A Comparative Study Between Dexamethasone and Ketamine as Adjuvants to Bupivacaine for Incisional Infiltration in Pediatric Abdominal Operations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The Face, Leg, Activity, Cry and Consolability scale (FLACC) pain scale
研究概览
简要总结
The aim of this study is to compare the effects of both ketamine and dexamethasone on the duration and magnitude of analgesia when combined with bupivacaine for incisional infiltration in pediatric abdominal operations.
详细描述
Wound infiltration with local anaesthetics is a simple, effective and inexpensive means of providing good analgesia for a variety of surgical procedures without any major side-effects.
Patients and Methods Type of Study:Randomized, controlled, double-blind study.
Study Setting: Ain Shams university hospitals.
Study Period: 3months after approval of the ethical committee.
Study Population:
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, Investigator)
盲法说明
Both the patient and the attending anesthesiologist will be blinded to the drugs injected (a randomized, controlled, double blind study)
入排标准
- 年龄范围
- 1 Year 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of both sexes aged 1-8 years, ASA I-II, undergoing moderate to major abdominal operations.
排除标准
- •History of diabetes, cardiac or neurological disease
- •Hypersensitivity to any of the drugs used in the study.
- •Risk of wound complications ( as infected wound, history of wound dehiscence, hypo--albuminaemia)
- •Multiple incision sites
研究组 & 干预措施
Group 1
Control Group (Bupivacaine 0.25% 1ml/kg will be injected subcutaneously by the surgeon before wound closure).
干预措施: Bupivacaine (Drug)
Group 2
Ketamine Group (In addition to bupivacaine, ketamine 1mg/kg diluted in 10 ml normal saline will be injected subcutaneously by the surgeon before wound closure. Bupivacaine and ketamine will be administered using two separate syringes).
干预措施: Bupivacaine (Drug)
Group 2
Ketamine Group (In addition to bupivacaine, ketamine 1mg/kg diluted in 10 ml normal saline will be injected subcutaneously by the surgeon before wound closure. Bupivacaine and ketamine will be administered using two separate syringes).
干预措施: Ketamine (Drug)
Group 3
Dexamethasone Group (In addition to bupivacaine, dexamethasone 0.2mg/kg diluted in 10 ml normal saline will be injected subcutaneously by the surgeon before wound closure. Bupivacaine and dexamethsone will be administered using two separate syringes).
干预措施: Bupivacaine (Drug)
Group 3
Dexamethasone Group (In addition to bupivacaine, dexamethasone 0.2mg/kg diluted in 10 ml normal saline will be injected subcutaneously by the surgeon before wound closure. Bupivacaine and dexamethsone will be administered using two separate syringes).
干预措施: Dexamethasone (Drug)
结局指标
主要结局
The Face, Leg, Activity, Cry and Consolability scale (FLACC) pain scale
时间窗: At 24 hours postoperatively
Face: No particular expression or smile (0) Occasional grimace or frown, withdrawn, disinterested (1) Frequent to constant frown, clenched jaw, quivering chin (2) -Legs: Normal position or relaxed (0) Uneasy, restless, tense (1) Kicking, legs drawn up (2) -Activity: Lying quietly, normal position, moves easily (0) Squirming, shifting back and forth, tense (1) Arched, rigid or jerking (2) -Cry: No crying (awake or asleep) (0) Moans or whimpers, occasional complaint (1) Crying steadily, screamsor sobs, frequent complaints (2) -Consolability: Content, relaxed (0) Reassured by occasional touching, hugging or talking to, distractable (1) Difficult to console or comfort (2) The scale range from 0 to 10. The higher the number the worse the pain status.
Rescue analgesia
时间窗: 24 hours
Time needed for first rescue analgesia
Total dose of rescue analgesia in the first 24 hours postoperatively.
时间窗: 24 hours
Total dose of rescue analgesia in the first 24 hours postoperatively. If pain persisted or recurred rectal diclophenac 1mg/kg. total dose measured in milligrams
次要结局
- Incidence of wound complications(72 hours)
- Incidence of postoperative nausea and vomiting(24 hours)
研究者
Diaaeldein Mahmoud Haiba
Lecturer of Anesthesia, ICU & Pain management, Faculty of medicine
Ain Shams University