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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 9
- 主要终点
- Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical Diagnosis of Acute Otitis Media
- •Moderate to severe pain
- •Normally active and in good health as determined by the PI
- •Parent or legal guardian consent
- •Caregiver available to complete diaries during study
排除标准
- •History of or current Perforated tympanic membrane
- •Tympanostomy tubes
- •Acute or chronic otitis externa
- •seborrheic dermatitis
- •Received any otic topical or systemic antibiotic within 14 days of enrollment
- •Receiving medication on a chronic basis for pain
- •Known hypersensitivity to investigational product.
- •clinical significant mental illness as determined by the PI
- •Exposed to another investigational agent within 30 days before study entry. Any condition the PI believed will interfere with the ability to comply with all study procedures
- •History of glucose 6-phosphate dehydrogenase deficiency
- •History or currently anemic
- •Congenital methemoglobinemia
- •Recent history of acute gastroenteritis within 14 days of enrollment
研究组 & 干预措施
Antipyrine and Benzocaine Otic solution
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
干预措施: Antipyrine and Benzocaine otic solution (Drug)
Antipyrine and Benzocaine Otic solution
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
干预措施: Placebo Otic solution (Drug)
Antipyrine Otic Solution
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
干预措施: Antipyrine Otic Solution (Drug)
Antipyrine Otic Solution
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
干预措施: Placebo Otic solution (Drug)
Benzocaine Otic Solution
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
干预措施: Benzocaine Otic Solution (Drug)
Benzocaine Otic Solution
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
干预措施: Placebo Otic solution (Drug)
Placebo
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
干预措施: Placebo Otic solution (Drug)
结局指标
主要结局
Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)
时间窗: Baseline and 1 hour after a single dose
The FLACC was completed by the caregiver to assess pain intensity for subjects aged 2 months to less than 5 years. The FLACC consists of five domains that are rated as 0, 1, or 2 (total scores range from 0 to 10). A lower score indicates lower level of pain. The FPS-R was completed by the subject aged 5 to 12 years. For this assessment, the subject selected the pain intensity by using faces that show increasing discomfort. Total scores range from 0 to 10. A lower score indicates lower level of pain.
次要结局
- Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R)15 Min Post First Dose(Change from Baseline to 15 min post first dose)
- Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 30 Min Post First Dose(Change from Baseline to 30 min post first dose)
- Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 3 Hour Post First Dose(Change from Baseline to 3 hour post first dose)
- Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 6 Hours Post First Dose(Change from Baseline to 6 hour post first dose)
- Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 12 Hours Post First Dose(Change from Baseline to 12 hour post first dose)
- Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 24 Hours Post First Dose(Change from Baseline to 24 hour post first dose)
- Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 36 Hours Post First Dose(Change from Baseline to 36 hour post first dose)
- Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 48 Hours Post First Dose(Change from Baseline to 48 hour post first dose)
- Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 60 Hours Post First Dose(Change from Baseline to 60 hour post first dose)
- Face, Legs, Activity, Cry, Consolability Scale (FLACC) or Faces Pain Scale Revised (FPS-R) 72 Hours Post First Dose(Change from Baseline to 72 hour post first dose)