Acupuncture in Emergency Delirium After Tonsillectomy

January 15, 2024 updated by: IRCCS Burlo Garofolo

Acupuncture Management of Emergence Agitation in Children Undergoing Tonsillectomy: a Randomized Controlled Trial

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.

Study Overview

Status

Status

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Withdrawn

Conditions

Conditions

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Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

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Interventional

Phase

Phase

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  • Not Applicable

Contacts and Locations

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Study Contact

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Study Contact Backup

Study Locations

  • Italy
      • Trieste, Italy, 34137
        • Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

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Ages Eligible for Study

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Procedure: Acupuncture
Application of acupuncture
No Intervention: Standard care group
The patients will follow the standard procedure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative agitation evaluated with the PAED scale
Time Frame: Within 5 minutes from arrival in the post anesthesia care unit
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative agitation evaluated with the PAED scale
Time Frame: 30 minutes after the arrival in the post anesthesia care unit
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.
30 minutes after the arrival in the post anesthesia care unit
Postoperative agitation evaluated with the Watcha Scale
Time Frame: Within 5 minutes from arrival in the post anesthesia care unit
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.
Within 5 minutes from arrival in the post anesthesia care unit
Postoperative agitation evaluated with the Cravero scale
Time Frame: Within 5 minutes from arrival in the post anesthesia care unit
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.
Within 5 minutes from arrival in the post anesthesia care unit
Postoperative agitation evaluated with the Watcha Scale
Time Frame: 30 minutes after the arrival in the post anesthesia care unit
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.
30 minutes after the arrival in the post anesthesia care unit
Postoperative agitation evaluated with the Cravero scale
Time Frame: 30 minutes after the arrival in the post anesthesia care unit
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.
30 minutes after the arrival in the post anesthesia care unit
Pain evaluated with the FLACC scale
Time Frame: Within 5 minutes from arrival in the post anesthesia care unit
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.
Within 5 minutes from arrival in the post anesthesia care unit
Pain evaluated with the FLACC scale
Time Frame: 30 minutes after the arrival in the post anesthesia care unit
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.
30 minutes after the arrival in the post anesthesia care unit
Unintended harm caused by patients agitation
Time Frame: Within 5 minutes from arrival in the post anesthesia care unit
Between groups difference in harming surgical repair, harming self or caregivers, pulling out IV's draws or tubes
Within 5 minutes from arrival in the post anesthesia care unit
Unintended harm caused by patients agitation
Time Frame: 30 minutes after the arrival in the post anesthesia care unit
Between groups difference in harming surgical repair, harming self or caregivers, pulling out IV's draws or tubes
30 minutes after the arrival in the post anesthesia care unit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
IRCCS Burlo Garofolo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Silvia Tisato, MD, Institute for Maternal and Child Health IRCCS Burlo Garofolo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 17, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC 33/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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