Trial Outcomes & Findings for Recovery After Total Intravenous Anesthesia With Ketofol Versus Mixture of Ketofol and Lidocaine for Short Pediatric Surgery (NCT NCT04467424)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

200 participants

Primary outcome timeframe

up to 600 seconds

Results posted on

2021-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Pediatric Anesthesia With Ketofol ketamine, propofol ketamine, propofol: anesthesia with ketofol in pediatric surgery	Pediatric Anesthesia With Ketofol Plus Lidocaine ketamine, propofol, lidocaine ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery
Overall Study STARTED	100	100
Overall Study COMPLETED	100	100
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	Pediatric Anesthesia With Ketofol n=100 Participants ketamine, propofol ketamine, propofol: anesthesia with ketofol in pediatric surgery	Pediatric Anesthesia With Ketofol Plus Lidocaine n=100 Participants ketamine, propofol, lidocaine ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	100 Participants n=100 Participants	100 Participants n=100 Participants	200 Participants n=200 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=100 Participants	0 Participants n=100 Participants	0 Participants n=200 Participants
Age, Categorical >=65 years	0 Participants n=100 Participants	0 Participants n=100 Participants	0 Participants n=200 Participants
Sex: Female, Male Female	22 Participants n=100 Participants	19 Participants n=100 Participants	41 Participants n=200 Participants
Sex: Female, Male Male	78 Participants n=100 Participants	81 Participants n=100 Participants	159 Participants n=200 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Croatia	100 participants n=100 Participants	100 participants n=100 Participants	200 participants n=200 Participants
sevoflurane for iv cannula	64 Participants n=100 Participants	54 Participants n=100 Participants	118 Participants n=200 Participants

PRIMARY outcome

Timeframe: up to 600 seconds

Population: age 1-12, male and female, pediatric short surgery

Outcome measures

Outcome measures
Measure	Pediatric Anesthesia With Ketofol n=100 Participants ketamine, propofol ketamine, propofol: anesthesia with ketofol in pediatric surgery	Pediatric Anesthesia With Ketofol Plus Lidocaine n=100 Participants ketamine, propofol, lidocaine ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Extubation Time in Children	240 second Interval 120.0 to 340.0	120 second Interval 41.5 to 170.0

PRIMARY outcome

Timeframe: up to 40 minutes

Population: Age 1-12 years, male and female, pediatric short surgery

Outcome measures

Outcome measures
Measure	Pediatric Anesthesia With Ketofol n=100 Participants ketamine, propofol ketamine, propofol: anesthesia with ketofol in pediatric surgery	Pediatric Anesthesia With Ketofol Plus Lidocaine n=100 Participants ketamine, propofol, lidocaine ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Length of Stay in the PACU	35 minute Interval 30.0 to 40.0	20 minute Interval 20.0 to 25.0

SECONDARY outcome

Timeframe: up to 60 minutes

Population: Age 1-12 years, male and female, pediatric short surgery

Outcome measures

Outcome measures
Measure	Pediatric Anesthesia With Ketofol n=100 Participants ketamine, propofol ketamine, propofol: anesthesia with ketofol in pediatric surgery	Pediatric Anesthesia With Ketofol Plus Lidocaine n=100 Participants ketamine, propofol, lidocaine ketamine, propofol, lidocaine: anesthesia with ketofol plus lidocaine in pediatric surgery
Effect of TIVA With Ketofol and Ketofol Plus Lidocaine on Total Opioid Consumption	2.3 microgram per kg Interval 2.0 to 3.0	2.1 microgram per kg Interval 2.0 to 2.8

Adverse Events

Pediatric Anesthesia With Ketofol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pediatric Anesthesia With Ketofol Plus Lidocaine

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. Ana Nevescanin Biliskov, pediatric anesthesiologist

University Hospital of Split

Phone: 00385912508001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place