Acupuncture for Tonsillectomy Pain

Postoperative Pain Clinical Trial

Official title:

Acupuncture for Tonsillectomy Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389349
• Other study ID #: 2322
• Status: Completed
• Phase: N/A
• First received: July 6, 2011
• Last updated: May 17, 2012
• Start date: July 2011
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Children's ENT of San Diego, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 17 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Other:
• Acupuncture
Battlefield acupuncture protocol
• Sham Control
Sham control acupuncture

Locations

Country	Name	City	State
United States	Children's Specialty Clinic	El Centro	California
United States	Rady Children's Hospital San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Children's ENT of San Diego, Inc.	Rady Children's Hospital, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No