Published online September 30, 2005
PEDIATRICS Vol. 116 No. 4 October 2005, pp. 917-920 (doi:10.1542/peds.2005-0103)
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Does Lidocaine Gel Alleviate the Pain of Bladder Catheterization in Young Children? A Randomized, Controlled Trial

Maureen Vaughan, MD*, Elizabeth A. Paton, RN, MSN, CS, NP-C*, Andrew Bush, PhD{ddagger} and Jay Pershad, MD*

* Department of Pediatrics, Division of Emergency Medicine
{ddagger} Department of Preventive Medicine, University of Tennessee Health Sciences Center, Le Bonheur Children's Medical Center, Memphis, Tennessee


   ABSTRACT
TOP
 ABSTRACT
METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
Objective. Bladder catheterization (BC) is a commonly performed, painful procedure in the pediatric emergency department (ED). A survey demonstrated that analgesia is infrequently used for several brief painful procedures, including BC, in pediatric patients. In this study, we evaluated the use of 2% lidocaine gel to alleviate the pain associated with BC in young children (<2 years) in the ED.

Methods. We conducted a randomized, double-blind, placebo-controlled trial comparing pain scores during bladder catheterization with 2% lidocaine gel versus nonanesthetic lubricant. We used a previously validated scale for measuring brief procedure-related pain in preverbal children (Face Legs Arms Cry Consolability Pain Scale [FLACC]). A total of 115 patients were recruited; 56 patients were randomized to the control group, and 59 were randomized to the lidocaine group. Lubricant was applied to both the genital mucosa and the catheter. Pain measurements were recorded at 3 time intervals: before insertion of the catheter, during catheterization, and after catheterization. Interobserver reliability had been previously established in an observational pilot study.

Results. The difference in mean FLACC scores between the control (7.55 ± 2.56) and study groups (7.37 ± 2.87) during catheterization was not statistically significant. The change in FLACC from time 1 (preprocedure) to time 2 (during procedure) was statistically significant in both groups, suggesting that bladder catheterization is a painful procedure.

Conclusions. Altering the standard practice of use of nonanesthetic lubricant with 2% lidocaine gel as lubricant during bladder catheterization in young children may not be helpful in alleviating the pain associated with the procedure.

Key Words: pain management • Lidocaine gel • bladder catheterization • FLACC

Abbreviations: ED, emergency department • BC, bladder catheterization • FLACC, Face, Legs, Arms, Cry, Consolability Pain Scale

Many brief yet painful procedures are performed on children in the emergency department (ED) and other areas of the hospital every day. A survey of PICUs and NICUs suggested that analgesia is infrequently used for several procedures, including venipuncture (2%), intravenous cannulation (10%), suprapubic bladder aspiration (8%), and urinary bladder catheterization (BC; 2%).1 We also conducted an informal telephonic and electronic survey of pediatric providers both within the United States and in other countries. The use of anesthetic gel as lubricant during BC for routine diagnostic urine sampling is an infrequent practice and not part of the standard of care in most institutions. There are a few dedicated pediatric facilities in the Midwest where 2% lidocaine gel is being used to facilitate pediatric urologic procedures, including BC.2 In pediatric centers in the United Kingdom and Australia, lignocaine gel was being used to facilitate voiding cystourethrograms in the radiology suite.

BC is a commonly performed painful procedure in the pediatric ED. Children experience a moderate amount of pain and distress during this procedure.3, 4 Because bag specimens are subject to external contamination and yield higher rates of false-positive urine cultures, it is customary to obtain diagnostic urine samples via BC.5 This is especially so in the preverbal or less verbal child, who may not be toilet trained. Any measure undertaken to alleviate the pain or anxiety of BC would be helpful.

Topical lidocaine, as a component in several preparations, is commonly used to reduce the pain associated with repair of mucosal lacerations.6, 7 In prospective studies among adult patients who underwent elective urologic procedures, topical lidocaine applied to the genital mucosa was an effective analgesic, with a rapid onset of action, averaging 2.7 minutes.8 There is paucity of data in pediatrics on the effectiveness of lidocaine during BC.2 In a prospective trial, conducted in the pediatric urology clinic, of 20 children who were between the ages of 4 and 11 years and were scheduled to have a urethral catheter inserted for a cystograms, patients were randomized to receive sterile chlorhexidine jelly or 2% lidocaine gel as lubricant. Self-rated pain scores and observer-rated behavioral distress were significantly lower in the lidocaine group than in the placebo group.2 We are not aware of any previous studies that have evaluated the effect of topical lidocaine in reducing the pain experienced during BC in the preverbal pediatric population.

The current standard of care during BC in our ED is to use nonanesthetic lubricating gel. The purpose of our study was to evaluate the effectiveness of 2% lidocaine gel in alleviating the pain and discomfort of BC in young children.


