Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT02250820
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2014-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE)
Sponsor:
Children's Hospital Medical Center, Cincinnati
Organization:
Study Overview
Official Title:
A Qualitative Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will examine the quality of two sedation techniques (dexmedetomidine and pentobarbital) used for children aged 3 to 24 months who are undergoing a transthoracic echocardiography (TTE).
Detailed Description:
Currently there are two sedation methods used for children less than 24 months of age undergoing transthoracic echocardiography (TTE).
* One method provides sedation by mouth with the drug pentobarbital,
* The other provides sedation through the nose with the drug dexmedetomidine.
The choice of which method is used is based on evaluation of the patient's medical history and the preference of the anesthesiologist. To our knowledge, no study has compared these two sedation techniques for quality of care. The proposed study will help us determine which method yields the best quality and will allow us to improve the healthcare experience of our patients.
* One method provides sedation by mouth with the drug pentobarbital,
* The other provides sedation through the nose with the drug dexmedetomidine.
The choice of which method is used is based on evaluation of the patient's medical history and the preference of the anesthesiologist. To our knowledge, no study has compared these two sedation techniques for quality of care. The proposed study will help us determine which method yields the best quality and will allow us to improve the healthcare experience of our patients.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: