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Acupuncture for Post-tonsillectomy Pain Control in Children

NCT01285687 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-07-01

No results posted yet for this study

Summary

A randomized, controlled, single-blinded study comparing conventional postoperative analgesia with paracetamol-on-demand with the same regime plus acupuncture.

The hypothesis is that postoperative treatment of children undergoing tonsillectomy with acupuncture will reduce pain with minimal unwanted effects.

Conditions

  • Tonsillectomy
  • Post-Operative Pain
  • Acupuncture

Interventions

DEVICE

acupuncture

Sterile, disposable, FDA-approved acupuncture needles will be used. Acupuncture will be performed bilaterally. The needles will penetrate the skin to a depth of 5-10mm and will be kept in place for no more than 5 minutes. The acupuncture points will be: Li 4, Li 11, St 44, according to Chinese acupuncture mapping. Treatment will be repeated at least 3 times during the hospital stay. Treatment will start in the pediatrics department approximately two hours after discharge from the postoperative unit. The 2nd treatment will be given on the same evening, approximately 4-8 hours after the 1st treatment and the 3rd treatment will be given the following morning, approximately 12-18 hours after the 2nd treatment. Exact treatment times will be recorded in the patient's file.

Sponsors & Collaborators

  • Ziv Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01285687 on ClinicalTrials.gov