Acupuncture for Tonsillectomy Pain
1 other identifier
interventional
130
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2011
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 6, 2011
CompletedFirst Posted
Study publicly available on registry
July 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedMay 18, 2012
May 1, 2012
10 months
July 6, 2011
May 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Acupuncture
EXPERIMENTALSham Control
SHAM COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Children 2 to 17 years of age who need tonsillectomy with or without adenoidectomy with or without myringotomy tube(s)
You may not qualify if:
- Developmental Delay
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Children's Specialty Clinic
El Centro, California, 92243, United States
Rady Children's Hospital San Diego
San Diego, California, 92123, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
July 6, 2011
First Posted
July 8, 2011
Study Start
July 1, 2011
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
May 18, 2012
Record last verified: 2012-05