the Effect of TEAS on the Children' Pain and AgitationNCT05330494
Effects of Perioperative TEAS on Postoperative Pain and Agitation in Pediatric Adenoidectomy and Tonsillectomy
A study testing transcutaneous electrical acupoint stimulation(TEAS) in people with the Effect of TEAS on the Children' Pain and Agitation, run by Xian Children's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- the Effect of TEAS on the Children' Pain and Agitation
- What is being tested?
- transcutaneous electrical acupoint stimulation(TEAS)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2022to 10 Mar 2023
- 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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..
Who cannot join
- 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
Show all 9Show fewer
- used to having unilateral tonsil ablation
- refusing to join the trial investigator
- postoperative trachea spasm or laryngeal edema occurring
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xi'an Children's Hospital
Xi'an, Shaanxi, 710000
fang Li Yang, doctor, +8613572190398, yanglf@fmmu.edu.cn
peggy Jiang, master, +8618681815265, 562645788@qq.com
About this study
Official title: Effects of Perioperative Transcutaneous Electrical Acupoint Stimulation on Postoperative Pain and Agitation in Pediatric Adenoidectomy and Tonsillectomy
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.
Read the detailed description
Sample size The sample size estimation was based on the incidence of agitation in previous studies. It was selected for a type I error of 0.05, a power of 0.80, and the dropout rate 0f 0.2. The calculation was done through a website program (https://www.medsci.cn), and 200 patients should be included .
Randomization and blinding On arrival at the operating room, a simple randomization method will be used to make sure that the patient is randomly allocated to one of four groups at the 1:1:1:1 ratio.Investigator put the group information in four different envelopes. When the first envelope is extracted, the following patients intelligently extract the group from the remaining envelopes, and so on, until all four envelopes are extracted, and investigator repeat the process. The anesthesiologist who carried out the TEAS procedures and in charge of intraoperative anesthesia is aware of the assignment to group TEAS. But the outcome assessors responsible for collecting and analyzing the data are blind to patient treatment.
Procedure Before entering the operating room, intravenous (IV) access should be clear and no medication is given previously. After entering the operating room, electrocardiogram (ECG), pulse oxygen inundation (SpO2), noninvasive blood pressure (NIBP), SedLine and analgesia nociception index(ANI) are checked according to the manufacturer's recommendations . At the same time, the electrodes are placed at Hegu (LI4), Neiguan (PC 6)and Zusanli (ST36) of both sides.Anesthesia is induced with 2-3 mg/kg of propofol, 0.3 µg/kg of sufentanil. Meanwhile, 0.1 mg/kg of atropine and 0.2 mg/kg of dexamethasone are given to prevent postoperative nausea and oral secretions. After confirming the absence of a response to eye stimulus, 0.15 mg/kg of cis-atracurium is administered. Ventilation is conducted with a mask using 100% oxygen, and tracheal intubation is done after realizing the adequate depth of anesthesia. Next, to preserve the spectral edge frequency (SEF) between 14 and 20, anesthesia is maintained with the end-tidal concentration of sevoflurane 2-2.5 vol% and remifentanil at a dose of 0.2-0.3ug/kg/min during surgery, while ventilation is measured to sustain the end-tidal carbon dioxide (EtCO2) between 40 ± 5 mmHg. Furthermore, baseline hemodynamic variations are kept within a ±20% range.
Intervention patients are randomly divided into TEAS and control groups, and TEAS group is divided into three subgroups (S1, S2 and S3) according to the time of treatment started: S1 treatment initiate at 30 minutes before induction and last for 30min, S2 treatment initiate immediately after induction and stop at the end of surgery, S3 treatment initiate immediately after extubating and last for 30 minutes. The TEAS group receive 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) is the maximum current that could be tolerated. Then, the TEAS treatment is administered twice a day (once in the morning and once in the afternoon) on the first and second postoperative day, which last for 30 minutes each time. And the control group is given all manipulations without electrical stimulation.
