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

Tonsillitis Clinical Trial

— BFA  

Official title:

A Randomized, Single-blind, Prospective Trial of Auricular Acupuncture for the Reduction of Post-operative Tonsillectomy Pain in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571075
• Other study ID #: 381600
• Status: Completed
• Phase: N/A
• Start date: November 2013
• Est. completion date: August 23, 2017

Study information

• Verified date: May 2020
• Source: Defense and Veterans Center for Integrative Pain Management
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: August 23, 2017
• Est. primary completion date: June 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tonsillitis

Intervention

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.

Locations

Country	Name	City	State
United States	Womack Army Medical Center	Fort Bragg	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Defense and Veterans Center for Integrative Pain Management

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Return to Diet	Subjects will record on their diary the date they returned to a regular diet (defined to them what is regular for them)	Within 10 days post operatively
Secondary	Number of Participants With Nausea Post Operatively	It will be documented yes or no if the participant voiced any complaint of nausea while in recovery.	1-3 hours postoperativey
Secondary	Number of Participants With Nausea Post Operatively	It will be documented yes or no if the participant had any emesis while in recovery prior to discharge home.	1-3 hours post operatively