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Study of FAECC Scale (Modified FLACC) to Evaluate Ear Pain in Children With Acute Otitis Media

NCT01588535 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2015-05-04

No results posted yet for this study

Summary

This study is to assess the reliability and validity of the FAECC scale to evaluate pain associated with acute otitis media in children aged 2 months to 5 years.

Conditions

Interventions

DRUG

benzocaine

benzocaine 10 mg/mL, five drops in affected ear canal each hour as needed

DRUG

placebo

placebo solution, five drops in affected ear canal each hour as needed

Sponsors & Collaborators

  • Arbor Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Laurence Downey, MD · Arbor Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
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 NCT01588535 on ClinicalTrials.gov