   METHODS
TOP
 ABSTRACT
 METHODS
RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 
We conducted a randomized, double-blind, placebo-controlled trial over 7 months (July 2003 to January 2004), comparing 2% lidocaine gel with conventional nonanesthetic lubricant (Lubri-gel; Major Pharmaceuticals, Livonia, MI) during BC in children who were younger than 2 years. A total of 115 patients were recruited from a convenience sample of patients who underwent a diagnostic BC in our ED (Fig 1).


Figure 1
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  		Fig 1. Study flow diagram.

 
The study was set in an urban tertiary care pediatric facility with an annual ED census of 75000. Our institutional review board approved the study. We excluded patients with an allergy to lidocaine, those with an altered mental status, unstable patients with polytrauma, and toilet-trained children.

One of the 2 investigators (M.V. or B.P.) recruited patients and obtained informed consent from parents. Patients were randomized using a computer-generated randomization table into 1 of 2 groups. The randomization sequence was maintained in a sealed envelope in our pharmacy department. The lubricant (2% lidocaine gel or nonanesthetic lubricant gel) was provided in numbered, colorless, 3-mL syringes. Patients were recruited sequentially in numeric order. BC was performed using sterile precautions as per standard nursing protocol. Approximately 1 to 2 mL of gel was applied to the genital mucosa for 2 to 3 minutes before catheterization. The remainder of the gel was used as lubricant on the catheter itself. Sterile preparation with povidone iodine (Betadine) solution was performed before catheter insertion. Sterility was maintained at all times with care taken to ensure that the tip of the syringe did not come in contact with either the genitals or the catheter.

Procedure-related pain was measured using the Face, Legs, Activity, Cry, Consolability Pain Scale (FLACC).9 This is a previously validated scale for measurement of brief procedural pain in preverbal and cognitively impaired children.10–13 FLACC records the occurrence of 5 behaviors during the medical procedure. The intensity of the behaviors are rated on a scale from 0 to 2 in which 2 indicates maximal anxiety or pain (Table 1). The maximum and minimum possible scores are 10 and 0, respectively. A score of ≤2 is generally considered to indicate absence of pain behavior.14


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  		TABLE 1. FLACC: Behavioral Scale for Rating Pain-Related Behavior in Children

 
Scores were recorded at 3 intervals. Time 1 was when the patient was placed in lithotomy position during sterile preparation phase, after gel had been applied to the genital mucosa but before catheter insertion. Time 2 was during insertion of the catheter. Time 3 was 3 to 5 minutes after the procedure, when the patient was in the caregiver's arms (Table 2). We had initially conducted a prospective observational pilot study of 57 observations on 19 consecutive eligible patients to help to identify the degree of change in the FLACC that may be considered significant and to distinguish preprocedure anxiety-related behaviors from procedural pain. Interobserver reliability of the FLACC during BC was also measured. The mean FLACC scores during the 3 measurement phases were 5.9 (±3.5), 8.8 (±1.6), and 1.6 (±1.9), respectively. Using repeated measurement analysis of variance, the difference in mean score obtained between times 1 and 2 was statistically significant (P = .0001). Interrater reliability, intraclass coefficient (2,1) was high (95% confidence interval: 0.93–0.99 during time 1, 0.95–0.99 during time 2, and 0.92–0.99 at time 3).15


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  		TABLE 2. Procedure

 
Our null hypothesis was that there was no difference in the mean FLACC scores during the catheterization phase (time 2) between the control and study groups. A priori sample size of 112 was based on the anticipated effect size of 1 point on the FLACC between the 2 groups, at an {alpha} of .05 and power of 90%.


   RESULTS
TOP
 ABSTRACT
 METHODS
 RESULTS
DISCUSSION
 CONCLUSION
 REFERENCES
 
The 2 groups were similar with respect to age, gender, preprocedure pain scores, number of positive urine cultures, and traumatic urine samples (Table 3) . A positive urine culture was defined as 1 or 2 differentiated organisms isolated on culture at a concentration of 103 or greater colony-forming units/mL. A traumatic BC was defined as >5 red cells/high-power field on microscopic examination. The Wilcoxon rank sum test was used to compare scores obtained on the FLACC. The difference in the mean scores between the control and study groups during the procedure was not statistically significant (Table 4).


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  		TABLE 3. Baseline Characteristics of the Two Groups

 

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  		TABLE 4. Comparison of Means and 95% Confidence Intervals Around the Mean, Using the FLACC During BC (Time 2) and After the Procedure (Time 3)

 
Using the Wilcoxon signed rank test, the change in the score on the FLACC from time 1 (preprocedure) to time 2 (during procedure) was determined to be statistically significant in both groups (Table 5). This was also consistent with results obtained in our pilot study, suggesting that BC is a painful procedure. Moreover, pain-related behaviors might be distinguished from non–pain-related (preprocedure anxiety) behaviors using the FLACC (Fig 2).


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  		TABLE 5. Comparison of Mean Change in Scores From Time 1 to Time 2 and from Time 2 to Time 3 in the Two Groups

 

Figure 2
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  		Fig 2. Means of pain values versus time by treatment group. y axis, pain score using FLACC (range: 0–10); x axis, times 1, 2, and 3 representing preprocedure, during BC, and after procedure.

 

   DISCUSSION
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
CONCLUSION
 REFERENCES
 
Our results suggest that altering the standard practice of using lidocaine gel instead of nonanesthetic lubricant during BC in young children may not be helpful in alleviating the pain during the procedure. However, BC seems to be a painful procedure. Non–pain-related behaviors could be distinguished from procedure-related pain using the FLACC. We are not aware of any previous data addressing the measurement of pain during BC in young children <2 years of age.

There are several limitations to our study. Our study population was a convenience sample of patients, and potentially eligible patients were not enrolled. We have no reason to suspect that patients in the ED at times when the investigators were not available would have been different from the study population. Moreover, the 2 study groups were similar in age, gender, preprocedure pain scores, proportion of traumatic urine samples, and positive urine cultures.

Another limitation was that we had nursing personnel of varying experience performing the BC. Because standard nursing protocols for BC are followed at our institution, we do not believe that this would have confounded our results. In addition, there was no difference in the incidence of traumatic catheterizations or false-positive urine cultures between the 2 groups.

For ensuring maximal effectiveness of analgesia in boys, instilling lidocaine into the penile urethra may have been more effective. This was not usual nursing policy at our institution. Moreover, the added discomfort to the patient would have confounded our scores. Although waiting longer than 2 to 3 minutes may have enhanced the analgesic effect of lidocaine gel, we had to weigh this against holding the young child in lithotomy position after application of the lidocaine gel to the periurethral area to prevent the gel from being displaced from the perineum.

It may be argued that for ensuring accurate measurement of time from application of the lubricant to catheterization, a video recording of the entire procedure with independent review of pain behaviors would have been ideal. However, given the anatomic area of the body involved, we had anticipated difficulty in obtaining caregiver consent to conduct the study.

There exists the potential for lidocaine toxicity in the doses used for BC in young infants. Before selection of the dose in our protocol, we reviewed the literature on systemic toxicity from topical application of lidocaine. On the basis of results from studies performed in adult and pediatric patients using topical (mucosal) application of lidocaine-based preparations, it was apparent that measured serum lidocaine levels were well below the toxic range.16–20 This was also true when lidocaine was applied to the inflamed mucosa of pediatric bone marrow transplant patients with oral mucositis.18 Moreover, in an adult urologic study, instillation of 400 mg of intravesical lidocaine for >60 minutes produced serum levels that were 30 times less than the toxic range.17 This is explained by the relatively resistant nature of the transitional epithelium of the genital tract to systemic absorption of lidocaine. We selected a volume of 1 to 2 mL of 2% lidocaine gel to permit adequate lubrication and analgesia during catheter insertion. The total dose of lidocaine per kilogram of body weight would be necessary to keep in mind, especially in a young infant or in patients with an inflamed mucosa or delayed hepatic clearance.

We evaluated 115 patients in our study. On the basis of prestudy estimates, this sample size was large enough to exclude the possibility of a type II error. Although it is possible that smaller differences between the lidocaine and control groups would have become apparent with a larger sample size, it is unlikely that these differences would have been clinically meaningful. Also, these differences may not be extrapolated to the non-ED setting.


   CONCLUSION
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
REFERENCES
 
BC in young children is a painful procedure. The pain experienced can be assessed objectively using the FLACC. Substituting lidocaine gel for conventional nonanesthetic lubricant during BC may not be helpful in alleviating the procedure pain and discomfort.


   ACKNOWLEDGMENTS
 
This study was supported by a Le Bonheur Children's Medical Center "Small Grant."

We thank the nursing staff of our ED without whom this work would not have been possible.


   FOOTNOTES
 
Accepted Jan 18, 2005.

Reprint requests to (J.P.) Division of Pediatric Emergency Medicine, Le Bonheur Children's Medical Center, 50 N Dunlap St, Memphis, TN 38103. E-mail: pershadj{at}lebonheur.org

No conflict of interest declared.


   REFERENCES
TOP
 ABSTRACT
 METHODS
 RESULTS
 DISCUSSION
 CONCLUSION
 REFERENCES
 

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  4. Elder JS, Longenecker R. Premedication with oral midazolam for voiding cystourethrography in children: safety and efficacy. AJR Am J Roentgenol. 1995;164 :1229 –1232[Abstract/Free Full Text]
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  7. Pode D, Zylber-Katz E, Shapiro A. Intravesical lidocaine: topical anesthesia for bladder mucosal biopsies. J Urol. 1992;148 :795 –796[ISI][Medline]
  8. van der Burght M, Schonemann NK, Laursen JK, Arendt-Nielsen L, Bjerring P. Onset and duration of hypoalgesia following application of lidocaine spray on genital mucosa. Acta Obstet Gynecol Scand. 1994;73 :809 –811[ISI][Medline]
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PEDIATRICS (ISSN 1098-4275). ©2005 by the American Academy of Pediatrics



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