The Effect of Liposomal Lidocaine on Perceived Pain in Children During Percutaneous Interosseous Pin Removal in the Outpatient Setting

The Effect of Liposomal Lidocaine on Perceived Pain in Children During Percutaneous Interosseous Pin Removal in the Outpatient Setting: A Triple Blinded, Randomized Placebo-controlled Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Liposomal Lidocaine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 281
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liposomal Lidocaine group; Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing	Drug: Liposomal Lidocaine; 4% Liposomal Lidocaine; Other Names: Maxilene
Placebo Comparator: Placebo Group; This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.	Drug: Placebo; Tubes were visually identical to the Liposomal Lidocaine tubes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	A horizontal 100 mm anchored Visual Analogue Scale (0 = no pain, 100 = worst possible pain) was used by the adult caregiver and the orthopedic technician to document the pain associated with Perc Pin removal for participant children. The Oucher Scale was used to assess pain intensity in participant children and included two separate scales. 6 photographs were assigned scores of 0, 20, 40, 60, 80, and 100 (in increasing increments of pain), such that these would be the scores averaged for participants unable to count by number. Children able to count to 100 by ones or tens and who could identify the larger of 2 numbers used the second scale; a vertical numeric one (0-100) that was printed next to the faces.	Before the application of Liposomal Lidocaine and immediately after Pin Perc removal, approximately 30 minutes

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Sukhdeep Dulai, FRCSC, University of Alberta

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: February 29, 2012
• First Posted (Estimate): March 2, 2012

Study Record Updates

• Last Update Posted (Estimate): July 12, 2016
• Last Update Submitted That Met QC Criteria: June 10, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: Patients aged 3 to 16 years presenting for; removal of smooth percutaneous interosseus pins; after orthopeadic surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: RES0002737