Trial Outcomes & Findings for Pharmacokinetics of Lidocaine in Healthy Adults (NCT NCT03310970)

NCT ID: NCT03310970

Last Updated: 2021-11-01

Results Overview

Cmax is the highest lidocaine concentration measured in the serum.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.

Results posted on

2021-11-01

Participant Flow

Recruitment was conducted at the University of Iowa by advertisements in the "Noon News", a UIHC newsletter, and by a mass email that was sent to all staff/faculty/and students. Recruitment began in March 2018 and continued until the enrollment goal was reached in October 2019.

Participant milestones

Participant milestones
Measure	Group 1: Generic Lidocaine Patches First, IV Lidocaine Second, the Lidoderm(R) Topical Patches Last Each subject in this group received study interventions in the following order: Each subject first wore three generic 5% (Mylan Pharmaceuticals, 140mg) lidocaine patches for 12 hours, followed by a minimum washout period of 24 hours. Each subject then received a single intravenous dose of 0.5 mg/kg lidocaine hydrochloride, followed by a minimum washout period of 24 hours. Each subject then wore three lidoderm(R) 5% (Endo Pharmaceuticals, 700mg) lidocaine patches for 12 hours.	Group 2: Lidoderm(R) Topical Patches First, IV Lidocaine Second, Then Generic Lidocaine Patches Last Each subject in this group received study interventions in the following order: Each subject first wore three lidoderm(R) 5% (Endo Pharmaceuticals, 700mg) lidocaine patches for 12 hours, followed by a minimum washout period of 24 hours. Each subject then received a single intravenous dose of 0.5 mg/kg lidocaine hydrochloride, followed by a minimum washout period of 24 hours. Each subject then wore three generic 5% (Mylan Pharmaceuticals, 140mg) lidocaine patches for 12 hours.
Overall Study STARTED	11	12
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Generic Lidocaine Patches First, IV Lidocaine Second, the Lidoderm(R) Topical Patches Last Each subject in this group received study interventions in the following order: Each subject first wore three generic 5% (Mylan Pharmaceuticals, 140mg) lidocaine patches for 12 hours, followed by a minimum washout period of 24 hours. Each subject then received a single intravenous dose of 0.5 mg/kg lidocaine hydrochloride, followed by a minimum washout period of 24 hours. Each subject then wore three lidoderm(R) 5% (Endo Pharmaceuticals, 700mg) lidocaine patches for 12 hours.	Group 2: Lidoderm(R) Topical Patches First, IV Lidocaine Second, Then Generic Lidocaine Patches Last Each subject in this group received study interventions in the following order: Each subject first wore three lidoderm(R) 5% (Endo Pharmaceuticals, 700mg) lidocaine patches for 12 hours, followed by a minimum washout period of 24 hours. Each subject then received a single intravenous dose of 0.5 mg/kg lidocaine hydrochloride, followed by a minimum washout period of 24 hours. Each subject then wore three generic 5% (Mylan Pharmaceuticals, 140mg) lidocaine patches for 12 hours.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Pharmacokinetics of Lidocaine in Healthy Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=23 Participants All study participants received IV lidocaine, generic lidocaine patches, and Lidoderm patches.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	23.9 years STANDARD_DEVIATION 6.1 • n=93 Participants
Sex: Female, Male Female	17 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Race/Ethnicity, Customized White	20 Participants n=93 Participants
Race/Ethnicity, Customized Asian	2 Participants n=93 Participants
Race/Ethnicity, Customized Hispanic/Latino	1 Participants n=93 Participants
Body mass index	23.7 kg/m^2 STANDARD_DEVIATION 2.9 • n=93 Participants

PRIMARY outcome

Timeframe: For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 27, 30, 33, 36, 39, 48 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.

Cmax is the highest lidocaine concentration measured in the serum.

Outcome measures

Outcome measures
Measure	All Study Participants n=22 Participants All subjects analyzed received and completed the following interventions: Each of the subjects wore three lidocaine 5% (Mylan Pharmaceuticals) patches for 12 hours. Each of the subjects wore three lidoderm® 5% (Endo Pharmaceuticals) topical patches for 12 hours. Each of the subjects received a single intravenous 0.5 mg/kg dose of lidocaine hydrochloride.
Measurement of Maximum Serum Concentration of Lidocaine (Cmax) Lidocaine 5% patch	113.95 ng/ml Standard Deviation 38.84
Measurement of Maximum Serum Concentration of Lidocaine (Cmax) Lidoderm® 5% patch	123.54 ng/ml Standard Deviation 68.97
Measurement of Maximum Serum Concentration of Lidocaine (Cmax) Intravenous lidocaine hydrochloride	706.15 ng/ml Standard Deviation 338.86

SECONDARY outcome

Volume of distribution is a mathematical concept that relates the amount of lidocaine in the body to the concentration of lidocaine measured in the serum.

