Pre-emptive Infiltration of the Scalp with Diprospan Plus Ropivacaine for Pain After Craniotomy in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS)
研究概览
简要总结
At present, pediatric postoperative analgesia has not been fully understood and controlled, particularly craniotomy surgery. On the one hand, professional evaluation of postoperative pain for young children is difficult; on the other hand, the particularity of craniotomy adds (such as consciousness obstacle, sleepiness, et al) disturbance to the pain assessment in children. Although opioids administration is regarded as the first-line analgesic for post-craniotomy pain management, it may be associated with delayed awakening, respiratory depression, hypercarbia and it may interfere with the neurologic examination. For the avoidance of side-effects of systemic opioids, local anesthetics administered around the incision have been performed clinically. However, some studies revealed that the analgesic effect of local anesthetics was unsatisfactory due to its short pain relief duration, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. As is reported that postoperative pain of craniotomy is mainly caused by skin incision and reflection of muscles, preventing the liberation of inflammatory mediators around the incision seems to be more effective than simply blocking nerve conduction. Researchers have clarified that the addition of diprospan to local infiltration of analgesia could provide significant analgesic effects and significantly prolong the duration of analgesic effects without obvious complications for various types of surgeries. To date, no studies have evaluated the addition of diprospan to local infiltration for patients receiving craniotomy.
Thus, investigators suppose that pre-emptive scalp infiltration with steroid (Diprospan) plus local anesthetic (ropivacaine) could relieve postoperative pain after craniotomy in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An elective craniotomy under general anesthesia; American Society of Anesthesiologists (ASA) physical status of I or II; Participates with an anticipated fully recovery within 2 hours postoperatively; Informed consent by parent(s) and/or legal guardian.
排除标准
- •History of allergies to any of the study drugs; Drugs with confirmed or suspected sedative or analgesic effects; receiving any painkiller within 24 h before surgery; children who received steroids; Psychiatric disorders; Uncontrolled epilepsy; Chronic headache; Peri-incisional infection; Body mass index exceeded the 99th percentile for age; Children who must use a patient-controlled analgesia (PCA) device; Children who cannot understand an instruction of pain scales before surgery
研究组 & 干预措施
The diprospan plus ropivacaine group
Patients in the diprospan plus ropivacaine group will receive a peri-incisional scalp infiltration with 15ml diprospan and 15mg of 1% ropivacaine and normal saline miscible liquids.
干预措施: The diprospan plus ropivacaine group (Drug)
The ropivacaine group
Patients in the ropivacaine group will receive a peri-incisional scalp infiltration with 15mg of 1%
干预措施: The ropivacaine group (Drug)
结局指标
主要结局
modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS)
时间窗: At 24 hours after the operation
Postoperative pain will be estimated by using the modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS). 0 indicates no pain, 10 indicates the most severe pain imaginable.
次要结局
- modified Children's Hospital of Eastern Ontario Pain Scale (mCHEOPS)(At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery)
- Patient satisfactory scale (PSS)(At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery)
- The time to the first rescue analgesic(Within 48 hours after the operation)
- Length of stay (LOS)(Approximately 1 weeks after the operation)
- The occurrence of respiratory depression(Within 48 hours after the operation)
- The total consumption of opioids during the operation(During procedure)
- The occurrence of postoperative nausea and vomiting (PONV)(At 2 hours, 4 hours, 8 hours, 24 hours after surgery)
- Ramsay Sedation Scale (RSS)(At 2 hours, 4 hours, 8 hours, 24 hours after surgery)
- Heart rate(During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery)
- The total consumption of anaesthetic during the operation(During procedure)
- Wound Healing Score(At 1 month after surgery)
- Mean arterial pressure(During the operation and at 2 hours, 4 hours, 8 hours, 24 hours after surgery)
- Incisional related adverse events(Approximately 1 weeks after the operation)
- The occurrence of the Adverse events (AEs) and serious adverse events (SAEs)(Within 1 weeks after the operation)
研究者
Fang Luo
Director of Department of Pain Management
Beijing Tiantan Hospital
