Effect of Steroids on Post-tonsillectomy Morbidities
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Occurence of Post-operative Nausea
研究概览
简要总结
This study aims to evaluate the effect of postoperative systemic rapid onset and short acting dexamethasone followed by a tapering dose of oral prednisolone on post-tonsillectomy morbidities. Half of the patients who comply with the inclusion criteria were selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo.
详细描述
The effect of preoperative systemic steroids on post-tonsillectomy morbidities such as pain, nausea, vomiting and delayed feeding was proven. However, this study aims to evaluate the effect of postoperative systemic rapid onset and short acting dexamethasone followed by a tapering dose of oral prednisolone on the aforementioned morbidities and on decreasing the duration and costs of hospital stays. patients who were in the waiting list for tonsillectomy procedure were screened for medical history and those who comply with the inclusion criteria were randomly assigned into two equal groups of 50 patients each. One group was selected to receive a single postoperative dose of intravenous dexamethasone followed by oral steroids; the second group received placebo. Questionnaires investigating postoperative pain, nausea, vomiting, and oral intake were answered by patients, parents or guardians where applicable.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients in the waiting list for tonsillectomy under general anesthesia who accepted to participate in the study.
排除标准
- •Patients who are allergic to steroids or those who have medical conditions which contraindicate the use of steroid i.e diabetes mellitus, gastritis, or hypertension and those who were on exogenous steroid supplements.
研究组 & 干预措施
IV dexamethasone and oral Prednisolone
Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
干预措施: IV dexamethasone (Drug)
IV dexamethasone and oral Prednisolone
Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
干预措施: Oral prednisolone (Drug)
IV dexamethasone and oral Prednisolone
Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
干预措施: Paracetamol (Drug)
Placebo
Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
干预措施: Paracetamol (Drug)
Placebo
Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).
干预措施: IV saline (Drug)
结局指标
主要结局
Occurence of Post-operative Nausea
时间窗: 7 days
Postoperative nausea occurence (yes, no)
Maximum Severity of Post-operative Pain
时间窗: The severest pain grade felt within a week
5 grades (pain free, low disability and low intensity, low disability and high intensity, high disability and moderate intensity, high disability and severly limiting)
Duration of Post-operative Pain
时间窗: number of days at which pain was experienced within the the 1st sevn days post -surgery
4 selections (1 day, 2 days, 3 days, if more specify)
Onset of Post-operative Nausea
时间窗: onset of 1st ocurence of nausea attack within the 1st week post-surgery
Postoperative nausea onset (no nausea, immediate, 1st day, 2nd day, 3rd day, 4th day, 5th day, 6th day, 7th day)
Duration of Post-operative Nausea
时间窗: 7 days
Postoperative nausea duration (no nausea,1 day, 2 days, 3 days, 4 days, if more specify)
Occurence of Postoperative Vomiting
时间窗: 7 days
Postoperative vomiting occurrence (yes, no)
Total Number of Post-operative Vomiting Episodes
时间窗: total number of post-operative vomiting episodes which were experienced within the 1st week post-surgery
Postoperative vomiting number of attacks (no vomiting,1, 2, 3, if more specify)
次要结局
- Onset of 1st Post-operative Oral Intake(Onset of 1st post-operative oral intake recorded within the 1st 3days post-surgery)
- Average Amount of Meal Per Day(3 days)
- Average Frequency of Meals Per Day(average number of meals consumed per day for the 1st three days post-surgery)
研究者
Dr Faris Bahammam
Dr
King Fahd General Hospital