Acupuncture for Tonsillectomy Pain

Sponsor

Children's ENT of San Diego, Inc. (Other)

Overall Status

Completed

CT.gov ID

NCT01389349

Collaborator

Rady Children's Hospital, San Diego (Other)

130

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

6.5

Patients Per Site Per Month

Study Details

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	Phase
Children Postoperative Pain Tonsillar Hypertrophy Obstructive Sleep Apnea Chronic Tonsillitis	Other: Acupuncture Other: Sham Control	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Acupuncture for Tonsillectomy Pain

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

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

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

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.