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

Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Laceration; Anxiety

Intervention: Dexmedetomidine (Drug); Midazolam (Drug)

Phase: Phase 4

Status: Enrolling by invitation

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
Desiree Neville, MD, Principal Investigator, Affiliation: Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center

Summary

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

Clinical Details

Official title: Double Blinded Randomized Controlled Trial of Intranasal Dexmedetomidine Versus Intranasal Midazolam as Anxiolysis Prior to Pediatric Laceration Repair in the Emergency Department

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: mYPAS score as completed by researchers to assess anxiety

Secondary outcome: VAS for anxiety as completed by caregiver and observer

Eligibility

Minimum age: 1 Year. Maximum age: 5 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Children's Hospital of Pittsburgh of UPMC, Pittsburgh, Pennsylvania 15224, United States
Additional Information

Starting date: June 2014
Last updated: June 17, 2014

Page last updated: August 23, 2015

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