Auricular Acupressure for Reducing Postoperative Emergence Agitation in Preschool Children

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-6
SponsorBeijing Tongren Hospital

About this trial

This study investigates whether auricular acupressure can reduce postoperative emergence agitation among preschool children following adenoidectomy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

(1) American Society of Anesthesiologists (ASA) physical status classification of I to III; (2) Children aged 3 to 6 years scheduled for elective adenoidectomy; (3) No damage to the epidermis of the external ear.

Disqualifiers

(1) Children taking anti-anxiety or antidepressant medications; (2) Children with a history of psychiatric disorders or current psychiatric abnormalities; (3) Children with cognitive deficits or cognitive and intellectual developmental disorders; (4) Children with allergies to auricular acupressure beads; (5) Participation in other clinical trials within the past three months.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Auricular acupressure

    Device

    Auricular acupressureis a non-invasive technique derived from traditional Chinese medicine (TCM), where small seeds (typically from Vaccaria segetalis plants) or magnetic beads are attached to specific points on the outer ear using adhesive tape. The location of acupoints was determined in accordance with the World Health Organization (WHO) International Standard Terminologies for Auricular Acupuncture, as specified in WHO Standard Acupuncture Point Locations in the Western Pacific Region (ISBN 978-92-9061-248-7).

  • sham auricular acupressure

    Device

    For children in the sham stimulation group, we followed the same consultation and auricular point localization procedures, but no Vaccaria seed pressure stimulation was applied. Instead, only an adhesive patch of identical appearance was affixed to the skin.

Treatment groups

110 Participants
are divided into 2 treatment groups
Group A: Auricular acupressureExperimental treatment 1 intervention
Group B: Sham Auricular acupressureSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

The incidence of emergence agitation

During the anesthesia emergence period assessments were conducted at 5-minute intervals for 15 minutes, recording the Pediatric Anesthesia Emergence Delirium (PAED) scale.The highest recorded score was used, with a PAED score≥10 defined as the occurrence of emergence delirium.The incidence of emergence agitation was calculated according to the scale scores.

Time frame
The period from the patient's entry into the Post-Anesthesia Care Unit (PACU) until their discharge from the PACU.

Secondary outcomes

1

the score of FLACC (Face, Legs, Activity, Cry, Consolability)

Pain in pediatric patients was assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, and scores were compared between the two groups.Full name of the FLACC Postoperative Pain Rating Scale:Face (Facial Expression) , Legs (Lower Limb Posture), Activity (Activity Level), Cry (Crying), Consolability (Consolability).Each item is scored from 0 to 2 points. Total score range: 0-10 points. Total Score Interpretation Lowest score: 0 points → Indicates no signs of pain. Highest score: 10 points → Indicates severe pain. Score meaning: A higher score indicates more severe pain and a worse outcome. (Note: The FLACC scale assesses pain intensity; high scores require medical intervention for pain relief.)

Time frame
During the patient's entire PACU stay.
2

Preoperative anxiety score of mYPAS (modified Yale Preoperative Anxiety Scale)

Using the modified Yale Preoperative Anxiety Scale (mYPAS) criteria, anxiety levels were assessed at the time of parent-child separation and subsequently compared.Modified Yale Preoperative Anxiety Scale rates a child's behavior in specific preoperative settings through observation. It comprises 5 core domains, include activity, vocalizations, emotional expressivity, state of arousal and Use of Parent, each scored based on observed behaviors. Domain scores are not evenly weighted; the total score is the sum of the actual scores from each domain after conversion. Lowest possible score: Approximately 23.3 points (result of standardizing the sum of the lowest domain scores; raw behavioral scores are converted via formula into a standardized total). Highest possible score: 100 points (standardized maximum). Score meaning: A higher score indicates a greater degree of preoperative anxiety, representing a worse outcome.

Time frame
At the moment before entering the operating room.
3

the score of Induction Compliance Checklist during anesthetic induction

During anesthetic induction patient compliance was assessed using the Induction Compliance Checklist (ICC).This scale is used to assess a child's behavioral compliance during the anesthesia induction phase. It consists of 5 levels, with a single overall score assigned based on the child's behavior ranging from cooperative to completely uncooperative. 0 Points - Excellent Compliance 1. Point - Slight Resistance 2. Points - Moderate Resistance 3. Points - Severe Resistance 4. Points - Total Noncompliance Lowest Score: 0 points → Indicates full cooperation and a smooth induction process Highest Score: 4 points → Indicates total noncooperation and a difficult induction process Score Meaning: A higher score indicates poorer compliance, greater difficulty during anesthesia induction, and a worse clinical outcome.

Time frame
during anesthetic induction
4

The incidence of postoperative complications

The incidence of postoperative complications such as nausea and vomiting, coughing, laryngospasm or bronchospasm, bradycardia , and oxygen desaturation, along with PACU stay duration.

Time frame
PACU stay duration

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: