Lidocaine Lubricant in Pediatric Urethral Catheterization
Condition: Fevers; Pain
Study type: Interventional

Summary: 
      In Emergency Departments (ED) across the nation there is renewed interest in finding ways to
      alleviate the pain and discomfort associated with many of the procedures that children must
      undergo. In a policy by the American Academy of Pediatrics, a nationally recognized advocate
      for children, physicians are urged to advocate for child-specific research in pain management
      and the effective use of pain medication to ensure compassionate and competent management of
      pain. (AAP Statement, 2001) Pediatric urethral catheterizations are one such procedure in
      which children experience significant pain.(11) In present care, children over 2 months of
      age do not routinely receive intervention for urethral catheterization related anxiety and
      pain, and, anecdotal reports suggest that most require physical restraint to complete the
      procedure. Lidocaine is an anesthetic agent that provides relief from pain during many
      commonly performed ED procedures. Intraurethral Lidocaine has been shown to decrease pain
      associated with urethral catheter placement in cystograms, however, Lidocaine is not
      routinely used for urethral catheterizations in the CHOA ED.

      This study aims to investigate the potential use of Lidocaine as an anesthetic agent during
      urethral catheterization of children. Recently, two specific studies were performed
      investigating the use of Lidocaine to decrease discomfort associated with urethral
      catheterization. Using the strengths of both previously published studies, our study will use
      Lidocaine both topically and instilled into the urethra. Investigators plan to perform a
      prospective three-arm double-blinded randomized clinical trial investigating the
      effectiveness of Lidocaine jelly as a analgesic when used as a lubricant for urinary
      catheterization. Investigators aim to demonstrate that Lidocaine used as a lubricant
      anesthetic for urethral catheterization will provide a safe, time-efficient, and relatively
      easy way to decrease pediatric pain in the emergency department setting.
    

Detailed description: 
      In Emergency Departments (ED) across the nation there is renewed interest in finding ways to
      alleviate the pain and discomfort associated with many of the procedures that children must
      undergo. Children's memory and reaction to negative experiences in the care of medical
      professionals has led to many changes in procedural pain management (4). One noxious
      procedure that continues to be performed in the ED without the use of anesthetic agents is
      urethral catheterization (11). In a policy by the American Academy of Pediatrics, a
      nationally recognized advocate for children, physicians are urged to advocate for
      child-specific research in pain management and the effective use of pain medication to ensure
      compassionate and competent management of pain. (AAP Statement, 2001)

      Pediatric urethral catheterizations are one such procedure in which children experience
      significant pain. (11) The Children's Healthcare of Atlanta (CHOA) ED at Egleston performs an
      average of greater than 150 pediatric urethral catheterizations per month. This procedure is
      performed in most cases where children under 6 months of age present with unexplained fever.
      Also, divisional guidelines call for urethral catheterization for urinanalysis and urine
      culture on all uncircumcised boys under the age of 1 and all girls under the age of 2 who
      present with unexplained temperature above 39.5 degrees. In a previous Friends funded
      clinical trial, ED investigators studied sucrose use in children under 2 months of age which
      was shown to decrease urethral catheterization discomfort. As such, this has become routine
      care in the ED. (REF; for a review of sucrose for pediatric pain, see 6) In present care,
      children over 2 months of age do not routinely receive intervention for urethral
      catheterization related anxiety and pain, and, anecdotal reports suggest that most require
      physical restraint to complete the procedure.

      Lidocaine is an anesthetic agent that provides relief from pain during many commonly
      performed ED procedures. Examples of present Lidocaine use in the ED are laceration repair,
      abscess drainage, and lumbar puncture. Given the anxiety, discomfort, and pain associated
      with urethral catheterizations (1, 2, 3, 4), Lidocaine has begun to be used clinically in
      this arena. Intraurethral Lidocaine has been shown to decrease pain associated with urethral
      catheter placement in cystograms, however, Lidocaine is not routinely used for catheter
      placement to obtain urine in the CHOA ED.

      Recently, two specific studies were performed investigating the use of Lidocaine to decrease
      discomfort associated with urethral catheterization. The first published study supports the
      use of intraurethral Lidocaine for catheterization.(5) In this investigation, Lidocaine was
      repeatedly instilled into the urethra of ten 4- to 11-year-old patients for approximately 10
      minutes prior to a scheduled cystogram. Patients in this study indicated significantly less
      pain with Lidocaine as a lubricant when compared to those who received sterile lubricant
      jelly. However, the placement of a catheter for cystogram requires the catheter to be in
      place for the duration of the procedure (10 to 15 minutes); whereas catheterization in the ED
      for urinalysis and urine culture requires catheter placement for a much shorter period of
      time. The second study, which compared Lidocaine to lubricant jelly used as a topical
      anesthetic prior to catheterization, found that preverbal patients experienced the same
      discomfort with or without Lidocaine when evaluated using
      Face-Legs-Activity-Cry-Consolability (FLACC) scoring.(11) Authors attempted to investigate
      Lidocaine topically placed at the urethral meatus to provide relief. Although the
      investigators did not achieve their goal of pain reduction using Lidocaine topically, they
      did find that the incidence of positive urine culture was similar in both the Lidocaine and
      placebo groups. Using the strengths of both previously published studies, our study will use
      Lidocaine both topically and instilled into the urethra.

      Medical care professionals are increasing their attention to pain and comfort measures for
      children undergoing painful procedures in the ED. Pediatric urethral catheterization is one
      such area that remains unaddressed. The use of Lidocaine as an anesthetic in common ED
      procedures is well known. Investigation of Lidocaine use as an anesthetic lubricant has been
      reported twice previously in pediatric literature with contradicting results. After critical
      appraisal of these studies, our investigators conclude that additional investigation is
      warranted with the following characteristics: Lidocaine should be placed both topically and
      instilled into the urethra; Lidocaine should be compared to both routine care and placebo;
      methodology should include blinded observations; methodology should evaluate pain response
      utilizing numerous validated tools; and urine should be monitored to evaluate the biological
      effects of Lidocaine on urine culture results. Investigators aim to demonstrate that
      Lidocaine used as a lubricant anesthetic for urethral catheterization will provide a safe,
      time-efficient, and relatively easy way to decrease pediatric pain in the emergency
      department setting.

      Specific Aims & Hypotheses

      SA1: To study the potential use of Lidocaine as an anesthetic agent during urethral
      catheterization of children presenting to Pediatric Emergency Department.

      H1: The use of Lidocaine jelly as a lubricant in urethral catheterizations in pediatric ED
      patients significantly decreases distress associated with this procedure.

      SA2: To determine the average Lidocaine concentration present in urine obtained with
      Lidocaine jelly used as lubricant during urinary catheterization.

      H2: Urine Lidocaine concentrations associated with routine urethral catheterization utilizing
      intraurethral Lidocaine installation will not approach known bacterial growth-limiting
      levels.
    

Intervention name(s): Lubricant Instillation; Lidocaine Lubricant
Intervention type(s): Procedure; Drug
Intervention description(s): Lubricant jelly instilled in urethra prior to catheterization; 2% Lidocaine lubricant instillation prior to urethral catheterization
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Lidocaine; Infant; Urinary Catheterization; Emergency Medicine; Analgesia