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

University of Pittsburgh

Status and phase: Completed; Phase 4

Conditions: Laceration; Anxiety

Treatments: Drug: Dexmedetomidine; Drug: Midazolam

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02168439

PRO13120431

UL1TR000005 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

Dexmedetomidine

Experimental group

Description:

Intranasal Dexmedetomidine 2 micrograms/kilogram once

Treatment:

Drug: Dexmedetomidine

Midazolam

Experimental group

Description:

Intranasal Midazolam 0.4 milligram/kilogram

Treatment:

Drug: Midazolam