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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02168439
• Other study ID #: PRO13120431
• Secondary ID: UL1TR000005
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 16, 2014
• Last updated: January 13, 2016
• Start date: June 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anxiety
• Laceration
• Lacerations

Intervention

Drug:
• Dexmedetomidine

• Midazolam

Locations

Country	Name	City	State
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedure completion	note of whether the procedure was able to be completed	Day 1	No
Other	Need for procedural sedation	Whether the patient required procedural sedation for completion of the procedure	Day 1	No
Other	Anxiolysis satisfaction	Likert scale parent, child life and proceduralist survey	Day 1	No
Primary	mYPAS score as completed by researchers to assess anxiety		Day 1	No
Secondary	VAS for anxiety as completed by caregiver and observer		Day 1	No