None listed
Conditions
Brief summary
The primary objective is to test the efficacy and feasibility of Battlefield (ear) acupuncture (BFA) as an adjunct to standard analgesia care performed by usual Emergency Department health care providers. Secondary objectives include acupuncture application time, and changes in: opioid usage, costs, adverse events, and patient satisfaction. It is anticipated that ear acupuncture will be an effective add on to simple analgesia that reduces usage of opioid analgesia and improves patient satisfaction.
Interventions
Arm 1 Ten ASP (Aigulle Acupuncture semi-Permanent) gold needles inserted according to the Battlefield ear acupuncture protocol (5 needles each ear i.e. cingulate gyrus, thalamus, omega, point zero and Shenmen), needles concealed with 10 DuoDerm tapes and then also receive standard analgesia care (see below). Acupuncture practitioners will be usual health care providers i.e. non-acupuncturists (emergency doctors, nurse practitioners, registered nurses) trained by the principal investigator (a registered medical acupuncturist). Reference Battlefield ear acupuncture protocol: Niemtzow RC. Battlefield acupuncture. Medical Acupuncture. 2007 Dec 1;19(4):225-8. Note: Duoderm tapes are cut into approximately 1cm squares with a central mark to obscure needle. Product information on extra thin Duoderm dressings can be obtained from: https://www.convatec.com.au/advanced-wound-care/duoderm-dressings/duoderm-extra-thin-dressing/ Arm 2 The second arm or sham group will have a piezoelectric device (Pulsar Plus Piezo Stimulator) sounded adjacent (1-2cm) to but not onto the ear. Normally the piezo stimulator generates a single electric impulse by compressing and releasing pressure on a piezo crystal inside the stimulator. However, because it is only activated in the air away from the patient, no electric current enters the patient and the only perceived intervention is a clicking sound - hence used as our sham device. 10 DuoDerm tapes will be applied similarly to the needle intervention arm and then will also receive standard analgesia care (see below). Product information on the Pulsar Plus Piezo Stimulator can be obtained from: https://www.heliosupply.com.au/index.php/electro-laser/stimulators-point-locators/electrical-leads-wq001-2.html Arm 3 The third arm is the standard analgesia care group alone. This group will have standard analgesia care and 10 DuoDerm tapes also applied. Standard usual analgesic care consists of: Patients with a NPRS-10 greater or equal to 4 and less than or equal to 7 will receive paracetamol 1g orally / intravenously and Ibuprofen 400-800mg orally or Ketorolac 10mg intravenously / 15mg intramuscularly pending last dose of relevant / same analgesic. Rescue medication is oral / under the tongue opioid after 30 minutes’ post triage: Oxycodone 5-10mg orally, Buprenorphine 200-400mcg under the tongue or Tapentadol IR 50 – 100mg orally. Antiemetic if nauseated Patients with a NPRS-10 > 7 will receive above regime for paracetamol / non-steroidal anti-inflammatory and rapid acting opioid: Fentanyl 1.5mcg/Kg/dose intranasally – max 2 doses or intravenously, Fentanyl 25mcg boluses to 100mcg total intravenously or Morphine 1-2.5mg boluses to 10mg total intravenously. Further rescue doses of Fentanyl intravenously, Morphine intravenously and Oxycodone 5-10mg orally. Antiemetic if nauseated The expected duration of application of the ear needles per patient is approximately 4 minutes. This application time is a secondary outcome. Needles will remain in situ for 2 hours and then removed.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients attending the emergency department with acute pain (a NPRS-10 greater than or equal to 4 at rest) of the: lower back, abdominal condition, or limb trauma, triage categories 3-5
Exclusion criteria
• Triage category 1 or 2 • Unable to comprehend consent due to a barrier in language (eg failure to access a quality translator) or cognition • Immediate medical intervention required • Pregnant • Chronic pain (defined as on opioids and or pain is greater than 6 weeks’ duration) • Chest pain • Immune deficiency • On anticoagulants such as warfarin, novel anticoagulants e.g. apixaban, dabigatran, rivaroxaban and anti-platelet agents clopidogrel, ticagrelor and prasugrel. Those on aspirin however, can be included. • Artificial heart valve • Permanent pacemaker • Needle phobia • Allergy to gold or tapes • Known blood borne pathogen eg HIV, Hep C and Hep B antigen positive. • Recent ear infection or trauma • Deafness or uses hearing aids