Comparative Evaluation of Dexamethasone and Dexmedetomidine as Adjuvants for Bupivacaine in Ultrasound Guided Infraorbital Nerve Block in Infants for Cleft Lip Repair
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Postoperative FLACC scale
研究概览
简要总结
To assess the efficacy of dexamethasone versus dexmedetomidine as adjuncts to bupivacaine for infra-orbital nerve block in infants undergoing cleft lip surgery.
详细描述
Regarding patient registry; A prior G power analysis was done. Using the results obtained from previous studies and assuming an alpha error of 0.05 and beta error 0f 0.2 (power of the study 80 %), a sample size of 20 patients per group was calculated. A drop out 10% of cases is expected, so; 22 cases per group will be required.
Statistical analysis
Data will be analyzed through SPSS (Statistical Package for Social Sciences). Program version 22. Distribution of data will be first tested by Shapiro test. Data will be presented as mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, unpaired t test will be used to compare between mean values of both groups. For pain and sedation scores, Mann Whitney U test will be used. Fisher's exact test will be used for comparison of categorical data. The P value ≤ 0.05 will be considered as the level of statistical significance.
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, Care Provider)
入排标准
- 年龄范围
- 1 Month 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American society of anesthesiologist (ASA) physical status I or II
排除标准
- •known allergy to any of drugs used
- •coagulopathy
- •any wound or infection related to puncture site
- •major illness
- •failure to gain consent of parents.
研究组 & 干预措施
Dexmedetomidine group
Dexmedetomidine in conjunction with bupivacaine for infra-orbital nerve block
干预措施: Dexmedetomidine group (Drug)
Dexamethasone group
Dexamethasone in conjunction with bupivacaine f
干预措施: Dexamethasone group (Drug)
结局指标
主要结局
Postoperative FLACC scale
时间窗: for 24 hours after surgery
FLACC scale: 0 : relaxed/ comfortable, 1-3 : mild discomfort, 4-6 : moderate discomfort, 7- 10: sever discomfort/ Pain / both,
Postoperative sedation score
时间窗: for 4 hours after surgery
The degree of sedation will be assessed by using a three point sedation scale based on eye opening: - Alert with spontaneous eye opening 0, - Drowsy with eyes only opening in response to speech 1, - Sedated with eyes opening in response to physical stimulation 2,
次要结局
- Heart rate(For 4 hours after induction)
- Postoperative nausea(for 24 hours after surgery)
- Systolic blood pressure(For 4 hours after induction)
- Haematoma formation after surgery(for 24 hours after surgery)
- Postoperative vomiting(for 24 hours after surgery)