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Intranasal Fentanyl in Combination With Midazolam Versus Midazolam Alone for Pediatric Facial Laceration Repair

NCT04745260 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-02-09

No results posted yet for this study

Summary

The purpose of the study is to compare the effectiveness of a combination of intranasal fentanyl and intranasal midazolam to intranasal midazolam alone for analgesia and anxiolysis in patients presenting for facial laceration repair in the pediatric emergency department.

Conditions

Interventions

DRUG

Intranasal Fentanyl Spray and Intranasal Midazolam Spray

Intranasal Fentanyl 2mcg/kg and Intranasal Midazolam 0.2mg/kg

DRUG

Intranasal Midazolam Spray

Intranasal Midazolam 0.3mg/kg

Sponsors & Collaborators

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Brittany J DiFabio, MD · University of Texas at Austin

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
7 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-11-01
Completion
2021-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04745260 on ClinicalTrials.gov