Meatotomy Using Local Anesthesia and Sedation or General Anesthesia With or Without Penile Block in Children: A Prospective Randomized Study

Meatotomy Using Local Anesthesia and Sedation or General Anesthesia With or Without Penile Block in Children: A Prospective Randomized Study

Pediatric Urology Meatotomy Using Local Anesthesia and Sedation or General Anesthesia With or Without Penile Block in Children: A Prospective Randomi...

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Pediatric Urology

Meatotomy Using Local Anesthesia and Sedation or General Anesthesia With or Without Penile Block in Children: A Prospective Randomized Study David Ben-Meir,* Pinhas M. Livne, Elad Feigin, Ranit Djerassi and Rachel Efrat From the Pediatric Urology Unit (DB-M, PML), Pain Unit (RD, RE) and Department of Pediatric Surgery (EF), Schneider Children’s Medical Center of Israel, Petach Tikva and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel Submitted for publication July 16, 2010. Study received institutional review board approval. * Correspondence: Pediatric Urology Unit, Schneider Children’s Medical Center of Israel, 14 Kaplan St., Petach Tikva 49202, Israel (telephone: 972-3-925-3347; FAX: 972-3-925-3287; e-mail: [email protected]).

Purpose: Meatotomy is a simple, common procedure for the treatment of meatal stenosis. We compared the outcomes of meatotomy performed using local anesthesia and sedation, and general anesthesia with and without penile block. Materials and Methods: A prospective comparative design was used. Participants included 76 boys 1.5 to 10 years old treated for meatal stenosis at a tertiary, university affiliated, pediatric medical center in 2008. Children were randomly allocated to undergo surgery with sedation and local anesthesia, or general anesthesia with or without penile block. All procedures were performed with the same method by the same surgeon. For local anesthesia EMLA 5% cream (lidocaine 2.5% and prilocaine 2.5%) covered with an occlusive dressing was applied 1 hour preoperatively, and midazolam (in patients younger than 5 years) or nitrous oxide (older than 5 years) was used for sedation. General anesthesia was induced with inhaled sevoflurane, and ropivacaine was used for dorsal penile nerve block. Results: There was no difference among the groups in pain level intraoperatively (no pain in 92% to 93% of patients), 24 hours postoperatively (no pain in 81% to 88%) or after 1 month, or in complication rates (bleeding in 3 patients, laryngospasm in 2). General anesthesia with penile block was associated with a trend of less dysuria. Quality of void was excellent in 87% of patients at 24 hours and in 70% at 1 month, and parental satisfaction was high (88% to 92%). Conclusions: Meatotomy performed using local anesthesia and sedation has an equally good outcome to meatotomy performed using general anesthesia with or without penile block. Key Words: anesthesia, general; anesthesia, local; conscious sedation; urogenital surgical procedures

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MEATAL stenosis is a narrowing of the opening of the urethra at the external meatus. The condition occurs in male infants after circumcision at an incidence approaching 7.3%,1 presumably due to prolonged exposure of the delicate meatus to the moist and irritating environment of the diaper, leading to ammonia dermatitis.2 Other causes are post-hypospadias repair, traumatic or prolonged urethral cath-

eterization and balanitis xerotica obliterans. Treatment consists of surgical meatotomy. At our tertiary pediatric medical center meatotomy is performed with the patient under general anesthesia with or without penile block, according to surgeon preference. However, the waiting time for this simple procedure is long because of the heavy surgical load at our hospital. Some

0022-5347/11/1852-0654/0 THE JOURNAL OF UROLOGY® © 2011 by AMERICAN UROLOGICAL ASSOCIATION EDUCATION

Vol. 185, 654-657, February 2011 Printed in U.S.A. DOI:10.1016/j.juro.2010.09.119

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RESEARCH, INC.

