Trial Outcomes & Findings for Lidocaine Patches Prior to Intravenous Insertion (NCT NCT00552695)

NCT ID: NCT00552695

Last Updated: 2012-10-22

Results Overview

Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 45 participants
• Primary outcome timeframe: 0 MINUTES
• Results posted on: 2012-10-22

Participant Flow

Participant milestones

Measure	LIDODERM Patch Lidocaine 70 mg/tetracaine 70 mg skin patch	Control Patch Warm patch with no active substances
Overall Study STARTED	22	23
Overall Study COMPLETED	22	23
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lidocaine Patches Prior to Intravenous Insertion

Baseline characteristics by cohort

Measure	LIDODERM Patch n=22 Participants Lidocaine 70 mg/tetracaine 70 mg skin patch	Control Patch n=23 Participants Warm patch with no active substances	Total n=45 Participants Total of all reporting groups
Age, Categorical <=18 years	22 Participants n=5 Participants	23 Participants n=7 Participants	45 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	9.3 years STANDARD_DEVIATION 4.3 • n=5 Participants	10.8 years STANDARD_DEVIATION 4.5 • n=7 Participants	10 years STANDARD_DEVIATION 4.3 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	23 participants n=7 Participants	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 MINUTES

Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain).

Outcome measures

Measure	LIDODERM Patch n=22 Participants Lidocaine 70 mg/tetracaine 70 mg skin patch	Control Patch n=23 Participants Warm patch with no active substances
Pain on Visual Analog Scale (VAS)	18 mm Interval 1.0 to 40.0	35 mm Interval 20.0 to 59.0

SECONDARY outcome

Timeframe: After first attempt of catheter insertion

Percentage of patients in whom intravenous catheter was inserted successfully

Outcome measures

Measure	LIDODERM Patch n=22 Participants Lidocaine 70 mg/tetracaine 70 mg skin patch	Control Patch n=23 Participants Warm patch with no active substances
Success of Intravenous (IV) Insertion	18 Percentage of participants	17 Percentage of participants

Adverse Events

LIDODERM Patch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Patch

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

Adam Singer

Stony Brook U

Phone: 631-444-7857

Email: adam.singer@stonybrook.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place