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

NCT06046027 | Completed

• 1 other identifier: FF-2019-413
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  up to 24 hours post surgery

Secondary Outcomes (1)

• Numbers of rescue antiemetic needed

  up to 24 hours post surgery

Other Outcomes (2)

• Complications

  up to 24 hours post surgery

• Parental satisfaction

  up to 24 hours post surgery

Study Arms (2)

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

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.

Device: Accupressure band

Interventions

Accupressure band DEVICE

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

Accupressure Group; Placebo Group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Hospital Canselor Tuanku Muhriz

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (3)

• 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.

  PMID: 26522652 BACKGROUND

• 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.

  PMID: 15851892 BACKGROUND

• 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.

  PMID: 15562045 BACKGROUND

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: January 31, 2020
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)