Trial Outcomes & Findings for The Effect of Local Anesthesia on Control of Intraoperative Physiologic Parameters and Post Operative Comfort (NCT NCT04500158)

Last Updated: 2024-09-19

Results Overview

The Parent's Postoperative Pain Measure ( abbreviated: PPPM) Scale consists of 15 questions with scores ranging from 0 to 15, with one point assigned to each question answered with a "Yes" and therefore higher scores indicating worse postoperative pain. A score of 6 or greater is considered clinically significant pain which was tallied for the primary outcome measure (i..e number of participants experiencing clinically significant postoperative pain).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

59 participants

Primary outcome timeframe

in the evening of the day of surgery, up to 10 hours

Results posted on

2024-09-19

Participant Flow

Participant milestones

Participant milestones
Measure	Local Anesthesia Participants will receive local anesthesia in addition to the standard care general anesthesia Lidocaine: 2% Lidocaine with 1:100,000 epi	Standard Care Participants will receive standard care general anesthesia
Overall Study STARTED	32	27
Overall Study COMPLETED	15	16
Overall Study NOT COMPLETED	17	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Local Anesthesia Participants will receive local anesthesia in addition to the standard care general anesthesia Lidocaine: 2% Lidocaine with 1:100,000 epi	Standard Care Participants will receive standard care general anesthesia
Overall Study Physician Decision	17	11

Baseline Characteristics

The Effect of Local Anesthesia on Control of Intraoperative Physiologic Parameters and Post Operative Comfort

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Local Anesthesia n=15 Participants Participants will receive local anesthesia in addition to the standard care general anesthesia Lidocaine: 2% Lidocaine with 1:100,000 epi	Standard Care n=16 Participants Participants will receive standard care general anesthesia	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=5 Participants	16 Participants n=7 Participants	31 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
Sex: Female, Male Female	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: in the evening of the day of surgery, up to 10 hours

Population: Number of parents that completed the parents post operative pain measure

Outcome measures

Outcome measures
Measure	Local Anesthesia n=15 Participants Participants will receive local anesthesia in addition to the standard care general anesthesia Lidocaine: 2% Lidocaine with 1:100,000 epi	Standard Care n=16 Participants Participants will receive standard care general anesthesia
Post Operative Pain	13 Participants	10 Participants

SECONDARY outcome

Timeframe: start of procedure to end of procedure, the intraoperative time frme

Population: Number of subjects that completed the study.

Will report the mean and standard deviation of number of teeth treated

Outcome measures

Outcome measures
Measure	Local Anesthesia n=15 Participants Participants will receive local anesthesia in addition to the standard care general anesthesia Lidocaine: 2% Lidocaine with 1:100,000 epi	Standard Care n=16 Participants Participants will receive standard care general anesthesia
Number of Teeth Treated	8.6 teeth treated Standard Deviation 3.4	7.4 teeth treated Standard Deviation 3.4

SECONDARY outcome

Timeframe: start of procedure to end of procedure, minutes

Population: Number of subjects that completed the study.

Will report the mean and standard deviation of the procedure time

Outcome measures

Outcome measures
Measure	Local Anesthesia n=15 Participants Participants will receive local anesthesia in addition to the standard care general anesthesia Lidocaine: 2% Lidocaine with 1:100,000 epi	Standard Care n=16 Participants Participants will receive standard care general anesthesia
Procedure Time	85.4 procedure time in minutes Standard Deviation 32.8	70.6 procedure time in minutes Standard Deviation 29

SECONDARY outcome

Timeframe: time from after procedure to through time in the post-anesthesia care unit in minutes

Population: Number of subjects that completed the study

Will report the mean and standard deviation of time after the procedure to through time in the post-anesthesia care unit

Outcome measures

Outcome measures
Measure	Local Anesthesia n=15 Participants Participants will receive local anesthesia in addition to the standard care general anesthesia Lidocaine: 2% Lidocaine with 1:100,000 epi	Standard Care n=16 Participants Participants will receive standard care general anesthesia
PACU Time	39.8 Time in minutes Standard Deviation 11.6	39.9 Time in minutes Standard Deviation 9.3

Adverse Events

Local Anesthesia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care

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

Dr. Caroline Carrico

Virginia Commonwealth University

Phone: (804) 828-8328

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place