跳至主要内容
临床试验/NCT04693390
NCT04693390撤回不适用

Acupuncture Management of Emergence Agitation in Children Undergoing Tonsillectomy: a Randomized Controlled Trial

IRCCS Burlo Garofolo1 个研究点 分布在 1 个国家开始时间: 2021年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Postoperative agitation evaluated with the PAED scale

研究概览

简要总结

Emergence delirium (ED) (also called emergence agitation) can be defined as a "dissociated state of consciousness in which the child is irritable, uncompromising, uncooperative, incoherent and inconsolable crying, moaning, kicking or thrashing".

Tonsillectomy (with or without adenoidectomy) is a routinely performed operation. Emergence agitation is a frequent phenomenon in children recovering from general anesthesia for tonsillectomy, and increases risk of self-injury. It's not unusual for the post-anesthesia care unit (PACU) staff look that a child, who was asleep just minutes before, starts screaming, pulling out his intravenous line, looks like he's about to fall out of his bed. This condition requires sedatives that may cause undesirable side effects. The cause of emergence delirium and the mechanism of agitation following general anesthesia is unknown. Probably the volatile agents work on some pathways, possibly in the locus coeruleus or amygdala, in the setting of a specific neurodevelopmental stage of the brain.

While emergence delirium can be seen into adulthood, its peak incidence is in younger children (2-7 years of age). The incidence of ED is unclear: anywhere from 2-80%, but when confounders like pain, nausea etc. are controlled, the incidence is probably around 20-30%.

Limited data suggest that acupuncture may be a safe, nonpharmacological treatment for the reduction of pain and agitation in term and preterm infants and that may be an alternative method for preventing ED. In particular a prospective, randomized, double-bind controlled study demonstrated a reduction of the ED in many surgeries, after the electrical stimulation of the heart 7 acupuncture site.

Nearly 400 acupuncture points are known on the body surface and they belong to 14 meridians, running along the human body. After the needle peeling, the nervous free terminations release some polypeptid (the most important is the substantia P) and it increases the excitability of the near nervous free terminations which cause vasodilatation. It has a myorelaxant effect, decreases the level for pain tolerance and make stronger the inhibitor effect of descendent fibers, with production of endogenous endorphins. This is the reason why acupuncture is considered valid in prevention and control of ED.

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
Single (Participant)

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

  • •Children scheduled to undergo tonsillectomy with or without adenoidectomy
  • •American Society of Anesthesiologist (ASA) physical status I or II

排除标准

  • •Coagulation disorders (pro-hemorrhagic status)
  • •Neurological disorders (development delay)

研究组 & 干预措施

Acupuncture

Experimental

The acupuncture will be applied at points LI4, ST36, HT7, in association with auriculotherapy point Master Cerebral, immediately after induction of anesthesia for 20 minutes

干预措施: Acupuncture (Procedure)

Standard care group

No Intervention

The patients will follow the standard procedure

结局指标

主要结局

Postoperative agitation evaluated with the PAED scale

时间窗: Within 5 minutes from arrival in the post anesthesia care unit

Between groups difference in postoperative agitation assessed by the health personnel with the Pediatric Anesthesia Emergence Delirium (PAED) scale. PAED consists of 5 psychometric items describing emergence behavior, with score ranging from 0 to 20. The severity of ED increases with a higher score. Scores ≥10 indicate the presence of ED.

次要结局

  • Postoperative agitation evaluated with the Cravero scale(30 minutes after the arrival in the post anesthesia care unit)
  • Postoperative agitation evaluated with the Watcha Scale(30 minutes after the arrival in the post anesthesia care unit)
  • Pain evaluated with the FLACC scale(30 minutes after the arrival in the post anesthesia care unit)
  • Postoperative agitation evaluated with the PAED scale(30 minutes after the arrival in the post anesthesia care unit)
  • Unintended harm caused by patients agitation(30 minutes after the arrival in the post anesthesia care unit)
  • Postoperative agitation evaluated with the Watcha Scale(Within 5 minutes from arrival in the post anesthesia care unit)
  • Postoperative agitation evaluated with the Cravero scale(Within 5 minutes from arrival in the post anesthesia care unit)
  • Pain evaluated with the FLACC scale(Within 5 minutes from arrival in the post anesthesia care unit)
  • Unintended harm caused by patients agitation(Within 5 minutes from arrival in the post anesthesia care unit)

研究者

发起方
IRCCS Burlo Garofolo
申办方类型
Other
责任方
Sponsor

研究点 (1)

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