NCT02250820

A Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography (TTE)

A Qualitative Comparison of Two Sedation Techniques in Children Undergoing Transthoracic Echocardiography

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 3 Months – 24 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Disease

Interventions

Type	Name	Description
DRUG	Dexmedetomidine	Nasal administration
DRUG	Pentobarbital	Oral administration
OTHER	Oral Placebo	Oral placebo will be cherry syrup
OTHER	Nasal Placebo	Nasal placebo will be nasally atomized saline

Timeline

• Start date: 2014-11-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2014-09-26
• Last updated: 2020-01-21

Locations

1 site across 1 country: United States