Postoperative Pain Clinical Trial
Official title:
Acupuncture for Tonsillectomy Pain
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 |
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.
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Children's Specialty Clinic | El Centro | California |
United States | Rady Children's Hospital San Diego | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Children's ENT of San Diego, Inc. | Rady Children's Hospital, San Diego |
United States,
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 |
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