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Acupuncture for complementary pain relief following tonsillectomy in adults

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000287831
Enrollment
221
Registered
2021-03-16
Start date
2017-01-23
Completion date
2020-06-30
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Summary Aim: To investigate the effect of intraoperative acupuncture on postoperative pain in adults following tonsillectomy. Background: Tonsillectomy 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 adults and children. Methods: This prospective randomized controlled trial is to evaluate the effectiveness of intraoperative acupuncture in reducing pain following tonsillectomy in 260 adults. All patients receive a standardised anaesthesia and surgery including intraoperative Oxycodone, Dexamethasone, Granisetron and Paracetamol. Preoperatively, all patients receive ten (10) auricular acupuncture pads in preoperative bay. In the acupuncture group, the acupuncture pads contain a small (0.15mm x 0.6mm) embedded needle in-situ. In the control group, the sham acupuncture pads look identical but the needle has already been removed prior to insertion. These are left in-situ for 5 days and removed by patients at home. Intraoperatively, in the acupuncture group, body acupuncture needles (0.18mm x 15mm) are applied at 10 specified points immediately after induction of anaesthesia. These are removed after surgery and before the patients wake up. In the control group, no body acupuncture needles are given. Postoperative pain relief consisted of regular Paracetamol and Oxycodone as required. All patients and nursing staffs are blinded. All assessors evaluated postoperative pain using the 0-10 Numerical pain scale. Pain scores were recorded at regular intervals during the first 24 hours by nurses in hospital and on day 1,2 and 5 following discharge by patients at home.

Interventions

Intervention: Intraoperative acupuncture during tonsillectomy procedure Why: To assess if intraoperative acupuncture can affect postoperative pain score How: With approval from the Hospital Ethics Committees, we plan to enroll 260 adults who are undergoing tonsillectomy into our study. All prospective patients receive written informed consent prior to surgery. All patients are interviewed and consented by the anaesthetist the night before or on the day of surgery. They are all given a chance

Intervention: Intraoperative acupuncture during tonsillectomy procedure Why: To assess if intraoperative acupuncture can affect postoperative pain score How: With approval from the Hospital Ethics Committees, we plan to enroll 260 adults who are undergoing tonsillectomy into our study. All prospective patients receive written informed consent prior to surgery. All patients are interviewed and consented by the anaesthetist the night before or on the day of surgery. They are all given a chance to ask questions at the interview and any further queries are to be addressed prior to the procedure. All patients have their intravenous cannula inserted in the induction bay and also have 5 auricular acupuncture needles pads attached to each ear. In the acupuncture group, the Serin paper needle pads with a very small (0. 6mm) embedded needles are used. In the control group, the sham paper pads without needles were used instead. The needles in these sham paper pads were removed by the author prior to the operation day. In all patients, these needle pads are to remained in place for 5 days, and then removed by patients at home. The patients are then brought into the operating room for induction of anaesthesia. In the acupuncture group, immediately following induction of anaesthesia and prior to surgical stimulation, ten (10) body acupuncture needles are inserted prior to surgical stimulation. A standard surgical tonsillectomy with diathermy is then carried out. At the end of surgery, the body acupuncture needles are removed. The patients are then woken up and taken out to recovery. In the control group, an identical procedure to that described above was followed, without the insertion of ten (10) acupuncture needles. What: For auricular acupuncture, paper pads with an embedded needle 0.2mm in diameter and 0.6mm in length were used (Serin Co, Shizuoka, Japan). In the control group, the needles were removed with a surgical needle holder by the author prior to the operation day to provide sham paper pads without needles. For body acupuncture: Stainless steel acupuncture needles, 15 mm in length and 0.18 mm in diameter (Serin Co, Shizuoka, Japan), were used. 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 When/How much: All acupuncture is done only once.The body acupuncture 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. The auricular acupuncture needles are left in-situ for 5 days postoperative and removed by patients at home. Documentation/ Monitoring: All patients enrolled are noted to have acupuncture (AC) intervention recorded on their anaesthetic record. A separate record for their in-hospital Pains Scores are included in their Medical Record which is filled out by nursing staff and doubled check against their own Pain Scores on hospital ward chart and Oxycodone does on the Medication chart. Another record is given for patients to record their Pain Scores and Oxycodone doses at home. Both of these are collected and collated by the research nurses when completed. Immediately after the removal of acupuncture needles, all insertion sites are inspected for possible bleeding or erythema. These common complications are recorded on the acupuncture collection sheets, as well as any reported rare complications such as neurological impairment.

Sponsors

Dr David Ho
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Healthy adults undergoing tonsillectomy

Exclusion criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026