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Trial registered on ANZCTR

Registration number

ACTRN12619000922178

Ethics application status

Approved

Date submitted

16/06/2019

Date registered

2/07/2019

Date last updated

16/07/2019

Date data sharing statement initially provided

2/07/2019

Date results provided

2/07/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Acupuncture for complementary pain relief following tonsillectomy in children

Scientific title

Intraoperative acupuncture as complementary analgesic for post-tonsillectomy pain in children – a prospective randomised clinical trial of effects and safety.

Secondary ID [1]

none

Universal Trial Number (UTN)

U1111-1235-4306

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

tonsillectomy

Condition category

Condition code

Anaesthesiology

Pain management

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention:Intraoperative acupuncture during tonsillectomy procedure
Why: To reduce pain postoperatively
How:With approval from the Hospital Ethics Committees, we enrolled 251 children who were undergoing tonsillectomy into our studyAll parents of respective patients received written informed consent prior to surgery. All parents were interviewed and consented by the anaesthetist the night before or on the day of surgery. They were all be given a chance to ask questions at the interview and any further queries were addressed prior to the procedure. In the control group, each child was accompanied by their parent into the operating room for induction of general anaesthesia and followed by the standard procedure of tonsillectomy. In the acupuncture group an identical procedure to that described above was followed, with the addition of the insertion of ten (10) acupuncture needles immediately following induction of anaesthesia and prior to surgical stimulation.
What: Stainless steel acupuncture needles, 15 mm in length and 0.18 mm in diameter (Serin Co, Shizuoka, Japan), were used for the acupuncture. The positions for the needles inserted, according to Chinese Medicine standards, are: LI4 bilaterally, LI20/Bitong bilaterally, CV(REN)22, GV(DU)20, LU1, PC6, ST44, SP6.
Who:All needle acupunctures were performed by Dr David Ho, an anaesthetist and a qualified acupuncturist with certification from the Australian College of Medical Acupuncturist (AMAC).
Where: all procedures were performed in operating rooms at Northwest Private Hospital and St Vincents Northside Hospital.
When/How much: All acupuncture is done only once.The needles were left in situ for the duration of surgery, and immediately removed at the completion of surgery prior to the patient being transferred to recovery room.

Intervention code [1]

Treatment: Other

Comparator / control treatment

In the control group, each child was accompanied by their parent into the operating room for induction of general anaesthesia and followed by the standard procedure of tonsillectomy. No further intervention given.

Control group

Active

Outcomes

Primary outcome [1]

Pain score following tonsillectomy as assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) scale with the intervention of intraoperative acupuncture.

Timepoint [1]

in the first 24 postoperative hours in hospital and on day 1,2 5 at home.

Secondary outcome [1]

Oxycodone requirement following tonsillectomy as assessed by the number of doses given by nurses in hospital and by parents at home with the intervention of intraoperative acupuncture.

Timepoint [1]

in the first 24 postoperative hours in hospital and on postoperative days 1,2 and 5 at home.

Eligibility

Key inclusion criteria

Healthy children undergoing tonsillectomy

Minimum age

2 Years

Maximum age

10 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria included any significant allergy, known bleeding tendency, known or likely airway difficulty and children who had received acupuncture, analgesics or sedatives within 36 hours prior to surgery.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

To minimise allocation bias, this randomisation programme was held by an independent collaborator. On the day of surgery, the anaesthetist would contact the independent collaborator with the names of the patients. The independent collaborator would then assign the patients to the respective groups and inform the anaesthetist just prior to the procedure as to which group the patients had been assigned.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The patients were randomised in blocks of 50 and assigned by a computer-generated programme to either the control or the acupuncture group. To minimise allocation bias, this randomisation programme was held by an independent collaborator.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

All our statistical analyses were performed by an independent statistician. Differences in demographic data were analysed using t-tests for continuous variables and chi-squared tests for categorical variables. Outcome data were analysed using simple linear regression for continuous variables and logistic regression for categorical variables. Data analysis was conducted using Stata v14.2 (StataCorp, College Station, TX, USA).

