The Effect of Liposomal Lidocaine on Perceived Pain in Children During Percutaneous Interosseous Pin Removal in the Outpatient Setting
Condition: Pain
Intervention: Liposomal Lidocaine; Placebo
Intervention description: 4% Liposomal Lidocaine; Tubes were visually identical to the Liposomal Lidocaine tubes.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 281.0
Sex: All
Minimum age: 3 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Patients aged 3 to 16 years presenting for; removal of smooth percutaneous interosseus pins; after orthopeadic surgery

Summary:

      The removal of smooth, percutaneous pins (Perc Pins), which are used for fracture fixation,
      occurs once adequate bone healing has taken place. At the Stollery Children's Hospital (SCH),
      this frequently performed procedure is currently done without anesthetic, making it a painful
      and uncomfortable experience for the child and their caregiver(s). Liposomal Lidocaine is a
      relatively new effective and "needle-free" topical anesthetic. The investigators were
      interested in examining its effectiveness in pain reduction in children undergoing Perc Pin
      removal. Objective: To determine if Liposomal Lidocaine is effective in reducing pain in a
      pediatric population undergoing Perc Pin removal compared to a placebo. Hypothesis: The
      investigators hypothesize that Liposomal Lidocaine would significantly reduce pain during
      Perc Pin removal compared to a placebo. Research Design: This was a triple-blinded,
      randomized placebo-controlled clinical trial with 281 patients (140 patients each in the
      Maxilene and 141 in the Placebo groups). Pain measurements, using the Oucher Scale (children)
      and a 10-cm Visual Analog Scale (parents and caregivers) were collected prior to
      randomization and immediately after Perc Pin removal. Data was analyzed using a Student's
      t-test and the Wilcoxon signed ranks test.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children between 3 and 16 years of age (i.e. up to but not including the 17th
             birthday) who present to the Pediatric Plaster Room at the SCH for Perc Pin removal
             were eligible for inclusion in this study.

        Exclusion Criteria:

          -  Any patient with Perc Pins that are threaded (not smooth), as these pins require a
             more difficult removal process, oftentimes in the operating room instead of the
             orthopedic clinic.

          -  Infection around the Perc Pins: This is considered a relative contraindication to the
             use of topical anesthetic as it is usually less effective in this situation.

          -  Any parents/patients unable to exhibit understanding of the Oucher/VAS -- due to
             language barriers or developmental delay in the patient (e.g. severe cerebral palsy).

          -  The presence of an open wound in the vicinity of the pins that could not be excluded
             from the area to which the topical anesthetic cream is to be applied.

          -  Present use of analgesic or anxiolytic medications (within 24 hours prior to pin
             removal)

          -  Known allergies or adverse reactions to Maxilene