Emergence DeliriumNCT04693390
Acupuncture in Emergency Delirium After Tonsillectomy
A study testing Acupuncture in people with Emergence Delirium, run by IRCCS Burlo Garofolo at 1 site in Italy.
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". Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2021to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children scheduled to undergo tonsillectomy with or without adenoidectomy
- American Society of Anesthesiologist (ASA) physical status I or II
Who cannot join
- Coagulation disorders (pro-hemorrhagic status)
- Neurological disorders (development delay)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Institute for Maternal and Child Health - IRCCS "Burlo Garofolo"
Trieste, 34137
About this study
Official title: 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.
Read more
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
- Being tested
- Acupuncture
- Keywords
- Acupuncture, Emergency Delirium, Tonsillectomy
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Application of acupuncture
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Acupuncture |
| Standard care group | No intervention | The patients will follow the standard procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 5 minutes from arrival in the post anesthesia care unit
Secondary outcomes (9)
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.
Measured: 30 minutes after the arrival in the post anesthesia care unit
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.
Measured: Within 5 minutes from arrival in the post anesthesia care unit
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.
Measured: Within 5 minutes from arrival in the post anesthesia care unit
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.
Measured: 30 minutes after the arrival in the post anesthesia care unit
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.
Measured: 30 minutes after the arrival in the post anesthesia care unit
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.
Measured: Within 5 minutes from arrival in the post anesthesia care unit
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.
Measured: 30 minutes after the arrival in the post anesthesia care unit
Unintended harm caused by patients agitation
Between groups difference in harming surgical repair, harming self or caregivers, pulling out IV's draws or tubes
Measured: Within 5 minutes from arrival in the post anesthesia care unit
Unintended harm caused by patients agitation
Between groups difference in harming surgical repair, harming self or caregivers, pulling out IV's draws or tubes
Measured: 30 minutes after the arrival in the post anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start15 Jan 2021
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Why it stopped: Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergence DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia Tisato, MD, Principal investigator, Institute for Maternal and Child Health IRCCS Burlo Garofolo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693390
- Sponsor's protocol ID
- RC 33/2020
- Status last verified
- Jan 2024
- First submitted
- 30 Dec 2020
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture Management of Emergence Agitation in Children Undergoing Tonsillectomy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04693390
- Acronym / sponsor ID
- RC 33/2020
- Conditions
- Emergence Delirium
- Keywords
- Acupuncture, Emergency Delirium, Tonsillectomy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: AcupunctureThe acupuncture will be applied at points LI4, ST36, HT7, in association with auriculotherapy point Master Cerebral, immediately after induction of anesthesia for 20 minutes |
| Standard care group | No intervention | –The patients will follow the standard procedure |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children scheduled to undergo tonsillectomy with or without adenoidectomy
- American Society of Anesthesiologist (ASA) physical status I or II
Key exclusion criteria (2 listed)
- Coagulation disorders (pro-hemorrhagic status)
- Neurological disorders (development delay)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureApplication of acupuncture | Procedure or surgery | Acupuncture |
Primary outcome
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.
9 secondary outcomes
Postoperative agitation evaluated with the PAED scale
Time frame: 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
Postoperative agitation evaluated with the Cravero scale
Time frame: 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
Postoperative agitation evaluated with the Cravero scale
Time frame: 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
Pain evaluated with the FLACC scale
Time frame: 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
Unintended harm caused by patients agitation
Time frame: 30 minutes after the arrival in the post anesthesia care unit
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Tisato, MD principal investigator
Institute for Maternal and Child Health IRCCS Burlo Garofolo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Emergence Delirium, run by IRCCS Burlo Garofolo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative agitation evaluated with the PAED scale (time frame: Within 5 minutes from arrival in the post anesthesia care unit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.