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

NCT02168439 | Completed Phase 4 Results DMC

• 2 other identifiers: PRO13120431UL1TR000005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Laceration; Anxiety

Keywords

Dexmedetomidine; Midazolam

Outcome Measures

Primary Outcomes (1)

• mYPAS Score as Completed by Researchers to Assess Anxiety

  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.

  Day 1

Secondary Outcomes (2)

• mYPAS Scores at Other Time Points

  Day 1

• VAS for Anxiety as Completed by Caregiver and Observer

  Day 1

Other Outcomes (3)

• Procedure Completion

  Day 1

• Need for Procedural Sedation

  Day 1

• Anxiolysis Satisfaction

  Day 1

Study Arms (2)

Dexmedetomidine

EXPERIMENTAL

Intranasal Dexmedetomidine 2 micrograms/kilogram once

Drug: Dexmedetomidine

Midazolam

EXPERIMENTAL

Intranasal Midazolam 0.4 milligram/kilogram

Drug: Midazolam

Interventions

Dexmedetomidine DRUG

Also known as: Precedex

Dexmedetomidine

Midazolam DRUG

Also known as: Versed

Midazolam

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Presenting to Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center
• Laceration \<5 cm in total length
• Require simple suture laceration repair

You may not qualify if:

• Allergies/intolerance/contraindication to the study drugs
• Lacerations requiring complex (multilayer) repair or total laceration length\>5cm

Sponsors & Collaborators

• University of Pittsburgh: lead
• University of Pittsburgh Clinical and Translational Science Institute (CTSI): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

MeSH Terms

Conditions

Lacerations; Anxiety Disorders

Interventions

Dexmedetomidine; Midazolam

Condition Hierarchy (Ancestors)

Wounds and Injuries; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

2 patients not included in the midazolam group: one for equipment malfunction leading to no data collected and the second due to weight error resulting in the patient receiving over twice the dose. Both recognized around the time of enrollment.

Results Point of Contact

• Title: Desiree Neville
• Organization: Children's Hospital of Pittsburgh of UPMC

desiree.neville@chp.edu

4126927692

Study Officials

• Desiree Neville, MD

  Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Pediatric Emergency Medicine Fellow Physician

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: June 20, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2016
• Last Updated: November 14, 2024
• Results First Posted: March 10, 2017

Record last verified: 2024-11

Locations

US (1)