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

Phase 4

Completed

• Conditions: Anxiety; Laceration
• Interventions: Drug: Dexmedetomidine; Drug: Midazolam

• Registration Number: NCT02168439
• Lead Sponsor: University of Pittsburgh

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-16
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-20
• Primary Completion: 2015-04
• Study Completion: 2016-06
• Results First Submitted: 2016-09-19
• Results First Submitted QC: 2017-01-20
• Results First Posted: 2017-03-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine	Dexmedetomidine	Intranasal Dexmedetomidine 2 micrograms/kilogram once
Midazolam	Midazolam	Intranasal Midazolam 0.4 milligram/kilogram

Primary Outcome Measures

Name	Time	Method
mYPAS Score as Completed by Researchers to Assess Anxiety	Day 1	Primary outcome was the mYPAS scores at the time of positioning for procedure.; mYPAS stands for modified Yale Preoperative anxiety scale. The scale is from minimum 23.3- maximum 100. Higher scores indicate higher anxiety. By prior characterization, scores less than or equal to 30 are classified as not anxious.

Secondary Outcome Measures

Name	Time	Method
VAS for Anxiety as Completed by Caregiver and Observer	Day 1	VAS, Visual Analog Scale for anxiety. Scale from 0-10 written on a 10 cm horizontal line with the extremes labeled as no anxiety to very anxious.; Vertical line is drawn on the scale at the level of anxiety. The distance was measured.; Higher numbers equal higher anxiety.
mYPAS Scores at Other Time Points	Day 1	mYPAS stands for modified Yale Preoperative anxiety scale. The scale is from minimum 23.3- maximum 100. Higher scores indicate higher anxiety. By prior characterization, scores less than or equal to 30 are classified as not anxious.

Trial Locations

Locations (1)

Children's Hospital of Pittsburgh of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States