Trial Outcomes & Findings for The Effect of Pretreatment With Intravenous Lidocaine for Intravenous Contrast: (NCT NCT05143489)

Results Overview

We will use a combination of the Baker-Wong FACES pain scale and 1 to 10 numerical scale for pain as well as a 5-point Likert scale for discomfort. Both scales range from no pain to very severe pain with 5 being moderate pain.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

3 participants

Primary outcome timeframe

15 minutes

Results posted on

2025-05-18

Participant Flow

Participant milestones

Participant milestones
Measure	Preservative Free Lidocaine Group The patient will receive a 1mg/kg IV dose of preservative free lidocaine with a max dose of 40mg Preservative Free Lidocaine: The patient will receive a 1mg/kg IV dose of lidocaine with a max dose of 40mg.	Placebo Group The patient will receive IV normal saline of 1mg/kg with a max of 40mg Saline: The patient will receive IV normal saline of 1mg/kg with a max of 40mg
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preservative Free Lidocaine Group n=1 Participants The patient will receive a 1mg/kg IV dose of preservative free lidocaine with a max dose of 40mg Preservative Free Lidocaine: The patient will receive a 1mg/kg IV dose of lidocaine with a max dose of 40mg.	Placebo Group n=2 Participants The patient will receive IV normal saline of 1mg/kg with a max of 40mg Saline: The patient will receive IV normal saline of 1mg/kg with a max of 40mg	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=1 Participants	2 Participants n=2 Participants	3 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Age, Categorical >=65 years	0 Participants n=1 Participants	0 Participants n=2 Participants	0 Participants n=3 Participants
Sex: Female, Male Female	0 Participants n=1 Participants	1 Participants n=2 Participants	1 Participants n=3 Participants
Sex: Female, Male Male	1 Participants n=1 Participants	1 Participants n=2 Participants	2 Participants n=3 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	1 participants n=1 Participants	2 participants n=2 Participants	3 participants n=3 Participants

PRIMARY outcome

Timeframe: 15 minutes

We will use a combination of the Baker-Wong FACES pain scale and 1 to 10 numerical scale for pain as well as a 5-point Likert scale for discomfort. Both scales range from no pain to very severe pain with 5 being moderate pain.

Outcome measures

Outcome measures
Measure	Preservative Free Lidocaine Group n=1 Participants The patient will receive a 1mg/kg IV dose of preservative free lidocaine with a max dose of 40mg Preservative Free Lidocaine: The patient will receive a 1mg/kg IV dose of lidocaine with a max dose of 40mg.	Placebo Group n=2 Participants The patient will receive IV normal saline of 1mg/kg with a max of 40mg Saline: The patient will receive IV normal saline of 1mg/kg with a max of 40mg
Pain Score at 15 Minutes Post Medication Administration	0 score on a scale Standard Deviation 0	0 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: 30 minutes

We will use a combination of the Baker-Wong FACES pain scale and 1 to 10 numerical scale for pain as well as a 5-point Likert scale for discomfort. Both scales range from no pain to very severe pain with 5 being moderate pain.

Outcome measures

Outcome measures
Measure	Preservative Free Lidocaine Group n=1 Participants The patient will receive a 1mg/kg IV dose of preservative free lidocaine with a max dose of 40mg Preservative Free Lidocaine: The patient will receive a 1mg/kg IV dose of lidocaine with a max dose of 40mg.	Placebo Group n=2 Participants The patient will receive IV normal saline of 1mg/kg with a max of 40mg Saline: The patient will receive IV normal saline of 1mg/kg with a max of 40mg
Pain Score at 30 Minutes Post Medication Administration	0 score on a scale Standard Deviation 0	3.50 score on a scale Standard Deviation 4.95

SECONDARY outcome

Timeframe: 60 minutes

We will use a combination of the Baker-Wong FACES pain scale and 1 to 10 numerical scale for pain as well as a 5-point Likert scale for discomfort. Both scales range from no pain to very severe pain with 5 being moderate pain.

Outcome measures

Outcome measures
Measure	Preservative Free Lidocaine Group n=1 Participants The patient will receive a 1mg/kg IV dose of preservative free lidocaine with a max dose of 40mg Preservative Free Lidocaine: The patient will receive a 1mg/kg IV dose of lidocaine with a max dose of 40mg.	Placebo Group n=2 Participants The patient will receive IV normal saline of 1mg/kg with a max of 40mg Saline: The patient will receive IV normal saline of 1mg/kg with a max of 40mg
Pain Score at 60 Minutes Post Medication Administration	0 score on a scale Standard Deviation 0	3.0 score on a scale Standard Deviation 4.24

SECONDARY outcome

Timeframe: 90 minutes

We will use a combination of the Baker-Wong FACES pain scale and 1 to 10 numerical scale for pain as well as a 5-point Likert scale for discomfort. Both scales range from no pain to very severe pain with 5 being moderate pain.

Outcome measures

Outcome measures
Measure	Preservative Free Lidocaine Group n=1 Participants The patient will receive a 1mg/kg IV dose of preservative free lidocaine with a max dose of 40mg Preservative Free Lidocaine: The patient will receive a 1mg/kg IV dose of lidocaine with a max dose of 40mg.	Placebo Group n=2 Participants The patient will receive IV normal saline of 1mg/kg with a max of 40mg Saline: The patient will receive IV normal saline of 1mg/kg with a max of 40mg
Pain Score at 90 Minutes Post Medication Administration	0 score on a scale Standard Deviation 0	2 score on a scale Standard Deviation 2.83

SECONDARY outcome

Timeframe: 120 minutes

We will use a combination of the Baker-Wong FACES pain scale and 1 to 10 numerical scale for pain as well as a 5-point Likert scale for discomfort. Both scales range from no pain to very severe pain with 5 being moderate pain.

Outcome measures

Outcome measures
Measure	Preservative Free Lidocaine Group n=1 Participants The patient will receive a 1mg/kg IV dose of preservative free lidocaine with a max dose of 40mg Preservative Free Lidocaine: The patient will receive a 1mg/kg IV dose of lidocaine with a max dose of 40mg.	Placebo Group n=2 Participants The patient will receive IV normal saline of 1mg/kg with a max of 40mg Saline: The patient will receive IV normal saline of 1mg/kg with a max of 40mg
Pain Score at 120 Minutes Post Medication Administration	0 score on a scale Standard Deviation 0	4 score on a scale Standard Deviation 5.66

Adverse Events

Preservative Free 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

Director of Research Administraton

Maimonides Medical Center

Phone: 7182836896

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place