Sedation
Conditions
Brief summary
The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).
Interventions
DRUGChloral Hydrate
Oral chloral hydrate 50 mg/kg
DRUGDexmedetomidine
Intranasal dexmedetomidine 3 mcg/kg
OTHEROral placebo
Oral saline administered
OTHERIntranasal placebo
Intranasal saline administered
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
6 Months to 8 Years
Healthy volunteers
No
Inclusion criteria
* Patient scheduled for ABR exam with sedation to be administered according to protocol by nurse in keeping with standard practice at the TCH Audiology clinic.
Exclusion criteria
* Patients younger than 6 months or older than 8 years * Previously failed sedation * Weight greater than 25 kg * Weight less than 5 kg * BMI above 30 * Diagnosis of ADHD * Any patient deemed inappropriate for nurse administered sedation * Patients with any cardiac disease * Obstructive sleep apnea
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Complete Study | 60-180 minutes | Time from medication administration to study completion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oral Placebo and Intransal Dexmedetomidine | 44 |
| Oral Chloral Hydrate and Intranasal Placebo | 41 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 4 |
Baseline characteristics
| Characteristic | Oral Placebo and Intransal Dexmedetomidine | Oral Chloral Hydrate and Intranasal Placebo | Total |
|---|---|---|---|
| Age, Continuous | 23.33 months STANDARD_DEVIATION 12.63 | 25.55 months STANDARD_DEVIATION 11.21 | 24.40 months STANDARD_DEVIATION 11.95 |
| Region of Enrollment United States | 44 participants | 41 participants | 85 participants |
| Sex: Female, Male Female | 21 Participants | 14 Participants | 35 Participants |
| Sex: Female, Male Male | 23 Participants | 27 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 44 | 0 / 41 |
| serious Total, serious adverse events | 0 / 44 | 0 / 41 |
Outcome results
Primary
Time to Complete Study
Time from medication administration to study completion.
Time frame: 60-180 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Oral Placebo and Intransal Dexmedetomidine | Time to Complete Study | 85.5 Minutes |
| Oral Chloral Hydrate and Intranasal Placebo | Time to Complete Study | 110 Minutes |