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
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