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Acupuncture for Tonsillectomy Pain

Primary Purpose

Children, Postoperative Pain, Tonsillar Hypertrophy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sham Control
Sponsored by
Children's ENT of San Diego, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Children focused on measuring tonsillectomy, adenotonsillectomy, acupuncture, children, postoperative pain, postoperative nausea

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Specialty Clinic
  • Rady Children's Hospital San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupuncture

Sham Control

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 6, 2011
Last Updated
May 17, 2012
Sponsor
Children's ENT of San Diego, Inc.
Collaborators
Rady Children's Hospital, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT01389349
Brief Title
Acupuncture for Tonsillectomy Pain
Official Title
Acupuncture for Tonsillectomy Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's ENT of San Diego, Inc.
Collaborators
Rady Children's Hospital, San Diego

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children, Postoperative Pain, Tonsillar Hypertrophy, Obstructive Sleep Apnea, Chronic Tonsillitis
Keywords
tonsillectomy, adenotonsillectomy, acupuncture, children, postoperative pain, postoperative nausea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Title
Sham Control
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Battlefield acupuncture protocol
Intervention Type
Other
Intervention Name(s)
Sham Control
Intervention Description
Sham control acupuncture
Primary Outcome Measure Information:
Title
Pain Response
Description
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.
Time Frame
Postoperative days 1 and 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Children's Specialty Clinic
City
El Centro
State/Province
California
ZIP/Postal Code
92243
Country
United States
Facility Name
Rady Children's Hospital San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

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Acupuncture for Tonsillectomy Pain

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