Acupuncture for Tonsillectomy Pain

NCT ID: NCT01389349

Last Updated: 2012-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Children Postoperative Pain Tonsillar Hypertrophy Obstructive Sleep Apnea Chronic Tonsillitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Acupuncture

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

Battlefield acupuncture protocol

Sham Control

Group Type SHAM_COMPARATOR

Sham Control

Intervention Type OTHER

Sham control acupuncture

Interventions

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Acupuncture

Battlefield acupuncture protocol

Intervention Type OTHER

Sham Control

Sham control acupuncture

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rady Children's Hospital, San Diego

OTHER

Sponsor Role collaborator

Children's ENT of San Diego, Inc.

OTHER

Sponsor Role lead

Responsible Party

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James W Ochi, M.D.

Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Children's Specialty Clinic

El Centro, California, United States

Site Status

Rady Children's Hospital San Diego

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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2322

Identifier Type: -

Identifier Source: org_study_id

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