Postoperative Nausea and VomitingNCT06046027
P6 Acupressure Band for Prevention of Postoperative Nausea and Vomiting in Children
A study testing Accupressure band in people with Postoperative Nausea and Vomiting and Postoperative Nausea and Vomiting \(PONV\)Acuppressure, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial summary
Nausea and vomiting after surgery are one of the most common side effects of general anaesthesia. Pressure at P6 acupuncture point around wrist area using acupressure band has been proven to reduce nausea and vomiting in adult. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Postoperative Nausea and Vomiting, Postoperative Nausea and Vomiting \(PONV\)Acuppressure
- What is being tested?
- Accupressure band
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteMalaysia
- Study dates
- 31 Jan 2020to 1 Jul 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 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- General surgery including open and laparoscopic hernia, orchidopexy surgery, orthopaedic and ENT surgery
- Duration of surgery of more than 30 mins and less than 4 hour
- ASA I or II
Who cannot join
- Inflammation over the relevant acupressure point and abnormal upper limb anatomy
- Planned admission to PACU/ICU post-operative or requiring mechanical ventilation post-operative
- Patient on antiemetic prior to surgery
- Known allergy to metoclopramide
- Suspected circulation or vascular problem of upper limb
- Upper limb surgery - strabismus surgery
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Canselor Tuanku Muhriz
Kuala Lumpur, Kuala Lumpur, 56000
About this study
Official title: Efficacy of P6 Acupressure Band For Prevention of Postoperative Nausea and Vomiting In Children: A Randomized Controlled Trial
Nausea and vomiting after surgery are one of the most common side effects of general anaesthesia. Pressure at P6 acupuncture point around wrist area using acupressure band has been proven to reduce nausea and vomiting in adult. We would like to see if this acupressure band can reduce nausea and vomiting in children after surgery.
Prior to operation, we will apply an elastic band at the P6 acupoint on your child's both hands. Your child will undergo anaesthesia as per usual and surgery as planned, with the elastic band onboard. Upon completion of surgery, your child will be required to wear the band and should not be removed. Your child will be monitored for up to 24 hours for episodes of nausea and vomiting. If so, rescue antivomit medication will be given. After 24 hours, we will record your level of satisfaction with the regimen provided
Read the detailed description
Postoperative nausea and vomiting (PONV) are the second most prevalent complaint among paediatric patients and is one of the most complex and serious concerns in anaesthetic practice. In addition to causing the patient misery and discomfort, nausea and vomiting can decrease parental satisfaction, increase the risk of pain and bleeding, increase resource utilisation, and lengthen the stay in the postoperative ward and hospital. In all paediatric populations, the incidence ranges from 13 to 42%, making it twice as prevalent as in adults[1].
The Eberhart categorization system for risk assessment of postoperative vomiting in paediatric patients encompasses several factors, namely age beyond 3 years, surgical length exceeding 30 minutes, undergoing strabismus surgery, and having a personal or family history of postoperative nausea and vomiting (PONV). The occurrence rates of postoperative nausea and vomiting (PONV) are reported as 10%, 20%, 50%, and 70% when one, two, three, or four risk factors are present, respectively [2]. A range of pharmacological and non-pharmacological approaches have been documented for the prevention and treatment of postoperative nausea and vomiting (PONV). Among the several non-pharmacological methods, acupoint stimulation appears to be the most promising approach[1].
The stimulation of acupoints can be classified as invasive and non-invasive techniques. Acupressure, a form of non-invasive acupoint stimulation, has been performed by the Chinese for over 2500 years[3]. It uses magnets, pellets, electrical stimulation, or micro beads to trigger the central nervous system, either locally or from a distance3. It is based on the idea that life energy moves through "meridians" in the body. When physical pressure is put on these meridians, it is meant to clear any blockages. Instead of using needles, acupressure includes putting pressure (usually with fingertips) on certain points on the body[3]. A Cochrane review and meta-analysis of the different ways to stimulate acupoints at the traditional Chinese Pericardium 6 (P6) point to avoid PONV shows that it works better than a placebo in adults[4, 5].