Outcome measures

Outcome measures
Measure	All Study Participants n=22 Participants All subjects analyzed received and completed the following interventions: Each of the subjects wore three lidocaine 5% (Mylan Pharmaceuticals) patches for 12 hours. Each of the subjects wore three lidoderm® 5% (Endo Pharmaceuticals) topical patches for 12 hours. Each of the subjects received a single intravenous 0.5 mg/kg dose of lidocaine hydrochloride.
Measurement of Volume of Lidocaine Distribution (V) Lidocaine 5% patch	5.13 L/kg Standard Deviation 2.07
Measurement of Volume of Lidocaine Distribution (V) Lidoderm® 5% patch	5.15 L/kg Standard Deviation 2.13
Measurement of Volume of Lidocaine Distribution (V) Intravenous lidocaine hydrochloride	1.98 L/kg Standard Deviation 0.68

SECONDARY outcome

Tmax is the time point at which the maximum drug concentration in serum is measured.

Outcome measures

Outcome measures
Measure	All Study Participants n=22 Participants All subjects analyzed received and completed the following interventions: Each of the subjects wore three lidocaine 5% (Mylan Pharmaceuticals) patches for 12 hours. Each of the subjects wore three lidoderm® 5% (Endo Pharmaceuticals) topical patches for 12 hours. Each of the subjects received a single intravenous 0.5 mg/kg dose of lidocaine hydrochloride.
Measurement of Time of Maximum Serum Lidocaine Concentration (Tmax). Lidocaine 5% patch	9.08 hours Standard Deviation 2.90
Measurement of Time of Maximum Serum Lidocaine Concentration (Tmax). Lidoderm® 5% patch	10.82 hours Standard Deviation 2.2
Measurement of Time of Maximum Serum Lidocaine Concentration (Tmax). Intravenous lidocaine hydrochloride	0.03 hours Standard Deviation 0

SECONDARY outcome

The elimination rate constant is a mathematical value describing the rate at which lidocaine is removed from the body.

Outcome measures

Outcome measures
Measure	All Study Participants n=22 Participants All subjects analyzed received and completed the following interventions: Each of the subjects wore three lidocaine 5% (Mylan Pharmaceuticals) patches for 12 hours. Each of the subjects wore three lidoderm® 5% (Endo Pharmaceuticals) topical patches for 12 hours. Each of the subjects received a single intravenous 0.5 mg/kg dose of lidocaine hydrochloride.
Measurement of Elimination Rate Constant of Lidocaine (Kel) Lidocaine 5% patch	0.17 1/hr Standard Deviation 0.06
Measurement of Elimination Rate Constant of Lidocaine (Kel) Lidoderm® 5% patch	0.19 1/hr Standard Deviation 0.12
Measurement of Elimination Rate Constant of Lidocaine (Kel) Intravenous lidocaine hydrochloride	0.31 1/hr Standard Deviation 0.1

SECONDARY outcome

Timeframe: For both patch arms measured at time points: 1, 2, 3, 4, 5, 6, 8, 10, 12 hours. For intravenous lidocaine hydrochloride arm measured at time points: 2, 5, 10, 20, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 10 hours.

Area under the serum-concentration-time curve is a mathematical measure of total systemic exposure to lidocaine in the body.

Outcome measures

Outcome measures
Measure	All Study Participants n=22 Participants All subjects analyzed received and completed the following interventions: Each of the subjects wore three lidocaine 5% (Mylan Pharmaceuticals) patches for 12 hours. Each of the subjects wore three lidoderm® 5% (Endo Pharmaceuticals) topical patches for 12 hours. Each of the subjects received a single intravenous 0.5 mg/kg dose of lidocaine hydrochloride.
Determination of Area Under the Serum-concentration-time Curve (AUC) Lidocaine 5% patch	807.32 ng*h/ml Standard Deviation 285.31
Determination of Area Under the Serum-concentration-time Curve (AUC) Lidoderm® 5% patch	748.55 ng*h/ml Standard Deviation 420.93
Determination of Area Under the Serum-concentration-time Curve (AUC) Intravenous lidocaine hydrochloride	671.07 ng*h/ml Standard Deviation 165.01

SECONDARY outcome

Timeframe: Measured after patches are removed from subjects following 12 hours of patch wear.