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

13/06/2016

Date of last participant enrolment

Anticipated

Actual

29/08/2018

Date of last data collection

Anticipated

Actual

5/09/2018

Sample size

Target

258

Accrual to date

Final

251

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

North West Brisbane Private Hospital - Everton Park

Recruitment hospital [2]

Holy Spirit Northside - Chermside

Recruitment postcode(s) [1]

4053 - Everton Park

Recruitment postcode(s) [2]

4032 - Chermside

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Dr David Ho

Address [1]

Dr David Ho - Northside Anaesthesia, Level 3, Mary Aitkenhead Building, St Vincents Private Hospital Northside, 627 Rode Rd, Chermside 4032, Queensland, Australia.

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr David Ho

Address

Dr David Ho - Northside Anaesthesia, Level 3, Mary Aitkenhead Building, St Vincents Private Hospital Northside, 627 Rode Rd, Chermside 4032, Queensland, Australia.

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Greenslopes Research and Ethics Committee

Ethics committee address [1]

Greenslopes Private Hospital
Medical Services
Address:
Newdegate St, Greenslopes QLD 4120

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/04/2016

Approval date [1]

01/06/2016

Ethics approval number [1]

Protocol 16/28

Summary

Brief summary

Summary
Aim:  To investigate the effect of intraoperative acupuncture on postoperative pain in children following tonsillectomy. 
Background: Tonsillectomy in children is usually accompanied by significant morbidity, including postoperative bleeding, pain, nausea, vomiting, poor oral intake and dehydration. Recent evidences in literature indicate that acupuncture may have a role in reducing postoperative pain in these children.
Methods: This prospective randomized controlled trial is to evaluate the effectiveness of intraoperative acupuncture in reducing pain following tonsillectomy in 251 children. All patients received a standardised anaesthesia and surgery including intraoperative Morphine, Dexamethasone, Granisetron and Clonidine. In the acupuncture group, acupuncture was applied at 10 specified points immediately after induction of anaesthesia. Postoperative pain relief consisted of regular Paracetamol and Oxycodone as required. All patients, nursing staffs and parents are blinded. All assessors evaluated postoperative pain using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale. Pain scores were recorded at regular intervals during the first 24 hours in hospital and on day 1,2 and 5 following discharge at home.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr David Ho

Address

Northside Anaesthesia, Level 3, Mary Aitkenhead Building, St Vincents Private Hospital Northside, 627 Rode Rd, Chermside 4032, Queensland, Australia.

Country

Australia

Phone

+61 733597011

Fax

+61 733597022

david@hohoho.net.au

Contact person for public queries

Name

David Ho

Address

Dr David Ho - Northside Anaesthesia, Level 3, Mary Aitkenhead Building, St Vincents Private Hospital Northside, 627 Rode Rd, Chermside 4032, Queensland, Australia.

Country

Australia

Phone

+61 733597011

Fax

+61 733597022

david@hohoho.net.au

Contact person for scientific queries

Name

David Ho

Address

Dr David Ho - Northside Anaesthesia, Level 3, Mary Aitkenhead Building, St Vincents Private Hospital Northside, 627 Rode Rd, Chermside 4032, Queensland, Australia.

Country

Australia

Phone

+61 733597011

Fax

+61 733597022

david@hohoho.net.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Attachment
2360	Study protocol	377789-(Uploaded-16-06-2019-13-45-44)-Study-related document.docx
2361	Informed consent form	377789-(Uploaded-16-06-2019-13-47-01)-Study-related document.pdf
2362	Ethical approval	377789-(Uploaded-16-06-2019-13-47-26)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Intraoperative acupuncture as complementary analgesic for post-tonsillectomy pain in children—a prospective randomised clinical trial of effects and safety	2020	https://doi.org/10.21037/ajo-19-74

N.B. These documents automatically identified may not have been verified by the study sponsor.

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