Comparative study to evaluate efficacy and safety of dexmeditomidine and clonidine as adjuvant with bupivacaine for caudal block in pediatric patients posted for infra umbilical surgeries.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare caudal epidural bupivacaine with clonidine & bupivacaine with dexmedetomidine regarding the duration of analgesia in pediatric patients posted for infraumbilical surgeries under general anesthesia
研究概览
简要总结
Caudal analgesia isan accepted and popular method of providing intra- and post-operative analgesiafor infra abdominal surgeries in children. Bupivacaine is the most commonlyused local anaesthetic for this purpose. The limitation of bupivacaine is theshort duration of action, about four to six hours, when administered as a‘single shot technique’. Several adjuncts such as opioids, ketamine, midazolam,clonidine and neostigmine have been used with bupivacaine to prolong its action(de Beer and Thomas, 2003), and thus extend the duration of post-operativeanalgesia provided by the ‘single shot’ caudal technique. Clonidine, an alpha 2agonist has extensively been used in neuraxial blocks(S et al., 1994) and peripheral nerve blocks to prolong theaction of bupivacaine. Dexmedetomidine is a useful non-opioid drug used to manage pain and sedation.
PRIMARYOBJECTIVES:
Tocompare caudal epidural bupivacaine with clonidine and bupivacaine withdexmedetomidine regarding the duration of analgesia in pediatric pts. postedfor infraumbilical surgeries under GA.
SECONDARYOBJECTIVES:
Toassess the synergistic effect and safety of adding dexmedetomidine tobupivacaine compared with clonidine to bupivacaine in caudal block ininfraumbilical surgeries.
Tocompare the haemodynamic changes during intraoperative and postoperativeperiod.
Tocompare the quality and duration of postoperative analgesia.
Tocompare the total amount of rescue analgesics used during the 12 hour postoperative period.
Tostudy the side effects and complications during the post operative period.
METHODOLOGY: Patients for the study will be conducted on 50 patients fulfilling the inclusion criteria. Patients will be randomly allocated into 2 study groups who will be administered with the following combination of drugs.
Group B will receive bupivacaine.25%(1ml/kg) andGroup C will receive bupivacaine .25%(1ml/k) with clonidine 1 µ/kg in normalsaline 1 ml**.**
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 2.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •Pediatric patients from 2 yrs to 6 years.
- •ASA grade I-II
- •Pediatric patients undergoing infraumbilical surgeries like hernia repair, circumcisions, orchidopexy, etc.
排除标准
- •1.Children less than 2 yrs or more than 6 yrs.
- •2.ASA grade III –IV.
- •3.Known allergy to any of the study drugs.
- •4.Pre-operative hepatic or renal dysfunction.
- •5.Serious cardiac or respiratory disease.
- •6.History of developmental delay or mental retardation.
- •7.Known or suspected coagulopathy.
- •8.Signs of infection at the site of the proposed caudal block.
结局指标
主要结局
To compare caudal epidural bupivacaine with clonidine & bupivacaine with dexmedetomidine regarding the duration of analgesia in pediatric patients posted for infraumbilical surgeries under general anesthesia
时间窗: 12 hours
次要结局
- To assess the synergistic effect & safety of adding dexmedetomidine to bupivacaine compared with clonidine to bupivacaine in caudal block in infraumbilical surgeries.(To compare the haemodynamic changes during intraoperative and postoperative period.)