Statistical analyses Measurement data of normal distribution are reported as the mean ± SD. Categorical variables are analyzed through chi-squared test or the Fisher's exact probability test and presented as numbers (%). Comparisons between two groups are performed with Student's t-test. Repeated measurements were compared using repeated measure' ANOVA. For all tests, P<0.05 is considered statistically significant.
- Being tested
- transcutaneous electrical acupoint stimulation(TEAS)
- Keywords
- Transcutaneous acupoint electrical stimulation, adenoidectomy, tonsillectomy, pain, agitation
- Medical subject headings
- Psychomotor Agitation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical acupoint stimulation(TEAS)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| S1 | Experimental | TEAS 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. Receives: Other: transcutaneous electrical acupoint stimulation(TEAS) |
| S2 | Experimental | TEAS 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. Receives: Other: transcutaneous electrical acupoint stimulation(TEAS) |
| S3 | Experimental | TEAS 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. Receives: Other: transcutaneous electrical acupoint stimulation(TEAS) |
| control | Sham comparator | the control group was given all manipulations without electrical stimulation, electrodes were placed on the same acupoints, but no current was given Receives: Other: transcutaneous electrical acupoint stimulation(TEAS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
the time required for anesthesia from induction to completion
Measured: Intraoperative (from the start of induction to endotracheal tube (EET) removal)
duration of surgery
the time required for an operation from start to finish
Measured: Intraoperative (from the insertion of the mouth gag to removal of the mouth gag)
recovery time
the time it takes to wake up from sevoflurane discontinuation
Measured: Intraoperative (from sevoflurane discontinuation to spontaneous eye opening)
extubation time
the time from discontinuation of sevoflurane to tracheal extubation, and endotracheal tube was uninvolved when breathing was steady and adequate in rate and depth
Measured: Intraoperative (from discontinuation of sevoflurane to tracheal extubation)
PACU length of stay(PACU-LOS)
patient's stay time in PACU
Measured: up to 48 hours (from the time patients' arrival in PACU to the time leaving PACU after surgery)
postoperative length of stay(PLOS)
The time between the date of operation and discharge in the hospital
Measured: from the date of operation to the date of discharge , an average of 3 days
the concentration of serum interleukin-6 (IL-6), cortisol (COR) and β-endorphin(β-EP)
blood samples were extracted to detect the concentration of serum interleukin-6 (IL-6), cortisol (COR) and β-endorphin(β-EP) at the time of entering the operating room, 30minutes after extubation, 24hours after surgery
Measured: entering the operating room, 30minutes after extubation, 24 hours after surgery
change from mean arterial pressure (MAP) on the day of surgery
refers to the noninvasive mean arterial pressure,the average of arterial blood pressure over a cardiac cycle
Measured: Intraoperative (entering the operating room, just before induction, intubation, insertion of the mouth gag, removal of the mouth gag, 0 minute, 5 minutes, 10 minutes, 15 minutes, 30 minutes after extubation)
change from heart rate (HR) on the day of surgery
number of heart beats per minute
Measured: entering the operating room, just before induction, intubation, insertion of the mouth gag, removal of the mouth gag, 0 minute, 5 minutes, 10 minutes, 15 minutes, 30 minutes after extubation
change from analgesia nociception index(ANI) on the day of surgery
derived from heart rate variability,it is a proposed guide to obtain an adequate control of the analgesic component during anaesthesia,the higher the pain index, the worse the pain relief
Measured: entering the operating room, just before induction, intubation, insertion of the mouth gag, removal of the mouth gag, 0 minute, 5 minutes, 10 minutes, 15 minutes, 30 minutes after extubation
the consumption of remifentanil
remifentanil dosage during the procedure
Measured: Intraoperative (From the beginning to the end of the operation)
postoperative sufentanil rescue rate in PACU
sufentanil was given at a dose of 0.1ug/kg when the patient's pain score was greater than or equal to 4 in PACU
Measured: up to 48 hours (from the time patients' arrival in PACU to the time leaving PACU after surgery)
the incidence of postoperative nausea and vomiting(PONV)
The incidence of postoperative nausea and vomiting in four groups
Measured: from the end of surgery to 48 hours after surgery
postoperative sleep quality
