius
The human research committee of the university approved the protocol. The ethnic distribution of the newborn population was approximately: African American 14%, Asian 23%, Latino 44%, white 11%, and other 8%. The percentage of neonatal circumcisions performed annually at San Francisco General Hospital is approximately 20% of the male newborns (1500 deliveries/yr). To estimate the sample size, we used the data of Benini and coworkers14 on heart rate changes during circumcision. We assumed twice the variability that they found with a similar effect size and determined a sample size of 30 in each group for an alpha of 0.05 (two tailed) and a beta of 0.20.14 Enrolled infants were assigned to either the Mogen (Spectrum, Stow, OH) or PlastiBell (Hollister, Libertyville, IL) method by randomizing in variably sized blocks. A table of random numbers was used to generate the assignments. The assignments were placed in sealed envelopes that were numbered sequentially.
Infants were not fed for 1 to 2 hours before the procedure. After enrollment, the physician performing the circumcision opened the next envelope, and determined the procedure. A dorsal nerve block was emplaced using 0.3 ml of 1% lidocaine injected through a 27-gauge needle on each side.15,16,17 The infant was restrained on a circumcision restraint device (Circumstraint, Olympic Medical, Seattle, WA). An assistant (medical student or resident) offered a pacifier dipped in dextrose 5% to the restrained infant and recorded the infant's behavior in timed intervals during the procedure. Time of dorsal nerve block, time of first clamp on the foreskin, response to skin clamping, and average infant behavior in 3-minute epochs for the duration of the procedure were recorded. Time was measured to the nearest minute. The infants' responses to the application of the first foreskin clamp were graded by cry, with 0 to 1 indicating no or minimal response, 4 indicating a lusty bellow of rage, and 2 and 3 indicating midrange responses. This response was used to judge the adequacy of the dorsal nerve block. Thereafter, infant behaviors were graded using a scale of 1 to 7 that was adapted and simplified from other neonatal pain scores.18 A single grade, representing the average behavior, was assigned for each 3-minute period. Grade 1 was deep sleep indicated by regular breathing, eyes closed, and no eye or extremity movements. Grade 2 was rapid eye movement sleep defined by rapid eyelid movements, irregular respirations, and frequent limb movements or twitches. Grade 3, a drowsy state, was characterized by eyes mostly open and sparse body movements with some sucking. An infant who was awake and alert, with eyes occasionally fixing on objects, arms and legs moving, no cry, some sucking movements, was assigned grade 4. Grade 5 was defined by the infant being fussy with infrequent soft vocalizations, purposeful extremity movements against restraints, active head motion, and a facial expression of discontent. Grade 6 was scored for mild or moderate crying. Grade 7 was defined by continuous loud crying indicative of rage. The beginning of the circumcision was recorded as the time the first clamp was placed on the foreskin. The end of the procedure was recorded when sterile drapes were removed.
Medical students, interns, and residents were responsible for obtaining two consents from the parents — one consent for the procedure and another for participation in the study. Consent forms were written in Spanish or English, and where necessary translators were utilized. In cases where parents refused consent for randomization, circumcision was performed after dorsal nerve block using the procedure chosen by the operator. Only procedures in which consent for randomization was obtained were included in this study. We did not track or record data on those who refused circumcision or those who were not asked for enrollment in the study.
The method of performing the Mogen procedure followed the description included with the instrument (package insert, H Bronstein, Instructions for the use of the Mogen circumcision instrument). The method of performing the PlastiBell procedure also followed the directions on the package insert. We trained medical students and house staff for the techniques by routine didactic review, by providing videotapes of each procedure, and by direct supervision. All circumcisions were supervised by an attending neonatologist or an experienced senior resident. On rare occasions when the nursery was busy, the circumcision was performed by one of the four neonatologists.
Sixty-one infants were enrolled in this study over a 2-year period from 1997 to 1998. Two were eliminated, one for insufficient data and one for unclear identification of the procedure, leaving 30 in the Mogen group and 29 in the PlastiBell group included in the analysis. The time from dorsal nerve block to placing the first clamp on the foreskin was 6 minutes for the group assigned to Mogen and 5 minutes for the group assigned to PlastiBell (p>>0.05). No difference in the response to placement of the first clamp was found between the two groups (an average score of 1 for each group). The efficacy of the dorsal nerve block for all infants in the study is shown in Figure 1, with approximately 65% of the infants having a minimal (or no) response.
Figure 2 indicates that distribution of the duration for the two techniques differs. Average duration for the PlastiBell technique was 20±1.7 minutes (mean±SEM), and average duration for the Mogen technique was 12±0.9 (p<0.001). Average pain scores over 3-minute periods were identical in the two groups. They averaged between 4 and 6 (Figure 3). Overall pain was also scored for the entire procedure. Sixty one percent of the entire sample had overall pain scores of >4 with no differences between groups. We did not assess postoperative pain in this study.
