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Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01790477
First Posted: February 13, 2013
Last Update Posted: April 6, 2016
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.
Information provided by (Responsible Party):
United States Naval Medical Center, San Diego
  Purpose
The goal of this study is to assess the role of battlefield acupuncture in the reduction of pain scores status post adult tonsillectomy. Secondary goals of this study include reduction in narcotic usage, decreased nausea and vomiting, and evaluating patient factors that lend an increased risk of worsening pain or improved response with acupuncture.

Condition Intervention
Recurrent Tonsillitis Peritonsillar Abscess Obstructive Sleep Apnea Procedure: Auricular Acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Auricular Acupuncture for The Treatment of Post-Tonsillectomy Pain

Resource links provided by NLM:


Further study details as provided by United States Naval Medical Center, San Diego:

Primary Outcome Measures:
  • Reduction in VAS scores between experimental and control group [ Time Frame: 2 weeks ]

Enrollment: 134
Study Start Date: November 2012
Study Completion Date: February 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Auricular Acupuncture
Use of auricular acupuncture in bilateral ears
Procedure: Auricular Acupuncture
Application of auricular acupuncture to 5 points on the ear
No Intervention: Control

  Eligibility

Information from the National Library of Medicine

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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:

  • Any adult patient who meets criteria and is scheduled for tonsillectomy

Exclusion Criteria:

  • Any patient with prior use of acupuncture
  • Individuals under age 18
  • Tonsillectomy performed with other surgical procedures, i.e UPPP, adenoidectomy,
  • Patients with a known personal or family history of a bleeding disorder will be excluded.
  • Patients with a history of kidney or liver problems will also be excluded.
  • Patients found to be pregnant will be excluded from participation.
  • Patients unwilling to enroll in the study will have the tonsillectomy with or without adenoidectomy performed according to current practice standards.
  Contacts and Locations
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): NCT01790477


Locations
United States, California
NMCSD Balboa
San Diego, California, United States, 92104
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Investigators
Principal Investigator: Anil Shah NMCSD
  More Information

Responsible Party: United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT01790477     History of Changes
Other Study ID Numbers: NMCSD.2012.0102
First Submitted: February 11, 2013
First Posted: February 13, 2013
Last Update Posted: April 6, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by United States Naval Medical Center, San Diego:
Tonsillectomy
Acupuncture

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Tonsillitis
Peritonsillar Abscess
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Abscess
Suppuration
Infection