Phase 3
N=400
Dexmedetomidine as a Rapid Bolus in Children for Emergence Agitation
Tonsillectomy
Bottom Line
View on ClinicalTrials.gov: NCT01528891 ↗Enrolled (actual)
400
Serious AEs
0.3%
Results posted
Nov 2015
Primary outcome: Primary: Heart Rate (HR) — 120; 121; 107; 121 bpm — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexmedetomidine (Drug); Placebo (Other)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Peter Davis
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heart Rate (HR) |
120; 121; 107; 121; 104; 120 | <0.01 sig |
| PRIMARY Systolic Blood Pressure (SBP) |
99; 99; 104; 100; 99; 99 | <0.01 sig |
| PRIMARY Diastolic Blood Pressure (DBP) |
47; 47; 52; 47; 48; 47 | <0.01 sig |
| SECONDARY Incidence of Emergence Agitation (EA) |
36; 66; 30; 61 | <0.0001 sig |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01528891). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.