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Acupuncture for Tonsillectomy Pain

This study has been completed.
Sponsor:
Collaborator:
Rady Division of Pediatric Critical Care
Information provided by (Responsible Party):
James W Ochi, M.D., Children's ENT of San Diego, Inc.
ClinicalTrials.gov Identifier:
NCT01389349
First received: July 6, 2011
Last updated: May 17, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Children
Postoperative Pain
Tonsillar Hypertrophy
Obstructive Sleep Apnea
Chronic Tonsillitis
 Other: Acupuncture
Other: Sham Control

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Acupuncture for Tonsillectomy Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's ENT of San Diego, Inc.:

Primary Outcome Measures:
  • Pain Response [ Time Frame: Postoperative days 1 and 6 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 130
Study Start Date: July 2011
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture Other: Acupuncture
Battlefield acupuncture protocol
Sham Comparator: Sham Control Other: Sham Control
Sham control acupuncture

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389349

Locations
United States, California
Children's Specialty Clinic
El Centro, California, United States, 92243
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
Sponsors and Collaborators
Children's ENT of San Diego, Inc.
Rady Division of Pediatric Critical Care
  More Information

No publications provided

Responsible Party: James W Ochi, M.D., Physician, Children's ENT of San Diego, Inc.
ClinicalTrials.gov Identifier: NCT01389349     History of Changes
Other Study ID Numbers: 2322
Study First Received: July 6, 2011
Last Updated: May 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's ENT of San Diego, Inc.:
tonsillectomy
adenotonsillectomy
acupuncture
 children
postoperative pain
postoperative nausea

Additional relevant MeSH terms:
Hypertrophy
Pain, Postoperative
Sleep Apnea Syndromes
Tonsillitis
Chronic Disease
Sleep Apnea, Obstructive
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Apnea
 Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Pharyngitis
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Disease Attributes

ClinicalTrials.gov processed this record on June 18, 2013