MEATOTOMY USING LOCAL OR GENERAL ANESTHESIA

urologists routinely perform meatotomy in the office setting using local anesthesia. The office setting is more accessible and decreases the cost of the procedure. Furthermore, many parents are concerned about the risks of general anesthesia and prefer local anesthesia. Recently 2 studies described the use of EMLA cream for meatotomy performed in the office with good results.3,4 However, in our experience using a similar protocol the procedure did not go as smoothly as reported. Some of the children or parents were too anxious to proceed with surgery using local anesthesia despite careful preparatory explanations. In addition, we could not find any research in the medical literature comparing the outcome of local and general anesthesia for meatotomy. To fill this gap, we conducted a prospective randomized study to compare the use of sedation and local anesthesia with general anesthesia with or without penile block for meatotomy. The outcome measures were pain, dysuria, use of pain medications, complications, parental satisfaction, quality of void and meatal width.

PATIENTS AND METHODS The study was approved by the institutional review board and signed informed consent was obtained from the parents. The study sample included 76 boys 1.5 to 10 years old who presented with meatal stenosis and met the indications for meatotomy, including pinpoint meatus or meatal stenosis and an upward or lateral curved urinary stream that caused difficulties in voiding directly into the toilet. Boys who refused to undergo the procedure under local anesthesia were excluded. Because of manpower limitations, the study time frame was limited to 1 year (2008). All meatotomies were performed at our institution by a single pediatric urologist using a single technique. Preoperatively patients were randomly allocated to 1 of 3 groups, ie sedation and local anesthesia (group 1), general anesthesia without penile block (group 2) and general anesthesia with penile block (group 3). Patients in group 1 who were younger than 5 years underwent sedation with midazolam (0.5 mg/kg) 30 minutes before the procedure, while those who were older than 5 years were sedated with nitrous oxide (30%) before and during the procedure. One hour before meatotomy the nurse applied a generous amount of 5% EMLA cream on the glans penis and covered it with an occlusive dressing. One of the parents was asked to sit near the patient during the procedure. The surgical field was separated from the upper trunk by a curtain. After the dressing was removed the surgical field was prepped and draped while the parent distracted the patient. The meatus was grasped with forceps to ensure that the analgesia was adequate. In group 3 after induction of anesthesia dorsal penile nerve block was performed with ropivacaine (1 mg/kg). In all groups a straight hemostat was applied for 1 minute to crush the meatal membrane, and an incision was then made along the crushed line.

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After the procedure all patients received acetaminophen per rectum (15 mg/kg, up to 500 mg). The surgeon showed the parents how to open the meatus and had them do it the first time under his supervision. They were instructed to open the meatus 3 times daily for 1 week and to apply chloramphenicol 3% ointment to the meatus twice daily.

Outcome Evaluation During the procedure patient pain levels were recorded by a single nurse based on visible signs, including no pain (no visible reaction), possible pain (signs of restlessness or movement requiring the nurse to hold the legs of the patient during the procedure) and obvious pain (crying or moaning during the procedure). Immediately after the procedure dysuria and general pain were rated by the parents using a visual analogue scale, with a score of 0 indicating no pain, 1 to 3 mild pain, 4 to 6 moderate pain and 7 to 10 severe pain. A dose of 10 mg/kg ibuprofen was administered as rescue medication in recovery. At 24 hours postoperatively parents were contacted by telephone at home and asked to evaluate several factors, including quality of void (excellent, mildly improved, improved, not improved or worse), use of rescue analgesia with acetaminophen or ibuprofen and satisfaction with the procedure (very satisfied, moderately satisfied or not satisfied). Patients were scheduled for a followup visit at the outpatient clinic 1 month postoperatively. The urologist recorded the quality of void and meatal width (widely open, partially open, restenosis).

Statistical Analysis The Wilcoxon/Kruskal-Wallis test was used to compare ordinal data, and the Fisher-Freeman-Halton test was used for analysis of categorical data.5 Statistical significance was considered at p ⬍0.05.

