Trial Outcomes & Findings for The Use of Dexmedetomidine for EEG Sedation in Children With Behavioural Disorders (NCT NCT03799783)

NCT ID: NCT03799783

Last Updated: 2021-02-02

Results Overview

the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

10 minutes

Results posted on

2021-02-02

Participant Flow

Participant milestones

Participant milestones
Measure
Dexmedetomidine
2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete
Overall Study
STARTED
19
Overall Study
COMPLETED
19
Overall Study
NOT COMPLETED
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
Dexmedetomidine
n=19 Participants
2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete
Age, Continuous
7.3 years
STANDARD_DEVIATION 4 • n=19 Participants
Sex: Female, Male
Female
10 Participants
n=19 Participants
Sex: Female, Male
Male
9 Participants
n=19 Participants

PRIMARY outcome

Timeframe: 10 minutes

the PSSS is a validated scale for assessing the level of procedural sedation. It is a 6 items scale , from 0 to 5, where 5 is an alert patient and 0 is a deep sedation with abnormal vital signs. We evaluate patients 10 minutes after the infusion of dexmedetomidine.

Outcome measures

Outcome measures
Measure
Dexmedetomidine
n=19 Participants
2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete
Number of Patients That Reach a Score Equal or Lower Than 2 Ten Minutes After the Infusion of Dexmedetomidine (Assessed With the PSSS Pediatric Sedation State Scale)
13 Participants

SECONDARY outcome

Timeframe: during and immediately after DEX infusion, up to 150 minutes after DEX infusion (time to first awakening)

any adverse event potentially related with DEX-administration

Outcome measures

Outcome measures
Measure
Dexmedetomidine
n=19 Participants
2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete
Number of Patients With Adverse Events
10 Participants

Adverse Events

Dexmedetomidine

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Dexmedetomidine
n=19 participants at risk
2 mcg/Kg iv dexmedetomidine (this dose may be repeated up to 2 times) followed by 1-2 mcg/Kg/hour iv continuous infusion dexmedetomidine: To administrater dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete
Cardiac disorders
hypotension
31.6%
6/19 • Number of events 6 • 90 minutes
Other (not including serious) adverse events
Cardiac disorders
bradycardia
21.1%
4/19 • Number of events 4 • 90 minutes
Other (not including serious) adverse events

Additional Information

Angela Amigoni, MD

University Hospital Padova

Phone: 339 8333765

Results disclosure agreements

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