Clinical trial NCT02571075: Battlefield Auricular Acupuncture During Adult Tonsillectomies and Effect of Post op Pain and Nausea
Official title: A Randomized, Single-blind, Prospective Trial of Auricular Acupuncture for the Reduction of Post-operative Tonsillectomy Pain in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tonsillitis
Keywords: auricular
acupuncture
pain
Lead sponsor: Defense and Veterans Center for Integrative Pain Management
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Pain Scores
timeFrame: 10 days after the procedure.
measure: The Morphine Equivalent of Opioid Use
timeFrame: Intraoperative to 10 days post operative utilizing the Johns Hopkins Opioid conversion system.
Secondary outcomes:
measure: Return to Diet
timeFrame: Within 10 days post operatively
measure: Number of Participants With Nausea Post Operatively
timeFrame: 1-3 hours postoperativey
measure: Number of Participants With Nausea Post Operatively
timeFrame: 1-3 hours post operatively
Other outcomes:
Locations:
city: Fort Bragg
country: United States
facility: Womack Army Medical Center
state: North Carolina
Study officials:
affiliation: Womack Army Medical Center Fort Bragg
name: Anthony R Plunkett, MD
role: PRINCIPAL_INVESTIGATOR
References: