Beijing tongren Hospital, Capital Medical University,
Beijing, China
NCT Number: NCT07472764
This study investigates whether auricular acupressure can reduce postoperative emergence agitation among preschool children following adenoidectomy.
Trial opening soon.
Get Notified3 year–6 year
All sexes
Interventional
Not applicable
Beijing, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 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.)
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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):
Contact information is provided by the study sponsor or research team.
Beijing Tongren Hospital
Other
Auricular Acupressure for Reducing Postoperative Emergence Agitation in Preschool Children Undergoing Adenoidectomy: A Prospective, Randomized Controlled Trial
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