Battlefield Auricular Acupuncture During Adult Tonsillectomies and Effect of Post op Pain and Nausea

NCT02571075 | Completed Results

• 1 other identifier: 381600
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if auricular acupuncture significantly reduces post-operative pain in comparison to the standard of care. Post-operative pain score will be collected by subject self-report of pain according to the Numerical Rating Scale (NRS) (0= no pain, 10 = worst imaginable pain) up to 10 days post-operation.

Conditions

Tonsillitis

Keywords

auricular; acupuncture; pain

Outcome Measures

Primary Outcomes (2)

• Pain Scores

  Pain scores will be collected daily during the post op period in the recovery room using a numbers scale with faces; specifically the Wong-Baker FACES® Pain Rating Scale where 10 is described as worst possible and 0 is No pain. This was recorded by the participant at home using the same type scale and this was is provided to them. The Hypothesis is that subjects receiving intraoperative auricular acupuncture during a tonsillectomy will have statistically significantly less post-operative pain scores compared to those that do not.

  10 days after the procedure.

• The Morphine Equivalent of Opioid Use

  The intraoperative and recovery room morphine equivalents will be calculated and upon diary return what use is recorded by the patient will be done as well. The participant is instructed to write down the type and amount they take throughout that time period.

  Intraoperative to 10 days post operative utilizing the Johns Hopkins Opioid conversion system.

Secondary Outcomes (3)

• Return to Diet

  Within 10 days post operatively

• Number of Participants With Nausea Post Operatively

  1-3 hours postoperativey

• Number of Participants With Nausea Post Operatively

  1-3 hours post operatively

Study Arms (2)

Group 1 - Receives auricular acupuncture

EXPERIMENTAL

Receives "Battlefield Acupuncture" (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened.

Other: Auricular acupuncture

Group 2 don't receive anything

NO INTERVENTION

They do not receive any any acupuncture only standard of care.

Interventions

Auricular acupuncture OTHER

The ear will be cleaned with alcohol prior to insertion of the needles. Five sterile, single-use, gold needles will be placed in each ear according to the figure below. The needles penetrate about a millimeter (or 4/100ths of an inch) into the skin.

Also known as: "Battlefield Acupuncture" BFA

Group 1 - Receives auricular acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adults eighteen years of age or older having a tonsillectomy with or without adenoidectomy
• Anesthesiologist classification one to three

You may not qualify if:

• Chronic pain syndromes or pain symptoms lasting greater than three months or taking opioids on a daily basis for greater than four months
• Anesthesiologist classification four
• Prior neck or throat surgery
• Allergy to gold

Sponsors & Collaborators

• Defense and Veterans Center for Integrative Pain Management: lead

Study Sites (1)

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

Location

MeSH Terms

Conditions

Tonsillitis; Pain

Interventions

Acupuncture, Ear

Condition Hierarchy (Ancestors)

Pharyngitis; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Limitations and Caveats

Of the 95 enrolled there was only a 50% diary return of the 10 day diaries and not all of those were complete.

Results Point of Contact

• Title: Anthony Plunkett
• Organization: Womack Army Medical Center

anthony.r.plunkett.civ@mail.mil

910-643-2324

Study Officials

• Anthony R Plunkett, MD

  Womack Army Medical Center Fort Bragg

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 8, 2015
• Study Start: November 1, 2013
• Primary Completion: June 8, 2017
• Study Completion: August 23, 2017
• Last Updated: June 9, 2020
• Results First Posted: August 28, 2019

Record last verified: 2020-05

Locations

US (1)