Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation

Peter Davis

Status and phase: Completed; Phase 3

Conditions: Tonsillectomy

Treatments: Other: Placebo; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01528891

PRO11070498

Details and patient eligibility

About

To Determine The Efficacy of a Rapid Bolus Injection of Dexmedetomidine on the Incidence of Emergence Agitation in Anesthetized Children and the Cardiovascular Profile of a Rapid Bolus Injection of Dexmedetomidine.

Enrollment: 418 patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children undergoing tonsillectomy with and without adenoidectomy and myringotomy and tube insertion
• ASA 1,2,3
• females who have started menses but have a negative urine pregnancy test

Exclusion criteria

• patients with known dysrhythmias,
• not recovering in the ICU
• developmental delay,
• autism communication disorder
• bleeding disorder
• PI discretion

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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418 participants in 2 patient groups, including a placebo group

Dexmedetomidine

Active Comparator group

Description:

Dexmedetomidine

Treatment:

Drug: Dexmedetomidine

placebo

Placebo Comparator group

Description:

Normal saline

Treatment:

Other: Placebo