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Acupuncture in Emergency Delirium After Tonsillectomy

I

IRCCS Burlo Garofolo

Status

Withdrawn

Conditions

Emergence Delirium

Treatments

Procedure: Acupuncture

Study type

Interventional

Funder types

Other

Identifiers

NCT04693390
RC 33/2020

Details and patient eligibility

About

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.

Sex

All

Ages

2 to 12 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

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

Exclusion criteria

  1. Coagulation disorders (pro-hemorrhagic status)
  2. Neurological disorders (development delay)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

0 participants in 2 patient groups

Acupuncture
Experimental group
Description:
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
Treatment:
Procedure: Acupuncture
Standard care group
No Intervention group
Description:
The patients will follow the standard procedure

Trial contacts and locations

1

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Central trial contact

Silvia Tisato, MD; Silvia Tisato, MD

Data sourced from clinicaltrials.gov

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