The Effect of Liposomal Lidocaine on Perceived Pain in Children During Percutaneous Interosseous Pin Removal in the Outpatient Setting
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 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|
- 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.
|Study Start Date:||September 2008|
|Study Completion Date:||February 2011|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
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.
Tubes were visually identical to the Liposomal Lidocaine tubes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542125
|Principal Investigator:||Sukhdeep Dulai, FRCSC||University of Alberta|