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Acupuncture for Tonsillectomy Pain

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ClinicalTrials.gov Identifier: NCT01389349
Recruitment Status : Completed
First Posted : July 8, 2011
Last Update Posted : May 18, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Pain after tonsillectomy can be severe and last ten days.

Various new surgical instruments have been developed over the years in an attempt to reduce postoperative pain with mixed results and increased costs; no single tonsillectomy technique is superior to the rest. Patients are discharged to home usually on the day of surgery and often suffer significant pain and nausea. Pain medication is often prescribed which can cause nausea, vomiting and constipation. Children in pain are reluctant to take in fluids and may require intravenous hydration at an emergency department.

"Battlefield acupuncture " has been recently developed by the US Air Force and is now being used in Iraq and Afghanistan on wounded warriors suffering severe acute pain from trauma. This protocol consists of five acupuncture points on the outer ear.

A recent study has demonstrated decreased pain and agitation in children undergoing ear tube insertion. Ear tube patients have mild discomfort compared to tonsillectomy patients and are able to attend school the next day.

The investigators have been encouraged by the benefits of acupuncture during surgery for ear tube patients and also wounded warriors recovering from their injuries. These findings motivated us to see if acupuncture during tonsillectomy surgery would result in less pain and nausea.


Condition or disease Intervention/treatment
Children Postoperative Pain Tonsillar Hypertrophy Obstructive Sleep Apnea Chronic Tonsillitis Other: Acupuncture Other: Sham Control

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Acupuncture for Tonsillectomy Pain
Study Start Date : July 2011
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Acupuncture Other: Acupuncture
Battlefield acupuncture protocol
Sham Comparator: Sham Control Other: Sham Control
Sham control acupuncture


Outcome Measures

Primary Outcome Measures :
  1. Pain Response [ Time Frame: Postoperative days 1 and 6 ]
    Families will be contacted via telephone by a member of the study team other than Dr. Ochi on postoperative days 1 and 6. During these follow-up phone calls a member of the study team will review the daily diary with the parent and also inquire about oral intake, activity level, complications and any additional medical encounters.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 2 to 17 years of age who need tonsillectomy with or without adenoidectomy with or without myringotomy tube(s)

Exclusion Criteria:

  • Developmental Delay
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): NCT01389349


Locations
United States, California
Children's Specialty Clinic
El Centro, California, United States, 92243
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
Sponsors and Collaborators
Children's ENT of San Diego, Inc.
Rady Children's Hospital, San Diego
More Information

Responsible Party: James W Ochi, M.D., Physician, Children's ENT of San Diego, Inc.
ClinicalTrials.gov Identifier: NCT01389349     History of Changes
Other Study ID Numbers: 2322
First Posted: July 8, 2011    Key Record Dates
Last Update Posted: May 18, 2012
Last Verified: May 2012

Keywords provided by James W Ochi, M.D., Children's ENT of San Diego, Inc.:
tonsillectomy
adenotonsillectomy
acupuncture
children
postoperative pain
postoperative nausea

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Pain, Postoperative
Hypertrophy
Tonsillitis
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Pain
Neurologic Manifestations
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pathological Conditions, Anatomical
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases