Pain
Conditions
Keywords
Patients aged 3 to 16 years presenting for, removal of smooth percutaneous interosseus pins, after orthopeadic surgery
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.
Interventions
DRUGPlacebo
Tubes were visually identical to the Liposomal Lidocaine tubes.
4% Liposomal Lidocaine
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain | Before the application of Liposomal Lidocaine and immediately after Pin Perc removal, approximately 30 minutes | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Liposomal Lidocaine: 4% Liposomal Lidocaine | 140 |
| 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.
Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes. | 141 |
| Total | 281 |
Baseline characteristics
| Characteristic | Liposomal Lidocaine Group | Placebo Group | Total |
|---|---|---|---|
| Age, Continuous | 7.89 years STANDARD_DEVIATION 3.71 | 7.74 years STANDARD_DEVIATION 3.74 | 7.81 years STANDARD_DEVIATION 3.71 |
| Sex: Female, Male Female | 60 Participants | 63 Participants | 123 Participants |
| Sex: Female, Male Male | 80 Participants | 78 Participants | 158 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 140 | 0 / 141 |
| serious Total, serious adverse events | 0 / 140 | 0 / 141 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Liposomal Lidocaine Group | Pain | Pre-Pin Removal - Children, Oucher - Mean in mm | 0.70 units on a scale | Standard Deviation 1.36 |
| Liposomal Lidocaine Group | Pain | Pre-Pin Removal - Parent, VAS - Mean in mm | 1.04 units on a scale | Standard Deviation 1.63 |
| Liposomal Lidocaine Group | Pain | Pre-Pin Removal - Orthopedic Tec, VAS - Mean in mm | 0.27 units on a scale | Standard Deviation 0.62 |
| Liposomal Lidocaine Group | Pain | Post-Pin Removal - Children, Oucher - Mean in mm | 3.03 units on a scale | Standard Deviation 2.69 |
| Liposomal Lidocaine Group | Pain | Post-Pin Removal - Parent, VAS - Mean in mm | 3 units on a scale | Standard Deviation 2.52 |
| Liposomal Lidocaine Group | Pain | Pos-Pin Removal - Orthopedic Tec, VAS - Mean in mm | 2.09 units on a scale | Standard Deviation 1.93 |
| Placebo Group | Pain | Post-Pin Removal - Parent, VAS - Mean in mm | 3.1 units on a scale | Standard Deviation 2.6 |
| Placebo Group | Pain | Pre-Pin Removal - Children, Oucher - Mean in mm | 0.88 units on a scale | Standard Deviation 1.9 |
| Placebo Group | Pain | Post-Pin Removal - Children, Oucher - Mean in mm | 2.93 units on a scale | Standard Deviation 2.94 |
| Placebo Group | Pain | Pre-Pin Removal - Parent, VAS - Mean in mm | 0.87 units on a scale | Standard Deviation 1.46 |
| Placebo Group | Pain | Pos-Pin Removal - Orthopedic Tec, VAS - Mean in mm | 2.06 units on a scale | Standard Deviation 2.04 |
| Placebo Group | Pain | Pre-Pin Removal - Orthopedic Tec, VAS - Mean in mm | 0.38 units on a scale | Standard Deviation 0.92 |