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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
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Liposomal Lidocaine
Drug: Placebo
Enrollment 281
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Liposomal Lidocaine Group Placebo Group
Hide Arm/Group Description

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

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.

Period Title: Overall Study
Started 140 141
Completed 140 141
Not Completed 0 0
Arm/Group Title Liposomal Lidocaine Group Placebo Group Total
Hide Arm/Group Description

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

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.

Total of all reporting groups
Overall Number of Baseline Participants 140 141 281
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 140 participants 141 participants 281 participants
7.89  (3.71) 7.74  (3.74) 7.81  (3.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 141 participants 281 participants
Female
60
  42.9%
63
  44.7%
123
  43.8%
Male
80
  57.1%
78
  55.3%
158
  56.2%
1.Primary Outcome
Title Pain
Hide Description

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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liposomal Lidocaine Group Placebo Group
Hide Arm/Group Description:

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

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.

Overall Number of Participants Analyzed 140 141
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liposomal Lidocaine Group Placebo Group
Hide Arm/Group Description

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

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.

All-Cause Mortality
Liposomal Lidocaine Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Liposomal Lidocaine Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/140 (0.00%)   0/141 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Liposomal Lidocaine Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/140 (0.00%)   0/141 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Research Coordinator
Organization: Alberta Health Services
Phone: 780-492-2398
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT01542125     History of Changes
Other Study ID Numbers: RES0002737
First Submitted: December 15, 2011
First Posted: March 2, 2012
Results First Submitted: June 5, 2015
Results First Posted: May 23, 2016
Last Update Posted: July 12, 2016