NCT01588535

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

Phase 2, Multicenter, Placebo-controlled, Double-masked, Randomized Study to Demonstrate Reliability and Validity of FAECC Scale (Modified FLACC) to Evaluate Relief of Pain in Subjects With Acute Otitis Media Aged >/=2 Months to <5 Years

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Arbor Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 2 Months – 4 Years
• Healthy volunteers: Not accepted

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.

Detailed description

to assess the reliability and validity of the FAECC pain scale tool in children aged 2 months to 5 years with acute otitis media given AR01 or placebo

Conditions

• Pain
• Otitis Media

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-05-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2012-05-01
• Last updated: 2015-05-04

Locations

15 sites across 1 country: United States