Effects of Perioperative TEAS on Postoperative Pain and Agitation in Pediatric Adenoidectomy and Tonsillectomy
Effects of Perioperative Transcutaneous Electrical Acupoint Stimulation on Postoperative Pain and Agitation in Pediatric Adenoidectomy and Tonsillectomy
1 other identifier
interventional
200
1 country
1
Brief Summary
Adenoidectomy and tonsillectomy are generally performed during childhood to help reduce snoring and improve sleep or caused by recurrent infection.And insufficient analgesia may result in postoperative sore throat, difficulty swallowing, aspiration, delayed discharge, spasm, and agitation. Remedial analgesic drugs such as morphine and opioids may lead to postoperative respiration depression, desaturation and vomiting.Transcutaneous electrical acupoint stimulation (TEAS) is a peripheral stimulation, which is a modern therapy derived from traditional acupuncture. Relevant clinical trials show that it can effectively relieve pain, and has slight side-effects.However, most of these clinical trials are conducted in adults, and there have been few clinical trials involving children. For this reason, in line with good tolerance and less side effects of TEAS, ,this study is designed to enhance the therapeutic effect of adenoidectomy and tonsillectomy pain by means of taking advantage of the skin-sticking electro-acupuncture.It is also hoped that this study can certify if TEAS can reduce the amount and side effects of analgesic drugs, such as morphine, and improve the postoperative safety of children, and moreover, explore the possible mechanisms by which TEAS relieve pain in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2022
CompletedFirst Posted
Study publicly available on registry
April 15, 2022
CompletedStudy Start
First participant enrolled
April 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2023
CompletedMay 3, 2022
May 1, 2022
6 months
January 16, 2022
May 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
change from pain score within 48 hours after surgery
it is caused by procedure , and assessed with the Face, Legs, Activity, Cry, Consolability （FLACC ）pain scale,a higher score indicates more severe pain
interval 5minutes for the first 30 minutes after extubation, and then for the outstanding 24 hours and 48 hours after surgery
change from agitation score within 48 hours after surgery
postoperative agitation is a reformed state of mindfulness, which starts with a sudden form of anesthesia and progresses through the early repossession age,it is assessed with the Pediatric Anesthesia Emergence Delirium (PAED) scale.It includes five objects (eye contact with the caregiver, purposeful action, and awareness of surroundings, restlessness, and inconsolability). Each item was scored by five scores (0 to 4) permitting to its degree, for a maximum of 20 points.Agitation was defined as a PAED 10 points.
interval 5 minutes for the first 30 minutes after extubation, and then for the outstanding 24 hours and 48 hours after surgery
Secondary Outcomes (15)
duration of anesthesia
Intraoperative (from the start of induction to endotracheal tube (EET) removal)
duration of surgery
Intraoperative (from the insertion of the mouth gag to removal of the mouth gag)
recovery time
Intraoperative (from sevoflurane discontinuation to spontaneous eye opening)
extubation time
Intraoperative (from discontinuation of sevoflurane to tracheal extubation)
PACU length of stay(PACU-LOS)
up to 48 hours (from the time patients' arrival in PACU to the time leaving PACU after surgery)
- +10 more secondary outcomes
Study Arms (4)
S1
EXPERIMENTALTEAS treatment initiated at 30 minutes before induction and lasted for 30min,TEAS treatment(disperse-dense waves; frequency, 2/100 Hz)on acupoints Hegu(LI4) , Neiguan(PC6) and Zusanli（ST 36）of both sides, and the present intensity(8～12 mA) was the maximum current that could be tolerated.Then, the TEAS treatment was administered twice a day (once in the morning and once in the afternoon) on the first and second postoperative day, which lasted for 30 minutes each time.
S2
EXPERIMENTALTEAS treatment initiated immediately after induction and stopped at the end of surgery,TEAS treatment(disperse-dense waves; frequency, 2/100 Hz)on acupoints Hegu(LI4) , Neiguan(PC6) and Zusanli（ST 36）of both sides, and the present intensity(8～12 mA) was the maximum current that could be tolerated.Then, the TEAS treatment was administered twice a day (once in the morning and once in the afternoon) on the first and second postoperative day, which lasted for 30 minutes each time.
S3
EXPERIMENTALTEAS treatment initiated immediately after extubating and lasted for 30 minutes,TEAS treatment(disperse-dense waves; frequency, 2/100 Hz)on acupoints Hegu(LI4) , Neiguan(PC6) and Zusanli（ST 36）of both sides, and the present intensity(8～12 mA) was the maximum current that could be tolerated.Then, the TEAS treatment was administered twice a day (once in the morning and once in the afternoon) on the first and second postoperative day, which lasted for 30 minutes each time.
control
SHAM COMPARATORthe control group was given all manipulations without electrical stimulation, electrodes were placed on the same acupoints, but no current was given
Interventions
transcutaneous electrical acupoint stimulation (TEAS), the modern therapies derived from traditional acupuncture, which could activate nerve endings or fibers and generate action potentials.s. TEAS uses self-adhesive electrodes placed on the surface of acupoints, instead of needles for electrical stimulation.The resulting stimulation signals, which are transmitted to the spinal cord and brain, stimulate the central nervous system to generate specific chemical mediators to induce relevant physiological effects.
Eligibility Criteria
You may qualify if:
- the American Society of Anesthesiologists physical status Ⅰ and Ⅱ.
- Ranging in age from 4 to 10.
- Suffering from adenoid and/or tonsil hypertrophy
- Preparing for elective surgery under general anesthesia with a signed written informed consent by parents..
You may not qualify if:
- immunological, neurological, and hematological disorders
- having any drug allergy or asthma, as well as allergic constitution
- with congenital heart disease or various malignant arrhythmias
- skin infections existing at acupoints and their surroundings
- history of receiving acupuncture or electroacupuncture treatment
- long-term use of analgesic or sedative drugs
- used to having unilateral tonsil ablation
- refusing to join the trial investigator
- postoperative trachea spasm or laryngeal edema occurring
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xi'an Children's Hospital
Xi'an, Shaanxi, 710000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Fang Li Yang
Xi 'an children's hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2022
First Posted
April 15, 2022
Study Start
April 25, 2022
Primary Completion
October 30, 2022
Study Completion
March 10, 2023
Last Updated
May 3, 2022
Record last verified: 2022-05