Research conducted on paediatric patients undergoing adenoidectomy or tonsillectomy has examined the efficacy of different acu-stimulation techniques, such as electroacupuncture and a combination of needle acupuncture and acupressure band, in comparison to standard care involving the use of dexamethasone. The findings of these studies indicate a statistically significant decrease in the occurrence of retching or vomiting among children who received acu-stimulation methods, as opposed to those who received standard care.[6, 7] In a systematic review conducted on a sample of 844 children, different approaches to administering acupoint stimulation at P6 were evaluated. The findings of this study revealed a statistically significant decrease in vomiting when compared to the control groups, which included Sham, placebo control, and conventional treatment.[8] This study postulates that the use of acupressure at the P6 acupoint in children, utilising an acupressure band, may provide an additional reduction in the occurrence of postoperative nausea and vomiting when combined with normal care. The objective of this study was to evaluate the efficacy of acupressure bands targeting the P6 acupoint in mitigating post-operative nausea and vomiting (PONV) among paediatric patients and to compare the postoperative need for metoclopramide between the group of patients using P6 acupressure bands and the group using a placebo.
- Being tested
- Accupressure band
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accupressure bandDevice
The accupressure band and wirst band will be place 20 minutes prior to induction of anaesthesia. The induction and maintenance of anaesthesia performed at the discretion of the supervising anaesthesiologist. The maintenance of anaesthesia was achieved by administering sevoflurane at a minimum alveolar concentration (MAC) range of 1 to 1.2. A fresh gas flow rate of 2 L/min comprising a 50:50 concentration mixture of oxygen and air were employed. The patients will be ventilated and maintain end-tidal carbon dioxide (ETCO2) levels within the range of 35-40mmHg. All patients were administered intravenous dexamethasone at a dosage of 0.1mg/kg as a conventional prophylaxis for postoperative nausea and vomiting (PONV) following the induction of anaesthesia. Additionally, intravenous morphine was administered at a dosage of 0.05mg/kg and suppositories containing paracetamol were given at a dosage of 30mg/kg for analgesic purposes. Patients will be extubated at the end of surgery
| Study group | Role | What they receive |
|---|---|---|
| Accupressure Group | Experimental | Patient in Accupressure Group applied an acupressure band (ACU-STRAPTM) on bilateral hands with a plastic bead at P6 acupoint, which is situated at the wrist between the tendons of the palmaris longus and flexor carpi radialis, 2 cun proximal from the distal palmar crease as shown in Figure 1, half an hour prior to surgery at the operation theatre reception Receives: Device: Accupressure band |
| Placebo Group | Placebo comparator | Patients in Placebo Group will receive a standard elastic band without acuppresure bead, which will be applied to the patient's wrist. Receives: Device: Accupressure band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident of nausea and vomiting within 24 hours post operatively
Incident of nausea and vomiting will be recorded in recovery area and hourly until 24H
Measured: up to 24 hours post surgery
Secondary outcomes (1)
Numbers of rescue antiemetic needed
Dosage and frequency of rescue antiemetic prescribed postoperatively will be recorded
Measured: up to 24 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start31 Jan 2020
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046027
- Sponsor's protocol ID
- FF-2019-413
- Status last verified
- Sep 2023
- First submitted
- 13 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared upon request
Publications
Lee A, Chan SK, Fan LT. Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2015 Nov 2;2015(11):CD003281. doi: 10.1002/14651858.CD003281.pub4.
PubMed 26522652Chernyak GV, Sessler DI. Perioperative acupuncture and related techniques. Anesthesiology. 2005 May;102(5):1031-49; quiz 1077-8. doi: 10.1097/00000542-200505000-00024.
