Emergence Agitation
Conditions
Keywords
Auricular Acupressure, Emergence agitation, Postoperative pain, non-invasive Traditional Chinese Medicine, Pediatric Anesthesia
Brief summary
This study investigates whether auricular acupressure can reduce postoperative emergence agitation among preschool children following adenoidectomy.
Detailed description
Emergence agitation is a frequent complication after pediatric head and neck surgery. Despite this, evidence for non-pharmacological preventive strategies is limited. This study explores the efficacy of auricular acupressure, a non-invasive Traditional Chinese Medicine technique, in preventing postoperative agitation among these children.
Interventions
DEVICEAuricular acupressure
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).
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.
Sponsors
Beijing Tongren Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* (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.
Exclusion criteria
* (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of emergence agitation | The period from the patient's entry into the Post-Anesthesia Care Unit (PACU) until their discharge from the PACU. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the score of FLACC (Face, Legs, Activity, Cry, Consolability) | During the patient's entire PACU stay. | 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.) |
| Preoperative anxiety score of mYPAS （modified Yale Preoperative Anxiety Scale) | At the moment before entering the operating room. | 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. |
| the score of Induction Compliance Checklist during anesthetic induction | 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. |
| The incidence of postoperative complications | PACU stay duration | The incidence of postoperative complications such as nausea and vomiting, coughing, laryngospasm or bronchospasm, bradycardia , and oxygen desaturation, along with PACU stay duration. |
| the score of Post-Hospitalization Behavior Questionnaire (PHBQ) | At 1 month and 3 months postoperatively | Follow-ups were conducted with the children's guardians at 1 month and 3 months postoperatively using the Post-Hospitalization Behavior Questionnaire (PHBQ), and the scores were compared between the two groups. Scoring Criteria (Per Item): 1. point: No change in behavior 2. points: Mild worsening of behavior 3. points: Significant worsening of behavior 4. points: Extreme worsening of behavior 5. points: Marked as "Not Applicable" Core Behavioral Dimensions and Example Items 1. General Anxiety/Withdrawal 2. Separation Anxiety 3. Sleep Disturbance 4. Eating Pattern Change 5. Aggression/Antagonism 6. Regression Lowest Possible Score: 27 points (all items rated "no change") Highest Possible Score: 108 points (all items rated "extreme worsening," with no "not applicable" items) Score Meaning: A higher score indicates more severe postoperative behavioral problems and a worse outcome. |
Countries
China
Contacts
CONTACTjinhan fan
STUDY_DIRECTORGuyan Wang
Beijing Tongren Hospital
Outcome results
None listed