Comparison Of Dexmedetomidine Versus Tramadol As An Adjuvant With Bupivacaine In Caudal Block For Intra-Operative Hemodynamic Stability And Post-Operative Pain In Children Undergoing Inguinal Hernia Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hemodynamic Stability
研究概览
简要总结
Among the postoperative adverse effects, pain has significant importance. Caudal block is a common technique for pediatric analgesia for infraumbilical surgeries. Because of the shortduration of analgesia with bupivacaine alone various additive have been used to prolong the action of bupivacaine. Tramadol has a centrally acting analgesic effect via opioid receptors.Adding Dexmedetomidine to bupivacaine has proven effectiveness for postoperative painrelief. But not much research has been conducted before regarding this comparison which can help us to find the more effective drug for induction of anesthesia.So we want to conduct this randomized trial. Sample size of 60 cases; 30 cases in each group will be included through Nonprobability convenience sampling and will be randomly divided in two groups. In group A,patients will be given 0.25% bupivacaine 1 mL/kg with dexmedetomidine0.5 μg/kg. In group B, patients will be given 0.25% bupivacaine 1 mL/kg with 1mg/kg of tramadol. Heart rate and mean arterial pressure will be assessed before induction of anesthesia, after 5, 10, 15 and 30 mins of induction and at the time of extubation. After surgery, total duration from surgery and first rescue analgesia will be noted. All the information will be recorded on proforma. Data will be entered & analyzed by using SPSS version 20. Both groups will be compared for mean heart rate, MAP and time to first rescue analgesia by using independent samples t-test. P-value ≤0.05 will be considered as significant. So this study will be done in a local setting to get local evidence and implement the use of more appropriate drug with less postop complications, especially in pediatric age group patients. This will help to improve our practice and local guidelines.
详细描述
After taking approval from hospital ethical committee, 60 children fulfilling the selection criteria will be included in the study from ward of Department of Pediatrics, DHQ Teaching Hospital, Sahiwal. An informed consent will be taken. Demographic information (name, age,gender, weight, ASA and duration of surgery) will be noted.Then children will be randomly divided in two groups by using lottery method for caudal block. In both groups children will be anesthetized generally using Propofol 2.5mg/kg bodyweight, Atracurium 0.5mg/kg body with dexmedetomidine 0.5μg/kg. In group B, patients will be given0.25% bupivacaine 1 mL/kg with 1mg/kg of tramadol. All anesthesia procedures will be done by researcher under supervision of senior consultant anesthesiologist having 4 years residency experience. Heart rate and mean arterial pressure will be assessed after 5,10,15 and 30 mins of induction and at the time of extubation.Neostigmine 0.05mg/kg plus Glycopyrolate 0.2mg/1mg of neostigmine will be used as reversal agents. After surgery, children will be shifted in post-surgical wards and will be followed-up there for 24 hours. Children will be assessed for postoperative pain score. If pain score will be greater than or equal to 5 on FLACC scale, then rescue analgesia will be given and total duration from surgery and first rescue analgesia will be noted (as per operational definition). All the information will be recorded on proforma attached.
definition). All the information will be recorded on proforma (attached). pressure will be assessed before induction of anesthesia, after 5, 10, 15 and 30 minutes weight and appropriate sized endotracheal tube (ETT) according to the age. In group A, patients will be given 0.25% bupivacaine 1 mL/kg
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 15 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children of age 5-15 years.
- •Either gender,
- •Elective inguinal hernia surgery.
- •Proposed duration of surgery <60 minutes.
排除标准
- •• Emergency surgery
- •Children with evidence of infection at back, allergy to trial drugs, bleeding/coagulation disorder (PT>15sec), history of developmental delay, sepsis, pre-existing neurological or spinal diseases (on medical record)
- •Expected duration of surgery >120 minutes
研究组 & 干预措施
Bupivacaine with Dexmetedomidine group
In group A, patients will be given 0.25% bupivacaine 1 mL/kg with dexmedetomidine 0.5μg/kg
干预措施: Bupivacaine with Dexmetedomidine (Drug)
Bupivacaine with Tramadol group
In group B, patients will be given 0.25% bupivacaine 1 mL/kg with 1 mg/kg of tramadol
干预措施: Bupivacaine with Tramadol (Drug)
结局指标
主要结局
Hemodynamic Stability
时间窗: Blood pressure will be assessed before induction of anesthesia, after 5, 10, 15 and 30 minutes of induction and at the time of extubation.
Blood pressure
Post Op Analgesia
时间窗: After 24hours, children will be assessed for postoperative pain score
post operative first rescue analgesia
次要结局
未报告次要终点
研究者
Hafiz Dr Naeem Abbas
Resident Anaesthetist
Sahiwal medical college sahiwal
