Tonsillitis Clinical Trial
Official title:
A Randomized, Single-blind, Prospective Trial of Auricular Acupuncture for the Reduction of Post-operative Tonsillectomy Pain in Adults
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.
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.
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