Acupuncture for Tonsillectomy Pain

Not Applicable

Completed

• Conditions: Children; Postoperative Pain; Tonsillar Hypertrophy; Obstructive Sleep Apnea; Chronic Tonsillitis

• Registration Number: NCT01389349
• Lead Sponsor: Children's ENT of San Diego, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-06
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-08
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-17
• Last Update Posted: 2012-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Response	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.

Trial Locations

Locations (2)

Children's Specialty Clinic; 🇺🇸 El Centro, California, United States

Rady Children's Hospital San Diego; 🇺🇸 San Diego, California, United States