clinical trial · NCT02037893
Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
Acute Otitis MediaAntipyrine and Benzocaine otic solutionAntipyrine Otic SolutionBenzocaine Otic SolutionPlacebo Otic solution
brief summary
The primary objective is to compare the effect of treatment with a combination of ear solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute otitis media.
started
Nov 1, 2013
primary completion
Sep 1, 2014
completion
Sep 1, 2014
last updated
Aug 7, 2024
detailed description
Reduction of pain symptoms will be measured by using the Face, Legs, Activity, Cry, Consolability Scale (FLACC) and the Faces pain Scale Revised (FPS-R).
official title
A Four-arm, Randomized, Double-blind, Active and Placebo Controlled Study to Determine the Safety and Efficacy of a Combination Antipyrine and Benzocaine Otic Solution Compared With Antipyrine Otic Solution Alone, Benzocaine Otic Solution Alone and to Placebo Otic Solution to Relieve Pain Symptoms in Children With Acute Otitis Media.
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol