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

NCT ID: NCT02168439

Last Updated: 2024-11-14

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Laceration Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dexmedetomidine

Intranasal Dexmedetomidine 2 micrograms/kilogram once

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Midazolam

Intranasal Midazolam 0.4 milligram/kilogram

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

Interventions

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Dexmedetomidine

Intervention Type DRUG

Midazolam

Intervention Type DRUG

Other Intervention Names

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Precedex Versed

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh Clinical and Translational Science Institute (CTSI)

UNKNOWN

Sponsor Role collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Desiree Neville, MD

M.D., Pediatric Emergency Medicine Fellow Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Desiree Neville, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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UL1TR000005

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO13120431

Identifier Type: -

Identifier Source: org_study_id

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