The amount of drug remaining in the patches is measured after the patches have been worn and removed. This outcome is only reported for the patch arms of the study and is not applicable to the intravenous arm.

Outcome measures

Outcome measures
Measure	All Study Participants n=22 Participants All subjects analyzed received and completed the following interventions: Each of the subjects wore three lidocaine 5% (Mylan Pharmaceuticals) patches for 12 hours. Each of the subjects wore three lidoderm® 5% (Endo Pharmaceuticals) topical patches for 12 hours. Each of the subjects received a single intravenous 0.5 mg/kg dose of lidocaine hydrochloride.
Residual Drug Analysis in Worn TDDS and Patches Lidocaine 5% patch	123.79 mg Standard Deviation 6.58
Residual Drug Analysis in Worn TDDS and Patches Lidoderm® 5% patch	655.16 mg Standard Deviation 29.96

Adverse Events

Lidocaine Patch

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Lidoderm ® Topical Patch

Serious events: 0 serious events

Other events: 19 other events

Deaths: 0 deaths

Intravenous Lidocaine

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Lidocaine Patch n=22 participants at risk Each subject will wear three generic lidocaine patches for 12 hours.	Lidoderm ® Topical Patch n=23 participants at risk Each subject will wear three Lidoderm® topical patches for 12 hours.	Intravenous Lidocaine n=23 participants at risk A single intravenous dose of 0.5 mg/kg lidocaine hydrochloride will be administered to each subject.
General disorders Headache	4.5% 1/22 • Number of events 1 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	8.7% 2/23 • Number of events 5 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	8.7% 2/23 • Number of events 5 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.
Respiratory, thoracic and mediastinal disorders Increased Respiratory Rate	68.2% 15/22 • Number of events 34 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	56.5% 13/23 • Number of events 21 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	56.5% 13/23 • Number of events 50 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.
Respiratory, thoracic and mediastinal disorders Increased Heart Rate	4.5% 1/22 • Number of events 1 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	13.0% 3/23 • Number of events 5 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	4.3% 1/23 • Number of events 1 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.
Respiratory, thoracic and mediastinal disorders Decreased Heart Rate	27.3% 6/22 • Number of events 11 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	34.8% 8/23 • Number of events 16 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	13.0% 3/23 • Number of events 5 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.
General disorders Itchy lower back after patch removal	4.5% 1/22 • Number of events 1 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	0.00% 0/23 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	0.00% 0/23 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.
Respiratory, thoracic and mediastinal disorders Decreased Blood Pressure	4.5% 1/22 • Number of events 1 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	4.3% 1/23 • Number of events 1 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	8.7% 2/23 • Number of events 2 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.
Respiratory, thoracic and mediastinal disorders Increased Blood Pressure	9.1% 2/22 • Number of events 6 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	8.7% 2/23 • Number of events 3 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	13.0% 3/23 • Number of events 3 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.
General disorders Lightheadedness	0.00% 0/22 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	4.3% 1/23 • Number of events 1 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	4.3% 1/23 • Number of events 1 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.
Ear and labyrinth disorders Abnormal Hearing	0.00% 0/22 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	0.00% 0/23 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	8.7% 2/23 • Number of events 2 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.
General disorders Drowsiness/Sleepiness	0.00% 0/22 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	0.00% 0/23 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	4.3% 1/23 • Number of events 1 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.
Gastrointestinal disorders Nausea	0.00% 0/22 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	4.3% 1/23 • Number of events 1 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	0.00% 0/23 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.
Gastrointestinal disorders Heartburn	4.5% 1/22 • Number of events 1 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	0.00% 0/23 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	0.00% 0/23 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.
Skin and subcutaneous tissue disorders Contact erythema from IV placement	0.00% 0/22 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	4.3% 1/23 • Number of events 1 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.	0.00% 0/23 • Adverse Events were recorded from the date of consent, during study intervention and washout (12 days), and for 2 days of follow-up after study procedures were completed (14 days total). Adverse Events were collected based on subject reporting of events. While not all 23 participants were included in the data assessment, Adverse events were recorded for all 23 study participants. While all participants completed all three arms of the study, 1 participant withdrew after completing the Intravenous Lidocaine and Lidoderm Topical Patch Arm, leaving only 22 participants to be analyzed in the lidocaine patch arm.

Additional Information

Nicole Brogden, Associate Professor

University of Iowa

Phone: 319-335-8752

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place