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
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||Phase|
|Children Postoperative Pain Tonsillar Hypertrophy Obstructive Sleep Apnea Chronic Tonsillitis||Other: Acupuncture Other: Sham Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Acupuncture for Tonsillectomy Pain|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Battlefield acupuncture protocol
|Sham Comparator: Sham Control||
Other: Sham Control
Sham control acupuncture
- 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.
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
|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|