CompletedPhase 2ACTRN12619000922178

Acupuncture for complementary pain relief following tonsillectomy in children

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


Sponsor

Dr David Ho

Enrollment

258 participants

Start Date

Jun 13, 2016

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 2 YearssMax Age: 10 Yearss

Inclusion Criteria1

  • Healthy children undergoing tonsillectomy

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Interventions

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 un

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.


Locations(2)

North West Brisbane Private Hospital - Everton Park

QLD, Australia

Holy Spirit Northside - Chermside

QLD, Australia

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ACTRN12619000922178


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