RESULTS Mean patient age was 4.3 years. There was no age difference among the groups. One patient was excluded after recruitment because the EMLA dressing was improperly applied. The results in the 3 groups are shown in the table. The nurse observed no pain reaction throughout the procedure in 92% of the patients in groups 1 and 2, and 96% in group 3. This difference was not statistically significant. Complications included bleeding in 2 boys in group 1 (1 required suturing) and 1 in group 3, and laryngospasm in 1 boy each in groups 2 and 3. Level of pain before discharge home did not differ significantly among the groups. A trend of less dysuria was noted in group 3 compared to the other groups. There were no significant differences among the groups regarding use of analgesic agents, quality of void or parental satisfaction at 24 hours, or in the quality of void and meatal width at 1 month postoperatively.

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MEATOTOMY USING LOCAL OR GENERAL ANESTHESIA

Meatotomy outcomes using sedation and local anesthesia or general anesthesia with or without penile block Variable

Group 1

Group 2

Group 3

p Value

Mean yrs age (range) No. intraoperative pain: None Possible pain Obvious pain No. pain before discharge home: None Mild Moderate Severe No. dysuria before discharge home: None Mild Moderate Severe No. pain at home‡ No. voiding quality at 24 hrs: Excellent Improved Not improved No. satisfaction at 24 hrs: Very satisfied Moderately satisfied Not satisfied No. voiding quality at 1 mo: Excellent Improved Not improved No. meatal width at 1 mo: Wide open Partially open Restenosis No. complications:

4.36 (1.5–10)

3.9 (2–6.5)

4.8 (1.5–10)

0.36* 0.74†

Bleeding Laryngospasm

23 2 0

23 2 0

25 1 0 0.31†

19 2 3 1

22 2 1 0

23 3 0 0 0.11†

10 4 7 3 5

11 7 4 3 4

17 6 2 1 4

23 2 0

22 2 1

21 5 0

20 2

22 1

24 2

3

2

0

18 7 0

17 7 1

18 8 0

0.86† 0.48†

0.79† 16 9 0

15 10 0

18 8 0 Not significant



— —

1

1 1

* Wilcoxon/Kruskal-Wallis test. † Fisher-Freeman-Halton test. ‡ Based on analgesic intake. § One case required suturing.

DISCUSSION The present study was prompted by 2 publications in the literature on meatotomy done using local anesthesia. Cartwright et al used topical EMLA cream in 58 patients with meatal stenosis.3 Of these patients 3 had limited discomfort because of technically inappropriate application of the cream. The authors found the outpatient procedure to be simple, successful and cost effective. However, there was no focus on pain. In a prospective study Smith and Gjellum compared the use of EMLA 5% and lido-

caine 4% creams for pain relief in 52 boys undergoing meatotomy.4 Postoperative pain was evaluated with the Wong-Baker faces score. Mean ⫾ SD immediate postoperative pain score was 3.2 ⫾ 4.7 (range 0 to 10) in the EMLA group and 1.8 ⫾ 2.6 (0 to 6) in the lidocaine 4% group. There was no shortterm followup. The results were considered excellent in all patients. In neither of these studies, nor anywhere in the literature, could we find a comparison of local vs general anesthesia for meatotomy. Circumcision is the main cause of meatal stenosis, and the defect is generally detected when the child has difficulty directing the voiding stream into the toilet. Meatal stenosis is a relatively common problem in Israel, where most inhabitants are Jewish or Muslim, and most boys are ritually circumcised. Given the reported benefits of meatotomy using local anesthesia, we attempted to adopt this method at our center, where meatotomy had traditionally been performed using general anesthesia. However, we found that this approach often turned into an unpleasant experience for the child, parents and surgeon. Some of the patients remained highly anxious and restless despite our best efforts to prevent anxiety by careful preprocedural explanations, placement of a curtain to shield the patient from the operative field and having the parent sit next to the patient during the procedure. In retrospect, this outcome was not surprising given findings that children as young as 4 years (mean age of present sample) are aware of their body image and, therefore, would be wary of any procedure performed on the penis.6 Indeed, on careful rereading of the study of Cartwright et al,3 we found that although the authors did not mention experiencing this problem, they did warn in the discussion that patient anxiety may hamper performance of meatotomy using local anesthesia. To counter anxiety, we speculated that we might still be able to perform meatotomy comfortably on an outpatient basis by adding sedation to the local anesthesia. To explore the safety and effectiveness of this method, we prospectively compared it to general anesthesia with or without penile block in a scientific study. This series yielded several important findings. Anxiety There were no procedural failures due to patient or parental anxiety when sedation with local anesthesia was used. Furthermore, patient and parental cooperation was excellent. Pain and Satisfaction There were no statistically significant differences among the groups in level of pain during the procedure (as evaluated by attending nurse), before discharge or at home (based on analgesic intake). Pa-

