Acupuncture in Emergency Delirium After Tonsillectomy

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04693390
Study type	Interventional
Source	IRCCS Burlo Garofolo
Contact
Status	Withdrawn
Phase	N/A
Start date	January 15, 2021
Completion date	January 15, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03787849` - Epigenetics in PostOperative Pediatric Emergence Delirium	N/A
Completed	`NCT03788564` - The Association of Cardiac Ion Channel Related Gene Polymorphism and Prolonged QTc Interval After Endotracheal Intubation
Recruiting	`NCT01221025` - Effect Study of Parecoxib to Treat Emergence Delirium and Postoperative Pain	Phase 4
Not yet recruiting	`NCT06035757` - The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery	Phase 4
Not yet recruiting	`NCT04291820` - Impact of Anaesthesiology Management on Paediatric Emergence Delirium Incidence	N/A
Completed	`NCT05124067` - Effect of Dexmedetomidine on Prevention of Postoperative Nausea and Vomiting in Children	Phase 1
Recruiting	`NCT05091242` - The PREVENT AGITATION Trial II - Children ≤1 Year	Phase 2/Phase 3
Completed	`NCT03330236` - EEG - Guided Anesthetic Care and Postoperative Delirium	N/A
Completed	`NCT04531020` - Incidence of Emergence Delirium in the PACU
Completed	`NCT05105178` - Verbal Stimulation of Orientation on Emergence Agitation	N/A
Completed	`NCT03285243` - Effect of Monochromatic Light on Incidence of Emergence Delirium in Children	N/A
Recruiting	`NCT04621305` - Remimazolam Reduces Emergence Delirium in Preschool Children Undergoing Laparoscopic Surgery by Sevoflurane Anesthesia	Phase 4
Completed	`NCT01096797` - Correlation Between Pain and Emergence Delirium After Adenotonsillectomy in Preschool Children	Phase 4
Recruiting	`NCT03330613` - Emergence Delirium and Recovery Time in Children	N/A
Completed	`NCT05872087` - Comparative Study Between Nebulised Dexmedetomidine and Nebulised Midazolam in Children Undergoing Lower Abdominal Surgeries	Phase 1
Recruiting	`NCT06326983` - Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery	N/A
Not yet recruiting	`NCT06387953` - Mitigation of Emergence Agitation Through Implementation of Masimo Bridge Therapy	N/A
Not yet recruiting	`NCT06406257` - Temperature Management on Postoperative Delirium	N/A
Not yet recruiting	`NCT05883280` - The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery	N/A
Not yet recruiting	`NCT05821972` - Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.