Battlefield Auricular Acupuncture During Adult Tonsillectomies and Effect of Post op Pain and Nausea (BFA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02571075|
Recruitment Status : Completed
First Posted : October 8, 2015
Results First Posted : August 28, 2019
Last Update Posted : June 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Tonsillitis||Other: Auricular acupuncture||Not Applicable|
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)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Primary Completion Date :||June 8, 2017|
|Actual Study Completion Date :||August 23, 2017|
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.
- 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 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.
- 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.
- 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)
- Number of Participants With 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.
- Number of Participants With Nausea 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.
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
|United States, North Carolina|
|Womack Army Medical Center|
|Fort Bragg, North Carolina, United States, 28310|
|Principal Investigator:||Anthony R Plunkett, MD||Womack Army Medical Center Fort Bragg|