Trial Review

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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] 298504 0
none
Universal Trial Number (UTN)
U1111-1235-4306
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tonsillectomy 313297 0
Condition category
Condition code
Anaesthesiology 311741 311741 0 0
Pain management
Oral and Gastrointestinal 311809 311809 0 0
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] 314755 0
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] 320428 0
Pain score following tonsillectomy as assessed by the Face, Legs, Activity, Cry, Consolability (FLACC) scale with the intervention of intraoperative acupuncture.


Timepoint [1] 320428 0
in the first 24 postoperative hours in hospital and on day 1,2 5 at home.
Secondary outcome [1] 371561 0
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] 371561 0
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?
No
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] 14003 0
North West Brisbane Private Hospital - Everton Park
Recruitment hospital [2] 14004 0
Holy Spirit Northside - Chermside
Recruitment postcode(s) [1] 26782 0
4053 - Everton Park
Recruitment postcode(s) [2] 26783 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 303049 0
Self funded/Unfunded
Name [1] 303049 0
Dr David Ho
Country [1] 303049 0
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] 303030 0
None
Name [1] 303030 0
Address [1] 303030 0
Country [1] 303030 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303600 0
Greenslopes Research and Ethics Committee
Ethics committee address [1] 303600 0
Ethics committee country [1] 303600 0
Australia
Date submitted for ethics approval [1] 303600 0
07/04/2016
Approval date [1] 303600 0
01/06/2016
Ethics approval number [1] 303600 0
Protocol 16/28

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 94214 0
Dr David Ho
Address 94214 0
Northside Anaesthesia, Level 3, Mary Aitkenhead Building, St Vincents Private Hospital Northside, 627 Rode Rd, Chermside 4032, Queensland, Australia.
Country 94214 0
Australia
Phone 94214 0
+61 733597011
Fax 94214 0
+61 733597022
Email 94214 0
[email protected]
Contact person for public queries
Name 94215 0
David Ho
Address 94215 0
Dr David Ho - Northside Anaesthesia, Level 3, Mary Aitkenhead Building, St Vincents Private Hospital Northside, 627 Rode Rd, Chermside 4032, Queensland, Australia.
Country 94215 0
Australia
Phone 94215 0
+61 733597011
Fax 94215 0
+61 733597022
Email 94215 0
[email protected]
Contact person for scientific queries
Name 94216 0
David Ho
Address 94216 0
Dr David Ho - Northside Anaesthesia, Level 3, Mary Aitkenhead Building, St Vincents Private Hospital Northside, 627 Rode Rd, Chermside 4032, Queensland, Australia.
Country 94216 0
Australia
Phone 94216 0
+61 733597011
Fax 94216 0
+61 733597022
Email 94216 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2360Study protocol    377789-(Uploaded-16-06-2019-13-45-44)-Study-related document.docx
2361Informed consent form    377789-(Uploaded-16-06-2019-13-47-01)-Study-related document.pdf
2362Ethical 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
SourceTitleYear of PublicationDOI
Dimensions AIIntraoperative acupuncture as complementary analgesic for post-tonsillectomy pain in children—a prospective randomised clinical trial of effects and safety2020https://doi.org/10.21037/ajo-19-74
N.B. These documents automatically identified may not have been verified by the study sponsor.