Postoperative sleep status of patients,it is assessed with the Pittsburgh Sleep Quality Index (PSQI) questionnaire,0~5 good sleep quality,6~10 sleep quality is ok,11 to 15 average sleep quality,16 to 21 poor sleep quality
Measured: 24hours and 48 hours after surgery
complications
various adverse events occurred after operation
Measured: from end of surgery to 48 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start25 Apr 2022
- Primary completion30 Oct 2022 (estimated)
- Study completion10 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Effect of TEAS on the Children' Pain and AgitationStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xian Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fang Li Yang, Study chair, Xi 'an children's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330494
- Sponsor's protocol ID
- 2021-016-01
- Status last verified
- May 2022
- First submitted
- 16 Jan 2022
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Perioperative Transcutaneous Electrical Acupoint Stimulation on Postoperative Pain and Agitation in Pediatric Adenoidectomy and Tonsillectomy
- ClinicalTrials.gov ID
- NCT05330494
- Acronym / sponsor ID
- 2021-016-01
- Keywords
- Transcutaneous acupoint electrical stimulation, adenoidectomy, tonsillectomy, pain, agitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xian Children's HospitalOther government
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 30 Oct 2022 (estimated)
- Study completion
- 10 Mar 2023 (estimated)
- First posted
- 15 Apr 2022 (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.
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.
Detailed description
Sample size The sample size estimation was based on the incidence of agitation in previous studies. It was selected for a type I error of 0.05, a power of 0.80, and the dropout rate 0f 0.2. The calculation was done through a website program (https://www.medsci.cn), and 200 patients should be included .
Randomization and blinding On arrival at the operating room, a simple randomization method will be used to make sure that the patient is randomly allocated to one of four groups at the 1:1:1:1 ratio.Investigator put the group information in four different envelopes. When the first envelope is extracted, the following patients intelligently extract the group from the remaining envelopes, and so on, until all four envelopes are extracted, and investigator repeat the process. The anesthesiologist who carried out the TEAS procedures and in charge of intraoperative anesthesia is aware of the assignment to group TEAS. But the outcome assessors responsible for collecting and analyzing the data are blind to patient treatment.
Procedure Before entering the operating room, intravenous (IV) access should be clear and no medication is given previously. After entering the operating room, electrocardiogram (ECG), pulse oxygen inundation (SpO2), noninvasive blood pressure (NIBP), SedLine and analgesia nociception index(ANI) are checked according to the manufacturer's recommendations . At the same time, the electrodes are placed at Hegu (LI4), Neiguan (PC 6)and Zusanli (ST36) of both sides.Anesthesia is induced with 2-3 mg/kg of propofol, 0.3 µg/kg of sufentanil. Meanwhile, 0.1 mg/kg of atropine and 0.2 mg/kg of dexamethasone are given to prevent postoperative nausea and oral secretions. After confirming the absence of a response to eye stimulus, 0.15 mg/kg of cis-atracurium is administered. Ventilation is conducted with a mask using 100% oxygen, and tracheal intubation is done after realizing the adequate depth of anesthesia. Next, to preserve the spectral edge frequency (SEF) between 14 and 20, anesthesia is maintained with the end-tidal concentration of sevoflurane 2-2.5 vol% and remifentanil at a dose of 0.2-0.3ug/kg/min during surgery, while ventilation is measured to sustain the end-tidal carbon dioxide (EtCO2) between 40 ± 5 mmHg. Furthermore, baseline hemodynamic variations are kept within a ±20% range.
Intervention patients are randomly divided into TEAS and control groups, and TEAS group is divided into three subgroups (S1, S2 and S3) according to the time of treatment started: S1 treatment initiate at 30 minutes before induction and last for 30min, S2 treatment initiate immediately after induction and stop at the end of surgery, S3 treatment initiate immediately after extubating and last for 30 minutes. The TEAS group receive 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) is the maximum current that could be tolerated. Then, the TEAS treatment is administered twice a day (once in the morning and once in the afternoon) on the first and second postoperative day, which last for 30 minutes each time. And the control group is given all manipulations without electrical stimulation.
