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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Alberta
ClinicalTrials.gov Identifier:
NCT01542125
First received: December 15, 2011
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain
 Drug: Liposomal Lidocaine
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

MedlinePlus related topics: Caregivers
U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Pain [ Time Frame: Before the application of Liposomal Lidocaine and immediately after Pin Perc removal, approximately 30 minutes ] [ Designated as safety issue: No ]

    Pain was assessed using the Visual Analogue Scale (caregivers and technician) and the Oucher Scale (children).

    The average time between the application of Liposomal Lidocaine and the removal of the pin perc was 30 minutes. Pain was assessed prior to the application of Liposomal lidocaine and immediately after the pinc perc removal.



Enrollment: 281
Study Start Date: September 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Ages Eligible for Study:   3 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542125

Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Sukhdeep Dulai, FRCSC University of Alberta
  More Information

No publications provided

Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01542125     History of Changes
Other Study ID Numbers: RES0002737
Study First Received: December 15, 2011
Last Updated: February 29, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
Patients aged 3 to 16 years presenting for
removal of smooth percutaneous interosseus pins
after orthopeadic surgery

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 13, 2013