Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-01-15
2021-01-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Acupuncture
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
Acupuncture
Application of acupuncture
Standard care group
The patients will follow the standard procedure
No interventions assigned to this group
Interventions
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Acupuncture
Application of acupuncture
Eligibility Criteria
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Inclusion Criteria
2. American Society of Anesthesiologist (ASA) physical status I or II
Exclusion Criteria
2. Neurological disorders (development delay)
2 Years
12 Years
ALL
No
Sponsors
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IRCCS Burlo Garofolo
OTHER
Responsible Party
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Principal Investigators
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Silvia Tisato, MD
Role: PRINCIPAL_INVESTIGATOR
Institute for Maternal and Child Health IRCCS Burlo Garofolo
Locations
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Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, , Italy
Countries
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Other Identifiers
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RC 33/2020
Identifier Type: -
Identifier Source: org_study_id
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