Intraperitoneal Dexmedetomidine as an Adjuvant to Bupivacaine for Management of Pain in Children Undergoing Laparoscopic Appendicectomy: A Prospective Randomized Trial
试验速览
- 阶段
- 4 期
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Postoperative abdominal and/or shoulder VAS pain score
研究概览
简要总结
Fifty two children of American Society of Anesthesiologists (ASA) physical status I and II, aged 8-14 years old, of both gender, with suspected acute appendicitis scheduled for laparoscopic appendicectomy, were included in this study. Patients were randomized into group (B) and group (BD) with a 1:1 allocation ratio.At the end of surgery, and after peritoneal lavage, those patients who were allocated to B group (bupivacaine group; n = 26) received bupivacaine 0.25% intraperitoneally at a dose of 2 mg/kg followed by 5 ml normal saline. However, in group BD (bupivacaine, Dexmedetomidine group; n = 26), bupivacaine 0.25% at a dose of 2mg/kg was instilled intraperitoneally followed by dexmedetomidine 1mcg/kg diluted in 5 ml normal saline. In the postoperative period, assessments were made for pain and sedation on awakening in PACU (0 time) and at 2, 4, 6, 12,and 24 h. Abdominal and/or shoulder pain was assessed on the 10-cm Visual Analog Scale (VAS). Sedation was assessed using the Ramsay sedation score. Also the occurrence of nausea or vomiting was recorded . The time from extubation to the first administration of pethidine was registered. The consumption of postoperative analgesia was recorded. Side effects of the study drugs were assessed and recorded by the ward nurses for 24h postoperatively. Possible complications such as respiratory depression, allergic reactions, local anaesthetic toxicity,dizziness, , headache, were recorded and managed accordingly. Duration of surgery and length of stay in PACU were noted. Before discharge to home, length of stay in the hospital was recorded and parent's satisfaction was assessed using the 7-point Likert scale
详细描述
A written informed consent for participation in the trial was obtained by parents or the legal guardians . Fifty two children participate in the study.
Randomization and blindness: Patients were randomized into group (B) and group (BD) with a 1:1 allocation ratio. The allocated intervention was written on a slip of paper, placed in a sealed serially numbered, opaque envelopes. The envelopes were serially opened, and the allocated intervention was implemented. Patients were equally distributed in both groups. All investigators, parents, and patients were blind to which method was being used.
Study description:
On arrival to the operating room, routine preoperative evaluation was performed, and the procedure was explained to all parents. Before premedication, patients and parents were instructed in the use of the 10-cm Visual Analog Scale (VAS),with score raging from 0 (no pain) to 10 (worst pain imaginable). Baseline measurements of heart rate (HR), mean arterial pressure (MAP), respiratory rate (RR), and room air oxygen saturation (SaO2) were obtained using an electrocardiogram, a "Dinamap" automated blood pressure monitor, and a pulse oximeter, respectively.
All children received premedication with midazolam 0.05 mg/kg intravenously afterward, Ringer's lactate infusion (20 ml/kg/h) was started. Standardized prophylactic antiemetic was iv ondansetron 0.15 mg/kg. General anesthesia was inducted with propofol 2 mg/kg, rocuronium 0.6 mg/kg, and fentanyl 2 mcg/kg intravenously (i.v.). Endotracheal intubation was performed, tube size was calculated according to the formula: age/4+4. Anesthesia was maintained with a sevoflurane and oxygen mixture, with total fresh gas flow 3 L/min controlled by mechanical ventilation, tidal volume 5-10 ml/kg. The respiratory rate adjusted according to the end tidal CO2 (maintaining CO2 in the normal range of 35-45 mmHg). Standardized prophylactic antiemetic was ondansetron 0.15 mg/kg.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are of American Society of Anesthesiologists (ASA) physical status I and II, aged 8-14 years old, of both gender, with suspected acute appendicitis scheduled for laparoscopic appendicectomy.
排除标准
- •The diagnosis of developmental delay, attention deficit disorder, chronic pain, psychiatric illness, previous open abdominal surgery, the presence of a gastrostomy, ventricular-peritoneal shunt or other abdominal prosthesis, immunosuppression, and those allergic to any of the medications.
研究组 & 干预措施
Bupivacaine group
intraperitoneal instillation of bupivacaine 0.25% ( 2mg/kg) after excision of the appendix.
干预措施: Bupivacaine (Drug)
Bupivacaine-Dexmedetomidine group
intraperitoneal instillation of bupivacaine 0.25% ( 2mg/kg) plus dexmedetomidine 1mcg/kg after excision of the appendix.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Postoperative abdominal and/or shoulder VAS pain score
时间窗: at the start of postanesthesia care unit (PACU)(0 time), and 2 Hours, 4 Hours, 6 Hours, 12 Hours, and 24 Hours postoperative
assessment of changes in pain scores along different time intervals in the postoperative 24 hours
次要结局
- Time of first request of analgesia.(from the start of postanesthesia care unit (PACU time) and up to 8 hours)
- amount of rescue pethidine consumed(in 24 Hours postoperative)
- Length of hospital stay(from end of surgery till discharge to home, up to one week)
- Sedation score(at the start of postanesthesia care unit (PACU)(0 time), and 2 Hours, 4 Hours, 6 Hours, 12 Hours, and 24 Hours postoperative)
研究者
Ali Elnabtity
Principal investigator
Zagazig University