ED50 and ED95 of Intranasal Dexmedetomidine in Pediatric Patients Undergoing Transthoracic Echocardiography Study

Guangzhou Women and Children's Medical Center

Status and phase: Completed; Phase 4

Conditions: Patients for Transthoracic Echocardiography; Unknown Diagnosis

Treatments: Drug: intranasal dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT02780427

Wzhang03

Details and patient eligibility

About

The median effective dose (ED50) and ED95 of intranasal dexmedetomidine as a single bolus have not been described for sedation in children undergoing transthoracic echocardiography (TEE) study. This information is important to compare agents and to determine the most effective sedative dose. The investigators performed a two-stage study to determine the ED50 and the ED95 of intranasal dexmedetomidine to investigate age-related differences in participants undergoing transthoracic echocardiography study.

Full description

The investigators performed a two-stage study to determine the ED50 and the ED95 of intranasal dexmedetomidine in children undergoing transthoracic echocardiography study. In phase 1, 120 participants were randomized in a Dixon-Massey study to describe the minimum local sedative dose. In phase 2, a further 160 participants were randomly allocated to receive sedation with doses in the upper dose-response range to define the ED95

Enrollment: 320 patients

Sex: All

Ages: 1 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children, aged between one and 24 months. classified as (American Society of Anesthesiologists) ASA physical status I or II, undergoing TEE were enrolled in the study.

Exclusion criteria

• Known allergy or hypersensitive reaction to dexmedetomidine
• Organ dysfunction, and significant developmental delays or behavior problems
• Cardiac arrhythmia
• Known. acyanotic congenital heart disease or children after cardiac interventional procedures for follow-up examination.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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320 participants in 4 patient groups

1-6 months (Group 1)

Active Comparator group

Treatment:

Drug: intranasal dexmedetomidine

7-12 months (Group 2)

Active Comparator group

Treatment:

Drug: intranasal dexmedetomidine

13-18 months (Group 3)

Active Comparator group

Treatment:

Drug: intranasal dexmedetomidine

19-24 months (Group 4)

Active Comparator group

Treatment:

Drug: intranasal dexmedetomidine