Dexmedetomidine Versus Magnesium Sulfate as an Adjuvant to Intraperitoneal Bupivacaine for Pain Relief in Children Undergoing Laparoscopic Herniorrhaphy: a Randomized Controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
It is important to keep children undergoing laparoscopic surgery pain free with rapid return to normal activity.
详细描述
Pain following laparoscopy is less intense than after laparotomy. Nevertheless, laparoscopy is not pain free and control of post-laparoscopy pain remains a major concern. The exact cause of such pain remains uncertain, and yet, diaphragmatic irritation and peritoneal stretching associated with gas insufflation may be responsible for shoulder and diffuse abdominal pain.
additionally poor pain control could limit the activity of children following laparoscopic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •age (1 to 6 years)
- •ASA physical status I or II.
- •scheduled for laparoscopic hernia repair under general anesthesia.
排除标准
- •Allergy to study drugs,
- •Receiving chronic pain treatment, antiepileptic therapy or magnesium therapy,
- •sever hepatic or renal impairment,
研究组 & 干预措施
Dexmedetomidine
2 mg/kg bupivacaine 0.5% and 1 ug/kg of dexamedetomidine diluted in normal saline 0.9 % will instilled into the peritoneal cavity
干预措施: Dexmedetomidine (Drug)
Magnesium sulfate
2 mg/kg bupivacaine 0.5% and 30 mg/kg of magnesium sulfate diluted in normal saline 0.9 % will instilled into the peritoneal cavity
干预措施: Magnesium Sulfate (Drug)
Control group
2 mg/kg bupivacaine 0.5% diluted in normal saline 0.9 % will instilled into the peritoneal cavity.
干预措施: Normal saline 0.9 % (Drug)
结局指标
主要结局
Postoperative pain
时间窗: 48 hr
The Face Legs Activity Cry and Consolability (FLACC) pain score
次要结局
- the functional recovery(48 hours after surgery)
研究者
Seham Mohamed Moeen Ibrahim
lecturer
Assiut University