Statistical analyses Measurement data of normal distribution are reported as the mean ± SD. Categorical variables are analyzed through chi-squared test or the Fisher's exact probability test and presented as numbers (%). Comparisons between two groups are performed with Student's t-test. Repeated measurements were compared using repeated measure' ANOVA. For all tests, P<0.05 is considered statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| S1 | Experimental | Other: transcutaneous electrical acupoint stimulation(TEAS)TEAS 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 | Experimental | Other: transcutaneous electrical acupoint stimulation(TEAS)TEAS 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 | Experimental | Other: transcutaneous electrical acupoint stimulation(TEAS)TEAS 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 comparator | Other: transcutaneous electrical acupoint stimulation(TEAS)the control group was given all manipulations without electrical stimulation, electrodes were placed on the same acupoints, but no current was given |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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..
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| transcutaneous electrical acupoint stimulation(TEAS)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. | Other | S1, S2, S3, control |
Primary outcome
change from pain score within 48 hours after surgery
Time frame: interval 5minutes for the first 30 minutes after extubation, and then for the outstanding 24 hours and 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
change from agitation score within 48 hours after surgery
Time frame: interval 5 minutes for the first 30 minutes after extubation, and then for the outstanding 24 hours and 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.
15 secondary outcomes
duration of anesthesia
Time frame: Intraoperative (from the start of induction to endotracheal tube (EET) removal)
duration of surgery
Time frame: Intraoperative (from the insertion of the mouth gag to removal of the mouth gag)
recovery time
Time frame: Intraoperative (from sevoflurane discontinuation to spontaneous eye opening)
extubation time
Time frame: Intraoperative (from discontinuation of sevoflurane to tracheal extubation)
PACU length of stay(PACU-LOS)
Time frame: up to 48 hours (from the time patients' arrival in PACU to the time leaving PACU after surgery)
postoperative length of stay(PLOS)
Time frame: from the date of operation to the date of discharge , an average of 3 days
the concentration of serum interleukin-6 (IL-6), cortisol (COR) and β-endorphin(β-EP)
Time frame: entering the operating room, 30minutes after extubation, 24 hours after surgery
change from mean arterial pressure (MAP) on the day of surgery
Time frame: Intraoperative (entering the operating room, just before induction, intubation, insertion of the mouth gag, removal of the mouth gag, 0 minute, 5 minutes, 10 minutes, 15 minutes, 30 minutes after extubation)
change from heart rate (HR) on the day of surgery
Time frame: entering the operating room, just before induction, intubation, insertion of the mouth gag, removal of the mouth gag, 0 minute, 5 minutes, 10 minutes, 15 minutes, 30 minutes after extubation
change from analgesia nociception index(ANI) on the day of surgery
Time frame: entering the operating room, just before induction, intubation, insertion of the mouth gag, removal of the mouth gag, 0 minute, 5 minutes, 10 minutes, 15 minutes, 30 minutes after extubation
the consumption of remifentanil
Time frame: Intraoperative (From the beginning to the end of the operation)
postoperative sufentanil rescue rate in PACU
Time frame: up to 48 hours (from the time patients' arrival in PACU to the time leaving PACU after surgery)
the incidence of postoperative nausea and vomiting(PONV)
Time frame: from the end of surgery to 48 hours after surgery
postoperative sleep quality
Time frame: 24hours and 48 hours after surgery
complications
Time frame: from end of surgery to 48 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
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.
Fang Li Yang study chair
Xi 'an children's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical acupoint stimulation(TEAS) in people with the Effect of TEAS on the Children' Pain and Agitation, run by Xian Children's Hospital at 1 site in China.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 May 2022. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Hi Wu (+8618092695276, 1922703776@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change from pain score within 48 hours after surgery (time frame: interval 5minutes for the first 30 minutes after extubation, and then for the outstanding 24 hours and 48 hours after surgery). The study lists 2 primary outcomes in all. 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 3 May 2022.