A Randomized Control Trial of Post-operative Course of Oral Dexamethasone and Effect on Opioid Usage in Pediatric Tonsillectomies in a Tertiary Care Center
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Opioid Use (Number of Doses)
研究概览
简要总结
The purpose of this study is to determine if a post-operative course of oral dexamethasone affects opioid usage in pediatric patients undergoing tonsillectomy.
Patients who are scheduled to undergo tonsillectomy or adenotonsillectomy are randomized to receive either 1) a post-operative steroid course of oral dexamethasone in addition opioids, acetaminophen,NSAIDs or 2) opioids/acetaminophen/NSAIDS alone. All drugs are prescribed per approved FDA labeling. Children between the ages of 4-17 will be considered for enrollment.
Participants (or with the aid of parents/legal guardian for subjects unable to complete on their own) will complete a diary twice a day to record pain medication administration and visual pain scale. Remaining steroid and opioid medication will be measured at the routine post-operative appointment that occurs 4 - 6 weeks following surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 4-17 years at time of surgery
- •Scheduled for tonsillectomy or adenotonsillectomy surgery
排除标准
- •Prior history of intracapsular tonsillectomy
- •Previous diagnoses of Down Syndrome or developmental delay
- •Presence of gastrostomy (g) tube
- •A contraindication to steroids or steroid usage within 30 days prior to surgery including diabetes, allergy to steroid, already on chronic steroid, immune deficiency
- •Active infection or concurrent operative procedures at the time of surgery
- •Unable to read or speak English
- •Pregnant or breastfeeding females
研究组 & 干预措施
Dexamethasone plus analgesics
oral dexamethasone of 0.5mg/kg/day (max of 8mg/day), administered on post-operative days 1,3,5,7 in addition to standardized course of analgesics (opioids/acetaminophen/NSAIDs).
干预措施: Dexamethasone (Drug)
Dexamethasone plus analgesics
oral dexamethasone of 0.5mg/kg/day (max of 8mg/day), administered on post-operative days 1,3,5,7 in addition to standardized course of analgesics (opioids/acetaminophen/NSAIDs).
干预措施: Analgesics (Drug)
analgesics alone
standardized course of analgesics (opioids/acetaminophen/NSAIDs)
干预措施: Analgesics (Drug)
结局指标
主要结局
Opioid Use (Number of Doses)
时间窗: 4 weeks post-op
Measured by medication log and units remaining.
Average Pain Score
时间窗: 14 days post-op
Measured by a visual analog scale, where 0 is no pain and 10 is worst possible pain.
次要结局
- Number of Participants With Post-operative Complications(30 days post-op)