A Phase 4 interventional study of Liposomal Lidocaine and Placebo in Pain, sponsored by University of Alberta. Completed. Open to participants aged 3 Years to 16 Years. Per ClinicalTrials.gov, last updated 2016-07-12.
Sponsored by University of Alberta · Phase 4, Interventional, and Treatment
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.
University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
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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
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
4% Liposomal Lidocaine
Also known as: Maxilene
Tubes were visually identical to the Liposomal Lidocaine tubes.
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.
Time frame: Before the application of Liposomal Lidocaine and immediately after Pin Perc removal, approximately 30 minutes
| Milestone | Liposomal Lidocaine Group | Placebo Group |
|---|---|---|
| Started | 140 | 141 |
| Completed | 140 | 141 |
| Not completed | 0 | 0 |
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.
| units on a scale | Liposomal Lidocaine Group | Placebo Group |
|---|---|---|
| Pre-Pin Removal - Children, Oucher - Mean in mm | 0.70 ± 1.36 | 0.88 ± 1.9 |
| Pre-Pin Removal - Parent, VAS - Mean in mm | 1.04 ± 1.63 | 0.87 ± 1.46 |
| Pre-Pin Removal - Orthopedic Tec, VAS - Mean in mm | 0.27 ± 0.62 | 0.38 ± 0.92 |
| Post-Pin Removal - Children, Oucher - Mean in mm | 3.03 ± 2.69 | 2.93 ± 2.94 |
| Post-Pin Removal - Parent, VAS - Mean in mm | 3 ± 2.52 | 3.1 ± 2.60 |
| Pos-Pin Removal - Orthopedic Tec, VAS - Mean in mm | 2.09 ± 1.93 | 2.06 ± 2.04 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Liposomal Lidocaine Group | — | 0/140 (0%) | 0/140 (0%) |
| Placebo Group | — | 0/141 (0%) | 0/141 (0%) |
| Age, Continuous(years) | Liposomal Lidocaine Group | Placebo Group | Total |
|---|---|---|---|
| Mean | 7.89 ± 3.71 | 7.74 ± 3.74 | 7.81 ± 3.71 |
| Sex: Female, Male(Participants) | Liposomal Lidocaine Group | Placebo Group | Total |
|---|---|---|---|
| Female | 60 | 63 | 123 |
| Male | 80 | 78 | 158 |
No study locations are listed for this record.
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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University of Alberta