The Effects of Gastro-esophageal Acid Suppression on Post-tonsillectomy Pain
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- The Primary Outcome is the Number of Days to Become Free of Narcotic Pain Medication.
研究概览
简要总结
This study was designed to determine whether post-operative pain following a tonsillectomy can be reduced by adding an antacid-like medication to the medications taken after surgery. It is hypothesized that even a small amount of stomach acid backing up and entering the mouth can increase post-tonsillectomy pain. Therefore, the use of an antacid-like medication should help to decrease pain and reduce the amount of narcotic medication required for pain control.
详细描述
This study has been limited to children and adolescents ages 5-18 who are undergoing tonsillectomy for an indication of obstructive sleep disturbance (snoring, choking/gasping or pauses in breathing during sleep.)
Study participants will be randomized to two groups: study medication (Lansoprazole) or an inactive substance(placebo).
Participants will be asked to do all of the following:
- Take the study medication twice a day for 14 days.
- Keep a log book which will include:
- Record the medications and amount of each medication taken each day for 14 days. This includes pain medication and the study drug.
- Record your child's activity level daily for 14 days.
- Collect your child's urine one time daily and test it using special medicated strips to monitor their daily liquid intake for 14 days.
- Meet with a Research Assistant or Study Physician 14-21 days after the study to collect the log book and perform a post-operative examination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All healthy children ages 5-18 years scheduled for tonsillectomy and /or adenotonsillectomy for sleep disturbance secondary to airway obstruction at Children's Hospital Boston
排除标准
- •Patients on any medications other than the study drug (Lansoprazole or placebo), Amoxicillin®, and acetaminophen with or without codeine
- •An underlying medical condition which would necessitate an alteration in the anesthetic regimen
- •Patients allergic to any of the medications in the protocol
- •History of chronic tonsillitis
- •History of chronic pain conditions
- •History of active gastro-esophageal reflux disease
- •Surgery in addition to tonsillectomy/adenotonsillectomy (except for myringotomy)
- •Cognitive/developmental disorders
- •Inability to use a self-report pain scale
研究组 & 干预措施
1
Post-operative administration of Lansoprazole
干预措施: Lansoprazole (Drug)
2
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The Primary Outcome is the Number of Days to Become Free of Narcotic Pain Medication.
时间窗: 2 weeks
次要结局
- The Secondary Outcomes Are the Number of Days to be Free of Pain, the Number of Days to Return to Normal Activity Levels and the Number of Days to Return to Normal Fluid Intake.(2 weeks)
研究者
Manali Amin
Instructor
Boston Children's Hospital