Conditions: Acute Otitis Media
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 112
Healthy volunteers: no

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.

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).

Arms:
arm 1: antipyrine 54 mg and benzocaine 14 mg. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping arm 2: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping arm 3: benzocaine 14 mg and glycerine dehydrated to 1.0 ml. Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping arm 4: Placebo otic solution will be glycerin that is dehydrated . Apply drops along the wall of the ear canal until filled and repeating every 3 hours for 24 hours unless the subject is sleeping

Interventions: intervention 1: Antipyrine and Benzocaine otic solution intervention 2: Antipyrine Otic Solution intervention 3: Benzocaine Otic Solution intervention 4: Placebo Otic solution
Intervention descriptions: intervention 1: antipyrine 54 mg and benzocaine 14 mg intervention 2: Antipyrine 54 mg and glycerine dehydrated to 1.0 mL intervention 3: benzocaine 14 mg and glycerine dehydrated to 1.0 mL intervention 4: Placebo otic solution will be glycerin that is dehydrated

Protocol document: