Overview

This trial is active, not recruiting.

Conditions laceration, anxiety
Treatments dexmedetomidine, midazolam
Phase phase 4
Sponsor University of Pittsburgh
Start date June 2014
End date April 2015
Trial size 40 participants
Trial identifier NCT02168439, PRO13120431, UL1TR000005

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Intranasal Dexmedetomidine 2 micrograms/kilogram once
dexmedetomidine Precedex
(Experimental)
Intranasal Midazolam 0.4 milligram/kilogram
midazolam Versed

Primary Outcomes

Measure
mYPAS score as completed by researchers to assess anxiety
time frame: Day 1

Secondary Outcomes

Measure
VAS for anxiety as completed by caregiver and observer
time frame: Day 1

Eligibility Criteria

Male or female participants from 1 year up to 5 years old.

Inclusion Criteria: - Presenting to Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center - Laceration <5 cm in total length - Require simple suture laceration repair Exclusion Criteria: - Allergies/intolerance/contraindication to the study drugs - Lacerations requiring complex (multilayer) repair or total laceration length>5cm

Additional Information

Official title Double Blinded Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department
Principal investigator Desiree Neville, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by University of Pittsburgh.