Trial Outcomes & Findings for Effect of Monochromatic Light on Incidence of Emergence Delirium in Children (NCT NCT03285243)

NCT ID: NCT03285243

Last Updated: 2024-02-29

Results Overview

Assessment if monochromatic light reduces the absolute incidence of emergence delirium following general anesthesia (as a binary: emergence delirium vs. no emergence delirium)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 104 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2024-02-29

Participant Flow

Recruitment was performed between November 3, 2017 and June 2, 2020

Participant milestones

Measure	Blue Light - Non Monochromatic Monochromatic blue light: Exposure to monochromatic light for the first 30 minutes in the recovery period after anesthesia to assess incidence of emergence delirium as noted by the PAED scale	Monochromatic Blue Light Monochromatic blue light: Exposure to monochromatic light for the first 30 minutes in the recovery period after anesthesia to assess incidence of emergence delirium as noted by the PAED scale
Overall Study STARTED	52	52
Overall Study COMPLETED	52	51
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Monochromatic Light on Incidence of Emergence Delirium in Children

Baseline characteristics by cohort

Measure	Blue Light - Non Monochromatic n=52 Participants Monochromatic blue light: Exposure to monochromatic light for the first 30 minutes in the recovery period after anesthesia to assess incidence of emergence delirium as noted by the PAED scale	Monochromatic Blue Light n=52 Participants Monochromatic blue light: Exposure to monochromatic light for the first 30 minutes in the recovery period after anesthesia to assess incidence of emergence delirium as noted by the PAED scale	Total n=104 Participants Total of all reporting groups
Age, Categorical <=18 years	52 Participants n=93 Participants	52 Participants n=4 Participants	104 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	4.2 years STANDARD_DEVIATION 1.4 • n=93 Participants	4.7 years STANDARD_DEVIATION 1.3 • n=4 Participants	4.5 years STANDARD_DEVIATION 1.4 • n=27 Participants
Sex: Female, Male Female	24 Participants n=93 Participants	24 Participants n=4 Participants	48 Participants n=27 Participants
Sex: Female, Male Male	28 Participants n=93 Participants	28 Participants n=4 Participants	56 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	52 Participants n=93 Participants	52 Participants n=4 Participants	104 Participants n=27 Participants
Region of Enrollment United States	52 participants n=93 Participants	52 participants n=4 Participants	104 participants n=27 Participants

PRIMARY outcome

Timeframe: 30 minutes

Assessment if monochromatic light reduces the absolute incidence of emergence delirium following general anesthesia (as a binary: emergence delirium vs. no emergence delirium)

Outcome measures

Measure	Blue Light - Non Monochromatic n=52 Participants Monochromatic blue light: Exposure to monochromatic light for the first 30 minutes in the recovery period after anesthesia to assess incidence of emergence delirium as noted by the PAED scale	Monochromatic Blue Light n=52 Participants Monochromatic blue light: Exposure to monochromatic light for the first 30 minutes in the recovery period after anesthesia to assess incidence of emergence delirium as noted by the PAED scale
Number of Participants With Emergence Delirium Following Anesthesia in Children	17 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 minutes

Population: Patient had Emergence Delirium or a PAED Scale Score of 12 or more for 30 minutes after Baseline(n, %)

Assessment of Pediatric Emergence Delirium Scale (PAED) scale scores at varying points during the initial recovery phase in patients exposure to monochromatic light vs. sham Pediatric Emergence Delirium Scale scored ranges from a Minimum of 2 to a maximum of 20. Higher scores are associate with emergence delirium and agitation indicating a worse outcome

Outcome measures

Measure	Blue Light - Non Monochromatic n=52 Participants Monochromatic blue light: Exposure to monochromatic light for the first 30 minutes in the recovery period after anesthesia to assess incidence of emergence delirium as noted by the PAED scale	Monochromatic Blue Light n=52 Participants Monochromatic blue light: Exposure to monochromatic light for the first 30 minutes in the recovery period after anesthesia to assess incidence of emergence delirium as noted by the PAED scale
Number of Participants With PAED Scale Score of 12 or More for 30 Minutes After Baseline	27 Participants	12 Participants

Adverse Events

Blue Light - Non Monochromatic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Monochromatic Blue Light

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

Adam Adler

Baylor college of Medicine

Phone: 832-8245800

Email: Adam.adler@bcm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place