Study of Caudal Ropivacaine With or Without Dexmedetomidine for Postoperative Analgesia in Pediatric Infra-umbilical Surgery: A Double-blinded Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Duration of analgesia:
研究概览
简要总结
The goal of this clinical trial is to evaluate the postoperative analgesic effects of caudal Ropivacaine with or without Dexmedetomidine in pediatric infraumbilical surgery. The main question[s] it aims to answer are:
• if Caudal Dexmedetomidine with Ropivacaine would prolong the duration of analgesia in children undergoing infraumbilical surgery.
Participants will receive ropivacaine with dexmedetomidine in infraumbilical surgery.
If there is a comparison group: Investigators will compare this with ropivacaine with a placebo to see if the duration of analgesia differs.
详细描述
Children have significant pain following surgery. It has been under-managed most of the time. Poorly controlled post-operative pain increases the morbidity. It leads to post-operative agitation, urinary retention, nausea and vomiting, hypoxia, pulmonary edema, cardiovascular and temperature instability. So, postoperative pain management is an essential and important component of pediatric postoperative care. Adequate pain control after surgery permits early mobilization, reduces postoperative complication, prevents development of fear and anxiety and allows early hospital discharge.
Caudal block is one of the modality of multimodal analgesia. It is a well-established, effective and relatively safe technique used for intra and post-operative analgesia in children undergoing abdominal and lower limb surgery. It provides excellent analgesia, reduces intra-operative anesthetics drug requirements, ensures pain free recovery from anesthesia, decreases stress response and avoids deleterious adverse effects of narcotic drugs.
However, the main disadvantage of caudal block is being its short duration of action with sole local anesthetics. Even long-acting local anesthetic drugs such as bupivacaine provides only 4-8 hours of analgesia. The insertion of catheter in caudal space to administer repeated doses or continuous infusions of local anesthetic drug is not popular because of concerns of infection. So, various adjuvants like Fentanyl, Morphine, Ketamine, clonidine, Dexmeditomidine etc. have been used to prolong the duration of analgesia.
Morphine and Fentanyl are opioids that have been used traditionally in combination with a local anesthetic to achieve prolonged anesthetic effect. The addition of opioid does provide better analgesia but there is a possibility of an increased incidence of pruritus, urinary retention, nausea, vomiting and respiratory depression. Similarly, Ketamine and Clonidine are the widely preferred adjuvant to caudal block but have their own number of unpleasant adverse effects8.
Hence, there is still ongoing investigations to find for an adjuvant that can safely prolong caudal analgesia. Recently, Dexmedetomidine has been used for this purpose. Various studies have described the use of Dexmedetomidine with local anesthetic drugs in caudal block for the management of postoperative pain in children. Saadawy et al. found that 1μg/kg caudal dexmedetomidine with bupivacaine was associated with an extended duration of postoperative analgesia while in other studies 2μg/kg Dexmedetomidine was used with caudal Bupivacaine or Ropivacaine for providing postoperative analgesia in children undergoing lower abdominal and perineal surgeries.
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)
盲法说明
Children were randomly assigned to two groups having 31 children in each, by using a computer-generated table of random numbers which was enclosed in a sealed envelope and was opened by an anesthesiologist who were not involved in the study.
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
- •Children of either sex aged 2-7 years
- •ASA (American Society of Anesthesiologist) physical status I or II
- •Patients undergoing elective infraumbilical surgeries
排除标准
- •History of neuromuscular or psychiatric disease
- •Coagulation disorders
- •Skin lesion at the site of injection
- •Spine deformity
- •History of developmental delay
- •Allergy to study drugs
研究组 & 干预措施
Ropivacaine with dexmedetomidine
干预措施: ropivacaine with dexmedetomidine (Drug)
Ropivacaine with Normal Saline
干预措施: Ropivacaine with placebo (Drug)
结局指标
主要结局
Duration of analgesia:
时间窗: upto first 24 hour after intervention
The primary outcome will be the duration of analgesia defined as the time period between administration of study drugs to first need of rescue analgesia when until the time of rFLACC score (revised Face, Legs, Activity, Cry, and Consolability) reached ≥4.
Total analgesics consumption in first 24 hours postoperative period
时间窗: first 24 hours after intervention
If r-FLACC pain score ≥4 at any time, an injection Paracetamol 15mg/kg will be given. If the r-FLACC pain score still ≥4 after 30 minutes of injection Paracetamol, then the child will treated with an injection Pethidine 0.5mg/kg. After that, an injection Paracetamol at 15mg/kg will be given 6 hourly. Total analgesic consumption in the first 24 hours will be calculated by adding the total analgesic consumed in 24 hours after the intervention.
Post-operative pain Assessment (rFLACC score) rFLACC score (revised Face, Legs, Activity, Cry, and Consolability)
时间窗: first 24 hour after intervention
Each of the five categories F (face), L (legs), A (Activity), C (Cry), C (Consolability) will be scored from 0 to 2 which results total score in between zero and ten.
次要结局
- Side effects of study drugs(monitored for 24 hours and treated accordingly)
研究者
Kaushal Tamang
Principal Investigator
National Academy of Medical Sciences, Nepal