We assessed the duration of the circumcision by level of training of the operator. However, we had too few patients to make meaningful comparisons (medical students carried out nine circumcisions; family practice and pediatric interns, 29; third year pediatric residents, 15; and neonatologists, 6). On nine occasions for the Mogen and seven for the PlastiBell, the procedure was the first circumcision performed by the trainee.
No major complications were encountered by either method during the course of the study (see Discussion section for a complication incurred after the study). In three instances, only the outer epidermal layer of the foreskin was removed by the Mogen, leaving the inner foreskin layer adherent to the glans. In these cases, the inner foreskin layer was removed from the glans and the time involved was included for the duration of the original procedure. Informal reports from our follow-up clinic indicated that mothers occasionally complained that their infant did not appear as if they had been circumcised (Mogen technique), and two of these infants had a repeat circumcision. We also received occasional complaints from the outpatient clinic regarding the PlastiBell technique. Issues included partial separation of the plastic ring from the penis, irregular foreskin removal, or swelling of the shaft of the penis.
After becoming familiar with both techniques, house officers and attending neonatologists universally preferred the Mogen technique because of its greater ease and because it required less time. Comments about the PlastiBell commonly included discontent with the difficulties of the technique. Comments about the Mogen indicated discomfort about blindly cutting tissue near the glans.
Circumcisions using the Mogen procedure were carried out in about 60% of the time required for PlastiBell circumcisions and because our measure of pain per time period was similar for the two procedures, we assume the overall pain of the Mogen procedure was less. Probably because of our use of dorsal nerve blocks in both groups, we found no difference in degree of pain between procedures in the first 15 minutes, that is to say, pain was related only to the efficacy of the dorsal nerve block and to the duration of the procedure. Total pain, however, is the product of amount of pain times duration and more than half of the study group had what we considered excessive pain/discomfort over the course of the entire procedure. We agree with those who attribute much of the evident discomfort (when dorsal nerve block is used effectively) to the spread-eagled restraint of extremities in extension on an unforgiving surface. Better restraint devices have been proposed.19 Another source of discontent is infant hunger, because it is traditional to carry out the procedure when the infants have not recently been fed to prevent vomiting and possible aspiration. However, we know of no evidence for this approach and no rationale other than the time-honored practice of doing elective surgery on patients who have an empty stomach.
Two circumcisions were repeated after discharge of the infant from the nursery, both after Mogen procedures, and the amount of pain incurred in the second circumcision is in addition to that of the first. Removal of too small amount of foreskin such that the infant looks uncircumcised was due to the fear of amputation of the glans if more was removed. In fact after completion of this study, approximately 10% of the glans of a newborn was amputated (it was reattached surgically) during a Mogen circumcision carried out by two of our most experienced physicians. The cause was a small adhesion near the meatus that was not lysed so that the glans was partially pulled through the Mogen clamp and removed with the foreskin. We have since modified the Mogen procedure, still in use in our nursery, by carrying out a dorsal slit of the foreskin and retracting it fully to ascertain that no adhesions remain before pulling it into the Mogen clamp for removal. This modification has also been associated with no further need for repeat circumcisions in over 200 Mogen procedures done since the modification was put in place.
Limitations of this study are several. Obviously the study was not double-blind. We had gaps in our enrollment during months when the principal investigator was not rigorously promoting adherence to the study protocol. Behavioral scoring was not done by a single observer, nor was formal interobserver reliability tested. Behavioral testing for the assessment of pain, the use of pain scores, has been cogently critiqued.20 Nonetheless, spot checking of the scoring by the senior investigator found that the method was straightforward and applied in unambiguous fashion by those using it, and scoring by the senior investigator and the person recording data was in agreement. A variety of surgical instruments are available for neonatal circumcision and this study assesses only two of them. We did not assess the esthetics of the results of the procedure or parent satisfaction. Our sample was too small to assess the relative safety of these techniques.
Advocates of circumcision and those against this procedure both mount cogent arguments to support their respective viewpoints.21,22,23 We believe more studies of the risk and benefits of circumcision are needed. Outcome measures should include acute and long-term adverse effects like cosmesis, parent satisfaction, safety, complications, long-term medical outcomes, and ultimately an assessment of the feelings of the circumcised or uncircumcised boy/adult, and possibly his sexual partner(s).24,25,26 Sample sizes in the thousands would be necessary and the cost of the study would be high. However, current annual costs of routine neonatal circumcision are ca. $150,000,000, (est. 1,000,000 males in U.S. circumcised at $150 hospital+physician costs). Problems associated with the uncircumcised state (increased risk of urinary tract infections, sexually transmitted infections, and phimosis, for example) are more difficult to estimate, but may not be insignificant.1,21 Complications of circumcision are probably underreported.27,28,29,30,31 The major benefits of this study in our institution was to identify a technique associated with less pain for the infant and to focus the attention of trainees, staff, and parents on the rationale or lack of it for carrying out the procedure.
