Acupuncture for Tonsillectomy Pain

Study Overview
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Brief Summary
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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.

Official Title
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Acupuncture for Tonsillectomy Pain

Conditions
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Children, Postoperative Pain, Tonsillar Hypertrophy, Obstructive Sleep Apnea, Chronic Tonsillitis

Intervention / Treatment
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* Other: Acupuncture
* Other: Sham Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br> | Other: Acupuncture<br>* Battlefield acupuncture protocol<br>|
| Sham Comparator: Sham Control<br> | Other: Sham Control<br>* Sham control acupuncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Response | 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. | Postoperative days 1 and 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tonsillectomy, adenotonsillectomy, acupuncture, children, postoperative pain, postoperative nausea