Acupuncture in Emergency Delirium After Tonsillectomy

NCT04693390 | Withdrawn

• 1 other identifier: RC 33/2020
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Delirium

Keywords

Acupuncture; Emergency Delirium; Tonsillectomy

Outcome Measures

Primary Outcomes (1)

• Postoperative agitation evaluated with the PAED scale

  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.

  Within 5 minutes from arrival in the post anesthesia care unit

Secondary Outcomes (9)

• Postoperative agitation evaluated with the PAED scale

  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

• Postoperative agitation evaluated with the Watcha Scale

  30 minutes after the arrival in the post anesthesia care unit

• Postoperative agitation evaluated with the Cravero scale

  30 minutes after the arrival in the post anesthesia care unit

Study Arms (2)

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

Procedure: Acupuncture

Standard care group

NO INTERVENTION

The patients will follow the standard procedure

Interventions

Acupuncture PROCEDURE

Application of acupuncture

Acupuncture

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Trieste, 34137, Italy

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Silvia Tisato, MD

  Institute for Maternal and Child Health IRCCS Burlo Garofolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: January 15, 2021
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

IT (1)