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临床试验/NCT06779396
NCT06779396招募中4 期

Pre-emptive Scalp Infiltration with Triamcinolone Acetonide Plus Ropivacaine for Post-Craniotomy Pain in Children

Beijing Tiantan Hospital1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2025年1月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
128
试验地点
1
主要终点
the Faces, Legs, Activity, Cry, Consolability (FLACC) scale

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.However, there has not been reported about local application of triamcinolone acetonide on scalp infiltration. Thus, the investigators suppose that pre-emptive scalp infiltration with steroid (triamcinolone acetonide) 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
Randomized
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

  • •(1) Age 2 to 12 years. (2) American Society of Anesthesiologists (ASA) physical status I or II. (3)Participates with an anticipated fully recovery within 2 hours postoperatively.
  • •(4)Informed consent by parent(s) and/or legal guardian.

排除标准

  • •(1) Allergy to local anesthetics. (2) Pediatric patients aged>12 or <2 years. (3) Under medication with analgesic drugs. (4) Psychiatric disorders. (5) Uncontrolled epilepsy. (6) Chronic headache. (7) Peri-incisional infection. (8) Coagulopathy or bleeding disorder. (9) Patients who are expected to remain intubated and mechanical ventilation after surgery.
  • •(10) Emergency craniotomies. (11) Patients with cardiac insufficiency or severe kidney or liver diseases. (12) Patients whose authorized surrogates are unwilling to participate in the study

研究组 & 干预措施

Experimental: The triamcinolone acetonide plus ropivacaine group

Experimental

Patients in the triamcinolone acetonide plus ropivacaine group will receive a peri-incisional scalp infiltration with 0.2% ropivacaine(40mg) and 4 mg of triamcinolone acetonide and normal saline miscible liquids.

干预措施: The triamcinolone acetonide plus ropivacaine group (Drug)

Active Comparator: The ropivacaine group

Active Comparator

Patients in the ropivacaine group will receive a peri-incisional scalp infiltration 0.2% ropivacaine(40mg)

干预措施: The ropivacaine group (Drug)

结局指标

主要结局

the Faces, Legs, Activity, Cry, Consolability (FLACC) scale

时间窗: At 24 hours after the operation

Postoperative pain will be estimated by usingthe Faces, Legs, Activity, Cry, Consolability (FLACC) scale score at 24 hours postoperatively.

次要结局

  • The total consumption of opioids during the operation(During procedure)
  • the Faces, Legs, Activity, Cry, Consolability (FLACC) scale(At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery)
  • Duration of analgesia(Within 48 hours after the operation)
  • The occurrence of postoperative nausea and vomiting (PONV)(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)
  • Patient satisfactory scale (PSS)(At 2 hours, 4 hours, 8 hours, 48 hours, 72 hours, 1 week after surgery)

研究者

发起方
Beijing Tiantan Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fang Luo

Director of Department of Pain Management

Beijing Tiantan Hospital

研究点 (1)

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