MEATOTOMY USING LOCAL OR GENERAL ANESTHESIA

tients treated under general anesthesia with penile block had less dysuria at discharge home but the difference did not reach statistical significance. Penile block is not recommended for pain control in meatotomy done under local anesthesia because the pain of the injection itself can cause the child to move, compromising safety. Most parents in all groups were satisfied with the procedure. There was no linear correlation between degree of pain or dysuria and degree of satisfaction. Satisfaction was apparently also influenced by other parameters such as the office room milieu and attitude of the staff. Complication Rate There was no difference in complication rates among the groups. However, most boys in the sedation plus local anesthesia group had various degrees of skin reaction (edema and blanching) to the EMLA cream. Severe blanching may have increased the risk of bleeding in the 2 boys with this complication due to either the fragility of the tissue or the difficulty in cutting precisely through the crush line made by the hemostat. As a result of this finding, in children with marked blanching in response to EMLA cream we now leave the hemostat in place for 2 to 3 minutes before performing meatotomy. Quality of Void Voiding was described as excellent or improved by nearly all parents at 24 hours and at 1 month after meatotomy. However, in nearly half of the boys (equally distributed among the 3 groups) the meatus remained partially closed. It seems that many par-

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ents were afraid to open the meatus to the end of the surgical cut, although they were individually instructed by the surgeon and practiced in front of him. We assumed that 1 month was long enough for the meatus to heal and that it would not close further. It is noteworthy that use of conscious sedation in the office setting may pose a barrier to many physicians. Ambulatory surgery centers, which have the necessary facilities and are much more flexible than hospital operating rooms, may be a good alternative. Study Limitations The limitations of this study include the relatively small number of patients in each group and the limited 1-year time frame for recruiting patients. The study also lacks a comparison of the long-term outcomes (quality of void, meatal width) of meatotomy performed using sedation with local anesthesia and general anesthesia.

CONCLUSIONS Sedation plus local anesthesia for performing meatotomy is as safe and effective as general anesthesia with or without penile block in terms of pain control, complication rate, quality of void and parental satisfaction. Local anesthesia eliminates the need for an operating room, making the procedure more widely available and more cost effective. Meatotomy under sedation with local anesthesia should be considered for most patients who require treatment for meatal stenosis.

REFERENCES 1. Van Howe RS: Incidence of meatal stenosis following neonatal circumcision in a primary care setting. Clin Pediatr (Phila) 2006; 45: 49.

3. Cartwright PC, Snow BW and McNees DC: Urethral meatotomy in the office using topical EMLA. J Urol 1996; 156: 857.

5. Bailar JC III and Hoaglin DC: Medical Uses of Statistics, 3rd ed. Hoboken, New Jersey: John Wiley & Sons 2009.

2. Cartwright PS and Snow B: Office pediatric urology. In: Clinical Pediatric Urology, 4th ed. Edited by A. B. Belman, L. R. King and S. A. Kramer. London: Martin Dunitz 2002; p 211.

4. Smith DP and Gjellum M: The efficacy of LMX versus EMLA for pain relief in boys undergoing office meatotomy. J Urol 2004; 172: 1760.

6. Cohane GH and Pope HG: Body image in boys: a review of the literature. Int J Eat Disord 2001; 29: 373.