PubMed 15851892Eberhart LHJ, Geldner G, Kranke P, Morin AM, Schauffelen A, Treiber H, Wulf H. The development and validation of a risk score to predict the probability of postoperative vomiting in pediatric patients. Anesth Analg. 2004 Dec;99(6):1630-1637. doi: 10.1213/01.ANE.0000135639.57715.6C.
PubMed 15562045
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of P6 Acupressure Band For Prevention of Postoperative Nausea and Vomiting In Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06046027
- Acronym / sponsor ID
- FF-2019-413
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 31 Jan 2020 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 21 Sep 2023 (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.
Nausea and vomiting after surgery are one of the most common side effects of general anaesthesia. Pressure at P6 acupuncture point around wrist area using acupressure band has been proven to reduce nausea and vomiting in adult. We would like to see if this acupressure band can reduce nausea and vomiting in children after surgery.
Prior to operation, we will apply an elastic band at the P6 acupoint on your child's both hands. Your child will undergo anaesthesia as per usual and surgery as planned, with the elastic band onboard. Upon completion of surgery, your child will be required to wear the band and should not be removed. Your child will be monitored for up to 24 hours for episodes of nausea and vomiting. If so, rescue antivomit medication will be given. After 24 hours, we will record your level of satisfaction with the regimen provided
Detailed description
Postoperative nausea and vomiting (PONV) are the second most prevalent complaint among paediatric patients and is one of the most complex and serious concerns in anaesthetic practice. In addition to causing the patient misery and discomfort, nausea and vomiting can decrease parental satisfaction, increase the risk of pain and bleeding, increase resource utilisation, and lengthen the stay in the postoperative ward and hospital. In all paediatric populations, the incidence ranges from 13 to 42%, making it twice as prevalent as in adults[1].
The Eberhart categorization system for risk assessment of postoperative vomiting in paediatric patients encompasses several factors, namely age beyond 3 years, surgical length exceeding 30 minutes, undergoing strabismus surgery, and having a personal or family history of postoperative nausea and vomiting (PONV). The occurrence rates of postoperative nausea and vomiting (PONV) are reported as 10%, 20%, 50%, and 70% when one, two, three, or four risk factors are present, respectively [2]. A range of pharmacological and non-pharmacological approaches have been documented for the prevention and treatment of postoperative nausea and vomiting (PONV). Among the several non-pharmacological methods, acupoint stimulation appears to be the most promising approach[1].
The stimulation of acupoints can be classified as invasive and non-invasive techniques. Acupressure, a form of non-invasive acupoint stimulation, has been performed by the Chinese for over 2500 years[3]. It uses magnets, pellets, electrical stimulation, or micro beads to trigger the central nervous system, either locally or from a distance3. It is based on the idea that life energy moves through "meridians" in the body. When physical pressure is put on these meridians, it is meant to clear any blockages. Instead of using needles, acupressure includes putting pressure (usually with fingertips) on certain points on the body[3]. A Cochrane review and meta-analysis of the different ways to stimulate acupoints at the traditional Chinese Pericardium 6 (P6) point to avoid PONV shows that it works better than a placebo in adults[4, 5].
