Phase 4 N=40 Randomized Quadruple-blind Supportive Care

Intranasal Dexmedetomidine vs Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair

Laceration · Anxiety

Bottom Line

View on ClinicalTrials.gov: NCT02168439 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2017

Primary outcome: Primary: mYPAS Score as Completed by Researchers to Assess Anxiety — 23.3; 36.3 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Dexmedetomidine (Drug); Midazolam (Drug)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: University of Pittsburgh
Primary completion: Apr 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY mYPAS Score as Completed by Researchers to Assess Anxiety	23.3; 36.3	—
SECONDARY mYPAS Scores at Other Time Points	48.8; 47.1; 42.5; 47.1; 23.3; 35.4	—
SECONDARY VAS for Anxiety as Completed by Caregiver and Observer	3.8; 3.5; 1.7; 1.6; .7; 1.2	—

Summary

The objective of this research study is to show superiority of intranasal dexmedetomidine to intranasal midazolam as anxiolysis prior to pediatric laceration repairs.

Eligibility Criteria

Inclusion Criteria

Presenting to Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
Laceration 5cm

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02168439). 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.