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Acupuncture in Emergency Delirium After Tonsillectomy

Primary Purpose

Emergence Delirium

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
IRCCS Burlo Garofolo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Emergence Delirium focused on measuring Acupuncture, Emergency Delirium, Tonsillectomy

Eligibility Criteria

2 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Acupuncture

Standard care group

Arm 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

The patients will follow the standard procedure

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Postoperative agitation evaluated with the PAED scale
Between groups difference in postoperative agitation assessed by the health personnel with 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.
Postoperative agitation evaluated with the Watcha Scale
Between groups difference in postoperative agitation assessed with the Watcha Scale. The Watcha scale is a 4 points scale, describing the behaviour of the patient; a score >2 indicates emergence delirium.
Postoperative agitation evaluated with the Cravero scale
Between groups difference in postoperative agitation assessed with the Cravero emergence agitation scale, consisting of five steps from obtunded and unresponsive to wild thrashing behaviour requiring restraint. A score of 4 (from crying and difficult to console to wild thrashing) for 5 or more minutes is indicative of emergency delirium.
Postoperative agitation evaluated with the Watcha Scale
Between groups difference in postoperative agitation assessed with the Watcha Scale. The Watcha scale is a 4 points scale, describing the behaviour of the patient; a score >2 indicates emergence delirium.
Postoperative agitation evaluated with the Cravero scale
Between groups difference in postoperative agitation assessed with the Cravero emergence agitation scale, consisting of five steps from obtunded and unresponsive to wild thrashing behaviour requiring restraint. A score of 4 (from crying and difficult to console to wild thrashing) for 5 or more minutes is indicative of emergency delirium.
Pain evaluated with the FLACC scale
Between groups difference in pain, evaluated using the Faces, Legs, Activity, Cry and Consolability (FLACC) scale administered by the health personnel. The FLACC tool assesses changes in five categories of behavior (namely: Face, legs, Activity, Crying and Consolability), rating each one on a scale of 0-2. Ten is the maximum score indicating severe pain and a score <2 generally indicates absence of pain. A FLACC score higher than 4 is considered as indicator of moderate pain.
Pain evaluated with the FLACC scale
Between groups difference in pain, evaluated using the FLACC scale administered by the health personnel. The FLACC tool assesses changes in five categories of behavior (namely: Face, legs, Activity, Crying and Consolability), rating each one on a scale of 0-2. Ten is the maximum score indicating severe pain and a score <2 generally indicates absence of pain. A FLACC score higher than 4 is considered as indicator of moderate pain.
Unintended harm caused by patients agitation
Between groups difference in harming surgical repair, harming self or caregivers, pulling out IV's draws or tubes
Unintended harm caused by patients agitation
Between groups difference in harming surgical repair, harming self or caregivers, pulling out IV's draws or tubes

Full Information

First Posted
December 30, 2020
Last Updated
January 5, 2022
Sponsor
IRCCS Burlo Garofolo
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1. Study Identification