Research conducted on paediatric patients undergoing adenoidectomy or tonsillectomy has examined the efficacy of different acu-stimulation techniques, such as electroacupuncture and a combination of needle acupuncture and acupressure band, in comparison to standard care involving the use of dexamethasone. The findings of these studies indicate a statistically significant decrease in the occurrence of retching or vomiting among children who received acu-stimulation methods, as opposed to those who received standard care.[6, 7] In a systematic review conducted on a sample of 844 children, different approaches to administering acupoint stimulation at P6 were evaluated. The findings of this study revealed a statistically significant decrease in vomiting when compared to the control groups, which included Sham, placebo control, and conventional treatment.[8] This study postulates that the use of acupressure at the P6 acupoint in children, utilising an acupressure band, may provide an additional reduction in the occurrence of postoperative nausea and vomiting when combined with normal care. The objective of this study was to evaluate the efficacy of acupressure bands targeting the P6 acupoint in mitigating post-operative nausea and vomiting (PONV) among paediatric patients and to compare the postoperative need for metoclopramide between the group of patients using P6 acupressure bands and the group using a placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accupressure Group | Experimental | Device: Accupressure bandPatient in Accupressure Group applied an acupressure band (ACU-STRAPTM) on bilateral hands with a plastic bead at P6 acupoint, which is situated at the wrist between the tendons of the palmaris longus and flexor carpi radialis, 2 cun proximal from the distal palmar crease as shown in Figure 1, half an hour prior to surgery at the operation theatre reception |
| Placebo Group | Placebo comparator | Device: Accupressure bandPatients in Placebo Group will receive a standard elastic band without acuppresure bead, which will be applied to the patient's wrist. |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- General surgery including open and laparoscopic hernia, orchidopexy surgery, orthopaedic and ENT surgery
- Duration of surgery of more than 30 mins and less than 4 hour
- ASA I or II
Key exclusion criteria (6 listed)
- Inflammation over the relevant acupressure point and abnormal upper limb anatomy
- Planned admission to PACU/ICU post-operative or requiring mechanical ventilation post-operative
- Patient on antiemetic prior to surgery
- Known allergy to metoclopramide
- Suspected circulation or vascular problem of upper limb
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 |
|---|---|---|
| Accupressure bandThe accupressure band and wirst band will be place 20 minutes prior to induction of anaesthesia. The induction and maintenance of anaesthesia performed at the discretion of the supervising anaesthesiologist. The maintenance of anaesthesia was achieved by administering sevoflurane at a minimum alveolar concentration (MAC) range of 1 to 1.2. A fresh gas flow rate of 2 L/min comprising a 50:50 concentration mixture of oxygen and air were employed. The patients will be ventilated and maintain end-tidal carbon dioxide (ETCO2) levels within the range of 35-40mmHg. All patients were administered intravenous dexamethasone at a dosage of 0.1mg/kg as a conventional prophylaxis for postoperative nausea and vomiting (PONV) following the induction of anaesthesia. Additionally, intravenous morphine was administered at a dosage of 0.05mg/kg and suppositories containing paracetamol were given at a dosage of 30mg/kg for analgesic purposes. Patients will be extubated at the end of surgery | Device | Accupressure Group, Placebo Group |
Primary outcome
Incident of nausea and vomiting within 24 hours post operatively
Time frame: up to 24 hours post surgery
Incident of nausea and vomiting will be recorded in recovery area and hourly until 24H
1 secondary outcome
Numbers of rescue antiemetic needed
Time frame: up to 24 hours post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 26522652Lee A, Chan SK, Fan LT. Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting. Cochrane Database Syst Rev. 2015 Nov 2;2015(11):CD003281. doi: 10.1002/14651858.CD003281.pub4.
- Background: PubMed 15851892Chernyak GV, Sessler DI. Perioperative acupuncture and related techniques. Anesthesiology. 2005 May;102(5):1031-49; quiz 1077-8. doi: 10.1097/00000542-200505000-00024.
- Background: PubMed 15562045Eberhart LHJ, Geldner G, Kranke P, Morin AM, Schauffelen A, Treiber H, Wulf H. The development and validation of a risk score to predict the probability of postoperative vomiting in pediatric patients. Anesth Analg. 2004 Dec;99(6):1630-1637. doi: 10.1213/01.ANE.0000135639.57715.6C.
- Individual participant dataSharing planned: No. IPD will be shared upon request
Related trials for Postoperative Nausea and Vomiting
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accupressure band in people with Postoperative Nausea and Vomiting and Postoperative Nausea and Vomiting \(PONV\)Acuppressure, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 21 Sep 2023. 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 Malaysia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident of nausea and vomiting within 24 hours post operatively (time frame: up to 24 hours post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06046027, which also lists 3 linked publications.
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 21 Sep 2023.