Wiswell TE . Circumcision circumspection N Engl J Med 1997 3336: 1244–5
Gollaher D . Circumcision: A History of the World's Most Controversial Surgery New York: Basic Books 2000
Wellington N, Rieder MJ . Attitudes and practices regarding analgesia for newborn circumcisions Pediatrics 1993 92: 541–3
Lovell J . Maternal attitudes towards circumcision J Fam Pract 1979 9: 811–3
Patel D . Factors affecting the practice of circumcision Am J Dis Child 1982 136: 634–6
Grossman E, Posner N . Surgical circumcision of neonates: a history of its development Obstet Gynecol 1981 58: 241–6
Circumcision. Circumcision policy statement Pediatrics 1999 103: 686–93
Grimes D . Routine circumcision of the newborn infant: a reappraisal Am J Obstet Gynecol 1978 130: 125–9
Dixon S, Snyder J, Holve R . Behavioral effects of circumcision with and without anesthesia J Dev Behav Pediatr 1984 5: 246–50
Marshall R, Stratton W, Moore J . Circumcision I: effects on newborn behavior Infant Behav Dev 1980 3: 1–14
Anand K, Hickey P . Pain and its effects in the human neonate and fetus N Engl J Med 1987 317: 1321–9
Taddio A, Katz J, Ilersich A, Koren G . Effect of neonatal circumcision on pain response during subsequent routine vaccination Lancet 1997 349: 599–603
Kurtis PS, DeSilva HN, Bernstein BA, Malakh L, Schechter NL . A comparison of the Mogen and Gomco clamps in combination with dorsal penile nerve block in minimizing the pain of neonatal circumcision Pediatrics 1999 103: E23
Benini F, Johnston CC, Faucher D, Aranda JV . Topical anesthesia during circumcision in newborn infants JAMA 1993 270: 850–3
Kirya C, Werthmann M . Neonatal circumcision and penile dorsal nerve block — a painless procedure J Pediatr 1978 92: 998–1000
Holliday MA, Pinchert TL, Kiernan SC, Kunos I, Angelus P, Keszler M . Dorsal penile nerve block vs topical placebo for circumcision in low-birth-weight neonates Arch Pediatr Adolesc Med 1999 153: May 476–80
Fontaine P, Toffler WL . Dorsal penile nerve block for newborn circumcision Am Fam Physician 1991 43: 1327–33
Abu-Saad H, Bours H-G, Stevens B, Hamers J . Assessment of pain in the neonate Semin Perinatol 1998 22: 402–16
Stang H, Snellman L, Condon L et al. Beyond dorsal penile nerve block: a more humane circumcision Pediatrics 1997 100: E3
Barr R . Reflections on measuring pain in infants: dissociation in responsive systems and “honest signalling” Neonat Intensive Care 1998 12: 19–24
Schoen EJ, Wiswell TE, Moses S . New policy on circumcision — cause for concern Pediatrics 2000 105: 620–3
Multiple authors. Supplement on circumcision Br J Urol 1999 83: 1–109
NOHARMM. Available at http://www.noharmm.org1999
Laumann EO, Masi CM, Zuckerman EW . Circumcision in the United States: prevalence, prophylactic effects, and sexual practices JAMA 1997 277: No. 13 April 1052–7
Hammond T . A preliminary poll of men circumcised in infancy or childhood Br J Urol 1999 83: Suppl 1 85–92
O'Hara K, O'Hara J . The effect of male circumcision on the sexual enjoyment of the female partner Br J Urol 1999 83: (Suppl 1) 79–84
Kaplan G . Complications of circumcision Urol Clin North Am 1983 10: 543–9
Williams N, Kapila L . Complications of circumcision Br J Surg 1993 80: Oct 1231–6
Oskan S, Gurpinar T . A serious circumcision complication: penile shaft amputation. A new reattachment technique with a successful outcome J Urol 1997 158: 1946–7
Gluckman G, Stoller M, Jacobs M, Kogan B . Newborn penile glans amputation during circumcision and successful reattachment J Urol 1995 153: 778–9
Bliss D, Healey P, Waldhausen J . Necrotizing fasciitis after PlastiBell circumcision J Pediatr 1996 131: 459–62
The interest, support, and participation of the University of California — San Francisco pediatric house staff, medical students, and the San Francisco General Hospital Infant Care Center nursing staff was critical for the conduct of this study.
Financial support for this study was provided by the Department of Pediatrics, University of California — San Francisco.
About this article
Cite this article
Taeusch, H., Martinez, A., Partridge, J. et al. Pain During Mogen or PlastiBell Circumcision. J Perinatol 22, 214–218 (2002). https://doi.org/10.1038/sj.jp.7210653
European Journal of Pediatrics (2021)
Italian Journal of Pediatrics (2013)