Unique Protocol Identification Number
NCT04693390
Brief Title
Acupuncture in Emergency Delirium After Tonsillectomy
Official Title
Acupuncture Management of Emergence Agitation in Children Undergoing Tonsillectomy: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS Burlo Garofolo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium
Keywords
Acupuncture, Emergency Delirium, Tonsillectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm 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
Arm Title
Standard care group
Arm Type
No Intervention
Arm Description
The patients will follow the standard procedure
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Intervention Description
Application of acupuncture
Primary Outcome Measure Information:
Title
Postoperative agitation evaluated with the PAED scale
Description
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.
Time Frame
Within 5 minutes from arrival in the post anesthesia care unit
Secondary Outcome Measure Information:
Title
Postoperative agitation evaluated with the PAED scale
Description
Between groups difference in postoperative agitation assessed by the health personnel with 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.
Time Frame
30 minutes after the arrival in the post anesthesia care unit
Title
Postoperative agitation evaluated with the Watcha Scale
Description
Between groups difference in postoperative agitation assessed with the Watcha Scale. The Watcha scale is a 4 points scale, describing the behaviour of the patient; a score >2 indicates emergence delirium.
Time Frame
Within 5 minutes from arrival in the post anesthesia care unit
Title
Postoperative agitation evaluated with the Cravero scale
Description
Between groups difference in postoperative agitation assessed with the Cravero emergence agitation scale, consisting of five steps from obtunded and unresponsive to wild thrashing behaviour requiring restraint. A score of 4 (from crying and difficult to console to wild thrashing) for 5 or more minutes is indicative of emergency delirium.
Time Frame
Within 5 minutes from arrival in the post anesthesia care unit
Title
Postoperative agitation evaluated with the Watcha Scale
Description
Between groups difference in postoperative agitation assessed with the Watcha Scale. The Watcha scale is a 4 points scale, describing the behaviour of the patient; a score >2 indicates emergence delirium.
Time Frame
30 minutes after the arrival in the post anesthesia care unit
Title
Postoperative agitation evaluated with the Cravero scale
Description
Between groups difference in postoperative agitation assessed with the Cravero emergence agitation scale, consisting of five steps from obtunded and unresponsive to wild thrashing behaviour requiring restraint. A score of 4 (from crying and difficult to console to wild thrashing) for 5 or more minutes is indicative of emergency delirium.
Time Frame
30 minutes after the arrival in the post anesthesia care unit
Title
Pain evaluated with the FLACC scale
Description
Between groups difference in pain, evaluated using the Faces, Legs, Activity, Cry and Consolability (FLACC) scale administered by the health personnel. The FLACC tool assesses changes in five categories of behavior (namely: Face, legs, Activity, Crying and Consolability), rating each one on a scale of 0-2. Ten is the maximum score indicating severe pain and a score <2 generally indicates absence of pain. A FLACC score higher than 4 is considered as indicator of moderate pain.
Time Frame
Within 5 minutes from arrival in the post anesthesia care unit
Title
Pain evaluated with the FLACC scale
Description
Between groups difference in pain, evaluated using the FLACC scale administered by the health personnel. The FLACC tool assesses changes in five categories of behavior (namely: Face, legs, Activity, Crying and Consolability), rating each one on a scale of 0-2. Ten is the maximum score indicating severe pain and a score <2 generally indicates absence of pain. A FLACC score higher than 4 is considered as indicator of moderate pain.
Time Frame
30 minutes after the arrival in the post anesthesia care unit
Title
Unintended harm caused by patients agitation
Description
Between groups difference in harming surgical repair, harming self or caregivers, pulling out IV's draws or tubes
Time Frame
Within 5 minutes from arrival in the post anesthesia care unit
Title
Unintended harm caused by patients agitation
Description
Between groups difference in harming surgical repair, harming self or caregivers, pulling out IV's draws or tubes
Time Frame
30 minutes after the arrival in the post anesthesia care unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Children scheduled to undergo tonsillectomy with or without adenoidectomy American Society of Anesthesiologist (ASA) physical status I or II Exclusion criteria Coagulation disorders (pro-hemorrhagic status) Neurological disorders (development delay)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Tisato, MD
Phone
00390403785111
Email
silvia.tisato@burlo.trieste.it
First Name & Middle Initial & Last Name or Official Title & Degree
Silvia Tisato, MD
Phone
00390403785111
Email
siliva.tisato@burlo.trieste.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvia Tisato, MD
Organizational Affiliation
Institute for Maternal and Child Health IRCCS Burlo Garofolo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
City
Trieste
ZIP/Postal Code
34137
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvia Tisato, MD
Phone
00390403785111
Email
silvia.tisato@burlo.trieste.it

12. IPD Sharing Statement

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Acupuncture in Emergency Delirium After Tonsillectomy

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