Trial Outcomes & Findings for Decreasing Propofol Injection Pain by Pre-Treatment With Lidocaine in Pediatric Procedural Sedation (NCT NCT02512783)

Results Overview

The FLACC scale measures pain in children aged 2m-7y. The scale ranges from 0-10 with 0 being no pain. The total score out of 10 is based on 5 pieces of criteria, and each criteria is scored as either 0, 1, or 2. Scores on individual criteria are summed up to give a total score. Higher values represent a worse outcome of more pain. FLACC scores will be compared pre- and post-propofol induction to assess the change in FLACC score for each arm.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

171 participants

Primary outcome timeframe

1 minute before propofol induction compared to 1 minute following propofol induction

Results posted on

2016-07-21

Participant Flow

Participant milestones

Participant milestones
Measure	Lidocaine Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction. Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation Propofol: Intravenous administration of propofol according to standard care to sedate patient.	Normal Saline Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction. Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation Propofol: Intravenous administration of propofol according to standard care to sedate patient.
Overall Study STARTED	96	75
Overall Study COMPLETED	96	75
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Decreasing Propofol Injection Pain by Pre-Treatment With Lidocaine in Pediatric Procedural Sedation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine n=96 Participants Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction. Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation Propofol: Intravenous administration of propofol according to standard care to sedate patient.	Normal Saline n=75 Participants Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction. Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation Propofol: Intravenous administration of propofol according to standard care to sedate patient.	Total n=171 Participants Total of all reporting groups
Age, Categorical <=18 years	96 Participants n=5 Participants	75 Participants n=7 Participants	171 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	40 Participants n=5 Participants	35 Participants n=7 Participants	75 Participants n=5 Participants
Sex: Female, Male Male	56 Participants n=5 Participants	40 Participants n=7 Participants	96 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 minute before propofol induction compared to 1 minute following propofol induction

The FLACC scale measures pain in children aged 2m-7y. The scale ranges from 0-10 with 0 being no pain. The total score out of 10 is based on 5 pieces of criteria, and each criteria is scored as either 0, 1, or 2. Scores on individual criteria are summed up to give a total score. Higher values represent a worse outcome of more pain. FLACC scores will be compared pre- and post-propofol induction to assess the change in FLACC score for each arm.

Outcome measures

Outcome measures
Measure	Lidocaine n=96 Participants Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction. Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation Propofol: Intravenous administration of propofol according to standard care to sedate patient.	Normal Saline n=75 Participants Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction. Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation Propofol: Intravenous administration of propofol according to standard care to sedate patient.
Change in FLACC (Face, Legs, Activity, Cry, Consolability) Score	.82 units on a scale Standard Deviation 2.357	2.43 units on a scale Standard Deviation 3.268

SECONDARY outcome

Timeframe: Immediately following propofol injection

Population: This data was not collected.

Outcome measures

Outcome data not reported

Adverse Events

Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline

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

Angela Doucette

Children's Hospitals and Clinics of Minnesota

Phone: 6128137144

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place