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Trial record 10 of 19 for:    Recruiting, Not yet recruiting, Available Studies | "Tonsillitis"

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

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ClinicalTrials.gov Identifier: NCT02571075
Recruitment Status : Recruiting
First Posted : October 8, 2015
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):
Nancy Kwon, Defense and Veterans Center for Integrative Pain Management

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.

Condition or disease Intervention/treatment Phase
Tonsillitis Other: Auricular acupuncture Not Applicable

Detailed Description:

DESIGN:

Design type: Prospective, randomized control trial Sample

  • Description of the population: All adults, greater than or equal to 18 years, undergoing a tonsillectomy with or without adenoidectomy at Womack Army Medical Center are eligible for participation in the study.
  • Sample Size: 100 subjects. A target of 45 subjects per group for a total of 90 subjects, and accounting for a 10 percent drop out rate. In Fiscal Year 12, 92 tonsilectomies in patients over the age of 12 were performed at Womack Army Medical Center. Therefore, the investigators anticipate the study will take up to 4 years to enroll 100 adult subjects.
  • Power Analysis: Under the assumption of a linear time by treatment interaction, assuming subject-level randomization, five time-points, power of 80 percent, a Type I error rate of 5 per cent and no attrition, to detect a 1.6 difference in pain score requires a total sample size of 90 subjects or 45 per treatment arm.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Single-blind, Prospective Trial of Auricular Acupuncture for the Reduction of Post-operative Tonsillectomy Pain in Adults
Study Start Date : November 2013
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Group 1 - Receives auricular acupuncture
Receives "Battlefield Acupuncture" (BFA) as soon a anesthesia is initiated and needles removed right before they are extubated and awakened.
Other: Auricular acupuncture
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.
Other Name: "Battlefield Acupuncture" BFA
No Intervention: Group 2 don't receive anything
They do not receive any any acupuncture only standard of care.



Primary Outcome Measures :
  1. Pain scores [ Time Frame: 10 days after the procedure. ]
    Pain scores will be collected daily during the post op period in the recovery room using the NRS (numerical pain scale) and recorded by the participant at home using the same type scale that 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.

  2. The morphine equivalent of opioid use [ Time Frame: Intraoperative to 10 days post operative utilizing the Johns Hopkins Opioid conversion system. ]
    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.


Secondary Outcome Measures :
  1. Return to diet [ Time Frame: Within 10 days post operatively ]
    Subjects will record on their diary the date they returned to a regular diet (defined to them what is regular for them)

  2. Nausea post operatively [ Time Frame: 1-3 hours postoperativey ]
    It will be documented yes or no if the participant voiced any complaint of nausea while in recovery.

  3. Vomiting post operatively [ Time Frame: 1-3 hours post operatively ]
    It will be documented yes or no if the participant had any emesis while in recovery prior to discharge home.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571075


Contacts
Contact: Amy M McCoart, BSN 910-907-6239 amy.m.mccoart.ctr@mail.mil
Contact: Anthony R Plunkett, MD 910-907-6000 anthonyrplunkett@gmail.com

Locations
United States, North Carolina
Womack Army Medical Center Recruiting
Fort Bragg, North Carolina, United States, 28310
Contact: Amy M McCoart, BSN    910-907-6239    amy.m.mccoart.ctr@mail.mil   
Contact: Anthony R Plunkett, MD    910-907-6000    anthonyrplunkett@gmail.com   
Sponsors and Collaborators
Defense and Veterans Center for Integrative Pain Management
Investigators
Principal Investigator: Anthony R Plunkett, MD Womack Army Medical Center Fort Bragg

Responsible Party: Nancy Kwon, Research Manager DVCIPM, Defense and Veterans Center for Integrative Pain Management
ClinicalTrials.gov Identifier: NCT02571075     History of Changes
Other Study ID Numbers: 381600
First Posted: October 8, 2015    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017

Keywords provided by Nancy Kwon, Defense and Veterans Center for Integrative Pain Management:
auricular
acupuncture
pain

Additional relevant MeSH terms:
Tonsillitis
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases