Intravenous Versus Caudal Magnesium Sulfate as an Adjuvant to Caudal Bupivacaine in Lower Abdominal Surgeries in Paediatrics Under General Anaesthesia
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 主要终点
- The analgesic effect of intravenous magnesium in children undergoing lower abdominal surgeries
研究概览
简要总结
Intravenous magnesium has been studied in pediatrics to reduce agitation after sevoflurane anesthesia in children undergoing adenotonsillectomy, reduce intraoperative rocuronium requirements, prevent laryngospasm and coughing after removal of the endotracheal tube in patients undergoing adenotonsillectomy.
The aim of this study is to investigate the role of intravenous magnesium sulfate on postoperative pain management in paediatrics and to compare it with its effect when administered caudally in children undergoing lower abdominal surgeries.
详细描述
Postoperative pain in children is difficult to assess and is associated with strong emotional component .
Recently, there is an increasing interest to study magnesium analgesic effects. Magnesium, the fourth most common cation in the body, inhibits calcium entry into the cell via a noncompetitive blockade of the N-methyl-d-aspartate (NMDA) receptors. Magnesium and the NMDA receptors are thought to be involved in the modulation of pain. Magnesium is also a physiological calcium antagonist at different voltage-gated channels, which may be important in the mechanisms of antinociception.
As a NMDA antagonist, magnesium prevents the central sensitization from nociceptive stimulation. Many studies suggested that epidurally administered magnesium as an adjuvant could reduce the postoperative pain in adults. But few studies are available about the use of magnesium as an adjuvant in caudal block for postoperative analgesia in pediatrics.
The aim of this study is to investigate the role of intravenous magnesium sulfate on postoperative pain management in paediatrics and to compare it with its effect when administered caudally in children undergoing lower abdominal surgeries.
Objectives
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 1 Year 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 1 and 7 years, ASA(American Society of Anesthesiologists) physical status class |- || , patients scheduled for lower abdominal surgeries.
排除标准
- •patients with psychiatric disorders , children with cardiovascular,respiratory ,hepatic or renal dysfunction , known contraindications to regional anesthesia, ASA class |||- |V, hypersensitivity to magnesium or regular analgesic drugs.
研究组 & 干预措施
Intravenous magnesium group (Group IV)
Group IV (n=30) will receive intravenous (IV) 20 ml magnesium SO4 (50 mg/ kg 10% MgSO4(magnesium sulphate) diluted in normal saline to a total volume of 20 ml(milliliter) ) and caudal anaesthesia using (bupivacaine 0.25% diluted in normal saline with total volume of 1 mL/kg) .
干预措施: Magnesium SO4 (Drug)
Caudal magnesium group (Group CA)
Group CA (n=30) will receive IV 20 ml normal saline and caudal anaesthesia using (bupivacaine 0.25% and 50 mg Magnesium SO4 diluted in normal saline with total volume of 1mL/kg).
干预措施: Magnesium SO4 (Drug)
Placebo group (Group P)
Group P (n=30) ) will receive IV 20 ml normal saline and caudal anaesthesia using (bupivacaine 0.25% diluted in normal saline with total volume of 1 mL/kg).
干预措施: Magnesium SO4 (Drug)
结局指标
主要结局
The analgesic effect of intravenous magnesium in children undergoing lower abdominal surgeries
时间窗: 12 hours
Post operative pain score will be assessed using children's Hospital of Eastern Ontario Pain scale which is based on 6 criteria: * Crying * Facial expression * Child verbal expression * Torso (body position) * Touching or grabbing at wound * Legs position Criterion 1 is given a score of 1-3, criterion 2 and 3 are given a score of 0-2 while criterion 4, 5 and 6 are given a score of 1-2; making the worst possible score 13 while the least possible score is 4. A total score ≤ than 8 indicate adequate analgesia.
次要结局
- Time to first rescue analgesia(12 hours)
- Post operative sedation score(30 minutes)
研究者
Magda saleh rezk
Assistant lecturer, anesthesia department,Cairo University
Cairo University