Clinical trial NCT04693390: Acupuncture in Emergency Delirium After Tonsillectomy
Official title: Acupuncture Management of Emergence Agitation in Children Undergoing Tonsillectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Emergence Delirium
Keywords: Acupuncture
Emergency Delirium
Tonsillectomy
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: Postoperative agitation evaluated with the PAED scale
timeFrame: Within 5 minutes from arrival in the post anesthesia care unit
Secondary outcomes:
measure: Postoperative agitation evaluated with the PAED scale
timeFrame: 30 minutes after the arrival in the post anesthesia care unit
measure: Postoperative agitation evaluated with the Watcha Scale
timeFrame: Within 5 minutes from arrival in the post anesthesia care unit
measure: Postoperative agitation evaluated with the Cravero scale
timeFrame: Within 5 minutes from arrival in the post anesthesia care unit
measure: Postoperative agitation evaluated with the Watcha Scale
timeFrame: 30 minutes after the arrival in the post anesthesia care unit
measure: Postoperative agitation evaluated with the Cravero scale
timeFrame: 30 minutes after the arrival in the post anesthesia care unit
measure: Pain evaluated with the FLACC scale
timeFrame: Within 5 minutes from arrival in the post anesthesia care unit
measure: Pain evaluated with the FLACC scale
timeFrame: 30 minutes after the arrival in the post anesthesia care unit
measure: Unintended harm caused by patients agitation
timeFrame: Within 5 minutes from arrival in the post anesthesia care unit
measure: Unintended harm caused by patients agitation
timeFrame: 30 minutes after the arrival in the post anesthesia care unit
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Study officials:
affiliation: Institute for Maternal and Child Health IRCCS Burlo Garofolo
name: Silvia Tisato, MD
role: PRINCIPAL_INVESTIGATOR
References: