The Effect of Liposomal Lidocaine on Perceived Pain in Children During Percutaneous Interosseous Pin Removal in the Outpatient Setting
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|ClinicalTrials.gov Identifier: NCT01542125|
Recruitment Status : Completed
First Posted : March 2, 2012
Results First Posted : May 23, 2016
Last Update Posted : July 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Liposomal Lidocaine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||281 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
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.
- Pain [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01542125
|Principal Investigator:||Sukhdeep Dulai, FRCSC||University of Alberta|