Trial Outcomes & Findings for The Effect of Liposomal Lidocaine on Perceived Pain in Children During Percutaneous Interosseous Pin Removal in the Outpatient Setting (NCT NCT01542125)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

281 participants

Primary outcome timeframe

Before the application of Liposomal Lidocaine and immediately after Pin Perc removal, approximately 30 minutes

Results posted on

2016-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	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	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.
Overall Study STARTED	140	141
Overall Study COMPLETED	140	141
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Liposomal Lidocaine on Perceived Pain in Children During Percutaneous Interosseous Pin Removal in the Outpatient Setting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Liposomal Lidocaine Group n=140 Participants 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	Placebo Group n=141 Participants 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 n=281 Participants Total of all reporting groups
Age, Continuous	7.89 years STANDARD_DEVIATION 3.71 • n=5 Participants	7.74 years STANDARD_DEVIATION 3.74 • n=7 Participants	7.81 years STANDARD_DEVIATION 3.71 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	63 Participants n=7 Participants	123 Participants n=5 Participants
Sex: Female, Male Male	80 Participants n=5 Participants	78 Participants n=7 Participants	158 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Liposomal Lidocaine Group n=140 Participants 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	Placebo Group n=141 Participants 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.
Pain Pre-Pin Removal - Children, Oucher - Mean in mm	0.70 units on a scale Standard Deviation 1.36	0.88 units on a scale Standard Deviation 1.9
Pain Pre-Pin Removal - Parent, VAS - Mean in mm	1.04 units on a scale Standard Deviation 1.63	0.87 units on a scale Standard Deviation 1.46
Pain Pre-Pin Removal - Orthopedic Tec, VAS - Mean in mm	0.27 units on a scale Standard Deviation 0.62	0.38 units on a scale Standard Deviation 0.92
Pain Post-Pin Removal - Children, Oucher - Mean in mm	3.03 units on a scale Standard Deviation 2.69	2.93 units on a scale Standard Deviation 2.94
Pain Post-Pin Removal - Parent, VAS - Mean in mm	3 units on a scale Standard Deviation 2.52	3.1 units on a scale Standard Deviation 2.60
Pain Pos-Pin Removal - Orthopedic Tec, VAS - Mean in mm	2.09 units on a scale Standard Deviation 1.93	2.06 units on a scale Standard Deviation 2.04

Adverse Events

Liposomal Lidocaine Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Coordinator

Alberta Health Services

Phone: 780-492-2398

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place