Effects of Perioperative Administration of Intravenous Lidocaine in Children Operated on for Acute Generalized Peritonitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
- 主要终点
- Resumption of transit
研究概览
简要总结
Intravenous administration of lidocaine perioperatively after laparotomy for peritonitis could be an interesting alternative by reducing the duration of postoperative ileus, the intensity of pain and the patient's hospital stay, as well as the cost of management in our context of lack of financial, technical and human resources, hence the present study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 6 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients aged 6 to 15, Classified according to the American Society of Anaesthesiologists (ASA) (I, II and III) admitted for peritonitis and whose parents have given informed consent
排除标准
- •State of shock
- •Severe renal insufficiency (creatinine clearance less than 30 ml/min)
- •History of allergy to lidocaine
- •Refusal to participate in the study
研究组 & 干预措施
Lidocaine group
The group will receive 1.5 mg/kg lidocaine 2% bolus, followed by a continuous electric syringe dose of 1.5 mg/kg/hour intraoperatively, then 1.5 mg/kg/hour during the first 24 hours postoperatively
干预措施: Lidocaine intravenous (Drug)
Saline group
The control group will receive an equivalent volume of saline: the volume of saline to be administered will be obtained by considering the dose of lidocaine 2% that the patient would have received if he/she had been in the interventional group.
干预措施: Serum saline intravenous (Drug)
结局指标
主要结局
Resumption of transit
时间窗: Up to 7 days during the postoperative period. From the date of randomization to the first postoperative gas and/or the presence of postoperative bowel sounds in the patient
time to first gas and/or presence of bowel sounds
次要结局
- Analog visual scale(Postoperative pain scores at 24 hours)
- Postoperative mortality(Up to 30 days during the postoperative period. From date of randomization to date of death)
- Hospitalisation(Up to 30 days during the postoperative period. From the date of randomization to the patient's discharge from hospital or date of death)
- Concentration of C-reactive protein(Hours 24 postoperative)
研究者
Ismael Guibla
Principal investigator, Clinical doctor
Université NAZI BONI