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P6 Acupressure Band for Prevention of Postoperative Nausea and Vomiting in Children

Primary Purpose

Postoperative Nausea and Vomiting, Postoperative Nausea and Vomiting \(PONV\)Acuppressure

Status
Completed
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Accupressure band
Sponsored by
Universiti Kebangsaan Malaysia Medical Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Hospital Canselor Tuanku Muhriz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Accupressure Group

Placebo Group

Arm Description

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

Patients in Placebo Group will receive a standard elastic band without acuppresure bead, which will be applied to the patient's wrist.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Numbers of rescue antiemetic needed
Dosage and frequency of rescue antiemetic prescribed postoperatively will be recorded

Full Information

First Posted
September 13, 2023
Last Updated
September 13, 2023
Sponsor
Universiti Kebangsaan Malaysia Medical Centre
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1. Study Identification

Unique Protocol Identification Number
NCT06046027
Brief Title
P6 Acupressure Band for Prevention of Postoperative Nausea and Vomiting in Children
Official Title
Efficacy of P6 Acupressure Band For Prevention of Postoperative Nausea and Vomiting In Children: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 31, 2020 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universiti Kebangsaan Malaysia Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting, Postoperative Nausea and Vomiting \(PONV\)Acuppressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Accupressure Group
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm Description
Patients in Placebo Group will receive a standard elastic band without acuppresure bead, which will be applied to the patient's wrist.
Intervention Type
Device
Intervention Name(s)
Accupressure band
Intervention Description
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
Primary Outcome Measure Information:
Title
Incident of nausea and vomiting within 24 hours post operatively
Description
Incident of nausea and vomiting will be recorded in recovery area and hourly until 24H
Time Frame
up to 24 hours post surgery
Secondary Outcome Measure Information:
Title
Numbers of rescue antiemetic needed
Description
Dosage and frequency of rescue antiemetic prescribed postoperatively will be recorded
Time Frame
up to 24 hours post surgery
Other Pre-specified Outcome Measures:
Title
Complications
Description
Incident of complications related to accupressure band such as pain and redness
Time Frame
up to 24 hours post surgery
Title
Parental satisfaction
Description
Degree of parental satisfaction by likert scale, 1 of very unsatisfied, 3 neutral and 5 very satisfied
Time Frame
up to 24 hours post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Hospital Canselor Tuanku Muhriz
City
Kuala Lumpur
State/Province
Wilayah Persekutuan Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be shared upon request
Citations:
PubMed Identifier
26522652
Citation
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.
Results Reference
background
PubMed Identifier
15851892
Citation
Chernyak GV, Sessler DI. Perioperative acupuncture and related techniques. Anesthesiology. 2005 May;102(5):1031-49; quiz 1077-8. doi: 10.1097/00000542-200505000-00024.
Results Reference
background
PubMed Identifier
15562045
Citation
Eberhart 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.
Results Reference
background

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P6 Acupressure Band for Prevention of Postoperative Nausea and Vomiting in Children

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