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

NCT01542125 | Completed Phase 4 Results

• 1 other identifier: RES0002737
• Study Type: interventional
• Target: 281
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pain

Keywords

Patients aged 3 to 16 years presenting for; removal of smooth percutaneous interosseus pins; after orthopeadic surgery

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Liposomal Lidocaine group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Liposomal Lidocaine DRUG

4% Liposomal Lidocaine

Also known as: Maxilene

Liposomal Lidocaine group

Placebo DRUG

Tubes were visually identical to the Liposomal Lidocaine tubes.

Placebo Group

Eligibility Criteria

• Age: 3 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

MeSH Terms

Conditions

Pain

Interventions

Maxilene

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Research Coordinator
• Organization: Alberta Health Services

manu.saraswat@albertahealthservices.ca

780-492-2398

Study Officials

• Sukhdeep Dulai, FRCSC

  University of Alberta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: March 2, 2012
• Study Start: September 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: July 12, 2016
• Results First Posted: May 23, 2016

Record last verified: 2016-06