Preemptive Local Anesthetic Infiltration Reduces Opioid Requirements Without Attenuation of the Intraoperative Evoked Stapedial Reflex Thresholds in Pediatric Cochlear Implant Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- number of patients requiring rescue opioid analgesia (Tramal)
研究概览
简要总结
Propofol with remifentanil provides good operative conditions for pediatric cochlear implant (CI); however, large doses of remifentanil usually result in postoperative hyperalgesia and increase postoperative pain. Local anesthesia (LA) is commonly used as an adjunct to general anesthesia in children; however, otologists are usually reluctant in the use of LA as it can cause abolishment of the electrical stapedial reflex threshold (ESRT).
详细描述
Seventy children (1-6 years) undergoing CI were recruited. Children were divided into two groups. The LA group received subcutaneous infiltration of 0.5 ml/kg lidocaine 1% in adrenaline 1:200,000 and the CT group received 0.5 ml/kg of Na CI 0.9% in adrenaline 1:200,000. The primary outcome was number of patients requiring rescue analgesia (tramadol) during the first 24-h postoperative. Secondary outcomes were haemodynamic variables, the ESRT, intraoperative anesthetic requirements, time to LMA removal, time to total recovery, pain scores, time to first rescue analgesia and incidence of vomiting.
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
- Double (Participant, Care Provider)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I-II physical status,
- •age between 1 and 6 year,
排除标准
- •known allergy to local anesthetics,
- •predicted operative difficulty (i.e. syndromic hearing loss, congenital cochlear abnormalities or cochlear ossification.
研究组 & 干预措施
Lidocaine 1%/Epi 1:200000
Subcutaneous infiltration of Lidocaine 1%/Epi 1:200000
干预措施: Lidocaine 1%/Epi 1:200000 (Drug)
Na Cl 0.9%/Epi 1:200000
Subcutaneous infiltration of Na Cl 0.9%/Epi 1:200000
干预措施: Na Cl 0.9%/Epi 1:200000 (Other)
结局指标
主要结局
number of patients requiring rescue opioid analgesia (Tramal)
时间窗: During the length of hospital stay post surgery (on average 24 hours)
Post-operative Pain assessed by the pediatric observational Faces, Legs, Activity, Cry Consolability (FLACC) score with its 0 to 10 score range: (0 (no pain) to 10 ( Severe pain)
次要结局
- The anesthesia time.(Intraoperative)
- mean arterial blood pressure(Intraoperative)
- ESRT responses(Intraoperative)
- Heart rate(Intraoperative)
- The operative time(Intraoperative)
- Anesthetic consumption(Intraoperative)
研究者
Wahba bakhet
Lecturer, Ain shams university
Ain Shams University