Trial Outcomes & Findings for A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams (NCT NCT01255904)

Results Overview

Time from medication administration to study completion.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

90 participants

Primary outcome timeframe

60-180 minutes

Results posted on

2016-05-16

Participant milestones
Measure	Oral Placebo and Intransal Dexmedetomidine Oral placebo followed by Intranasal dexmedetomidine 3 mcg/kg (max dose 100 mcg).	Oral Chloral Hydrate and Intranasal Placebo 50 mg/kg oral chloral hydrate followed by intranasal placebo.
Overall Study STARTED	45	45
Overall Study COMPLETED	44	41
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal
Measure	Oral Placebo and Intransal Dexmedetomidine Oral placebo followed by Intranasal dexmedetomidine 3 mcg/kg (max dose 100 mcg).	Oral Chloral Hydrate and Intranasal Placebo 50 mg/kg oral chloral hydrate followed by intranasal placebo.
Overall Study Physician Decision	1	4

A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams

Baseline characteristics by cohort
Measure	Oral Placebo and Intransal Dexmedetomidine n=44 Participants	Oral Chloral Hydrate and Intranasal Placebo n=41 Participants	Total n=85 Participants Total of all reporting groups
Age, Continuous	23.33 months STANDARD_DEVIATION 12.63 • n=5 Participants	25.55 months STANDARD_DEVIATION 11.21 • n=7 Participants	24.40 months STANDARD_DEVIATION 11.95 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	14 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	27 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants	41 participants n=7 Participants	85 participants n=5 Participants

Timeframe: 60-180 minutes

Time from medication administration to study completion.

Outcome measures
Measure	Oral Placebo and Intransal Dexmedetomidine n=44 Participants	Oral Chloral Hydrate and Intranasal Placebo n=41 Participants
Time to Complete Study	85.5 Minutes Interval 80.0 to 110.0	110 Minutes Interval 85.0 to 119.0

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Oral Placebo and Intransal Dexmedetomidine n=44 participants at risk	Oral Chloral Hydrate and Intranasal Placebo n=41 participants at risk
Respiratory, thoracic and mediastinal disorders mild hypoxia < 94% and > 90%	2.3% 1/44 • Number of events 1	0.00% 0/41
Respiratory, thoracic and mediastinal disorders partial airway obstruction	2.3% 1/44 • Number of events 1	0.00% 0/41

Baylor College of Medicine

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