A Prospective Randomized Trial of Sublingual Ketorolac Compared to Intranasal Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Bilateral Myringotomy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- duration of analgesia
研究概览
简要总结
The investigators aim to compare intranasal dexmedetomidine in a dose of 1ug.kg-1 with sublingual ketorolac in a dose of 1mg.kg-1 on postoperative behaviour in those children undergoing BMT during their PACU stay
详细描述
Data were analyzed through SPSS (Statistical Package for Social Sciences), Program version 22. Distribution of data was first tested by Shapiro test. Data were presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, an unpaired t-test was used to compare between mean values of both groups. For pain and sedation scores, Mann Whitney U test was used. Fisher's exact test was used for comparison of categorical data. The P value ≤ 0.05 was considered as the level of statistical significance.
A prior G power analysis was done. Using the results obtained from previous studies (14- 18) and assuming an alpha error of 0.05 and beta error 0f 0.2 (power of the study 80 %), a sample size of 60 patients per group was calculated. A drop out 10% of cases is expected, so; 33 cases per group will be required
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
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA physical status I- II.
排除标准
- •History of ketamine
- •History of NSAID
- •History of allergies
- •Any bleeding disorders
- •History of GIT bleeding
- •Those who will undergo other procedures in addition to bilateral myringotomy
研究组 & 干预措施
intranasal dexmedetomidine
this group is planned for intranasal dexmedetomidine
干预措施: intranasal dexmedetomidine (Drug)
sublingual ketorolac
this group is planned for sublingual ketorolac
干预措施: sublingual ketorolac (Drug)
结局指标
主要结局
duration of analgesia
时间窗: time from administering the study solution till the time for the first rescue analgesic] during first 24 hours
The duration of analgesia,define as the time to the first demand for rescue analgesic
次要结局
- Nausea and vomiting(For 24 hours after surgery)
- Heart rate(for 2 hours after the start of surgery)
- Number of patients received rescue analgesics(For 24 hours after surgery)
- Degree of sedation(For 24 hours after surgery)
- Postoperative pain score(For 24 hours after surgery)
- systolic blood pressure(for 2 hours after the start of surgery)