Adjuncts to Caudal Block in Pediatrics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- Time of first request of analgesia
研究概览
简要总结
One of the most commonly used regional anesthetic techniques in pediatric surgeries is the caudal epidural block. Its main disadvantage remains the short duration of action. Hence, different additives have been used. Dexmedetomidine as an additive to the local anesthetic bupivacaine in caudal epidural analgesia prolongs the duration of postoperative analgesia so is dexamethasone. The investigators aimed to study the effect of combining both additives in the duration of analgesia, decreasing side effects and decreasing anesthetic doses
详细描述
Sixty three children scheduled for hypospadias randomized into 3 groups. Group I (n=21) (dexamethasone 0.1mg/kg+ 0.5ml/kg bupivacaine 0.25%), group II(n=21)( dexmedetomidine 0.01ug/kg+ 0.5ml/kg bupivacaine 0.25%)and groupIII(n=21)(dexamethasone0.1mg/kg+dexmedetomidine0.01ug/kg +0.5ml/kg bupivacaine 0.25%).intraoperative and postoperative hemodynamics were recorded. In PACU, MOPS scores and sedation scores were recorded at 30min,1,2,3,6and 12hrs. Also the time of first analgesic request was recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The Patients allocated to study groups using computer generated random list & group assignment was sealed in sequentially numbered opaque envelopes that opened after induction of anesthesia.
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •1 - ASA I-II 2- Males only 3- Children aged from 1-6 years 4- Children scheduled for hypospadias surgery
排除标准
- •Contraindication to caudal anesthesia.
- •cardiovascular diseases.
- •drug allergy.
- •Type I diabetes.
- •Clotting disorders.
- •Mentally retarded children or those whose families did not approve inclusion in the study
研究组 & 干预措施
Dexamethasone group
In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + (0.1 mg/kg dexamethazone) caudally.
干预措施: Dexamethasone (Drug)
Dexamethasone group
In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + (0.1 mg/kg dexamethazone) caudally.
干预措施: Bupivacaine (Drug)
Dexmedetomidine group
In this group the Patients received 0.5 ml/kg of bupivacaine 0.25% + dexmedetomidine(1 mu/kg) caudally.
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine group
In this group the Patients received 0.5 ml/kg of bupivacaine 0.25% + dexmedetomidine(1 mu/kg) caudally.
干预措施: Bupivacaine (Drug)
Combination group
In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + dexamethasone(0.1mg/kg) and dexmedetomidine (1 mu/kg) caudally.
干预措施: Dexamethasone (Drug)
Combination group
In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + dexamethasone(0.1mg/kg) and dexmedetomidine (1 mu/kg) caudally.
干预措施: Dexmedetomidine (Drug)
Combination group
In this group the patients received 0.5 ml/kg of bupivacaine 0.25% + dexamethasone(0.1mg/kg) and dexmedetomidine (1 mu/kg) caudally.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Time of first request of analgesia
时间窗: 12 hours
the time from caudal block to the first time to analgesic needs
pain scores
时间窗: 12 hours
the modified objective pain score
次要结局
- sedation score(12 hours)
- heart rates(beat/minute)(3 hours.)
- mean arterial pressure (mmhg)(3 hours)
研究者
Amany Hassan Saleh
principal investigator,MD of anesthesia and intensive care unit.
Cairo University