Acupuncture for Post-tonsillectomy Pain Control in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01285687
Recruitment Status : Completed
First Posted : January 28, 2011
Last Update Posted : July 1, 2015
Information provided by (Responsible Party):
Ziv Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Tonsillectomy Post-Operative Pain Acupuncture Device: acupuncture Not Applicable

Detailed Description:

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

The study will be conducted in accordance with the ethical standards of the Helsinki Declaration and has been approved by the Human Experimentation Ethics Committee of the Ziv Medical Center and the Ministry of Health.

Patients will be recruited through the preoperative clinic conducted on the day before surgery. All parents and children will be given a full explanation of the study by an experienced member of the research team before randomization. The explanation will include the nature of acupuncture and the proposed treatment. Parents will sign an informed consent. Patients randomized to the acupuncture group will have a "trial run" at the time of consenting with a member of the research team experienced with performing acupuncture in children , in order to familiarize the child and family with the procedure.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Post-tonsillectomy Pain Control in Children: a Single-blinded, Randomized, Controlled Study
Study Start Date : January 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Standard Analgesic Treatment
Experimental: Standard Analgesic Treatment with Acupuncture
Patients will receive standard analgesic treatment and in addition acupuncture.
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.

Primary Outcome Measures :
  1. Post-Operative Pain [ Time Frame: 48 hours post-surgery ]

Secondary Outcome Measures :
  1. Analgesic Drug Consumption [ Time Frame: 48 hours post-surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

• children aged 3-12 years undergoing tonsillectomy with or without adenoidectomy for tonsillar hypertrophy with suspected sleep disordered breathing and for recurrent tonsillar infections.

Exclusion Criteria:

  • lack of parental consent
  • skin lesions near acupuncture sites
  • relevant psychiatric disorder
  • coagulopathy
  • drug allergies to regular analgesic treatment
  • intake of medications possibly affecting postoperative pain
  • any child who has received acupuncture treatment in the past or the parents or siblings have received such treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01285687

Ziv Medical Center
Safed, Israel, 13100
Sponsors and Collaborators
Ziv Hospital

Responsible Party: Ziv Hospital Identifier: NCT01285687     History of Changes
Other Study ID Numbers: 0076-09-ZIV
First Posted: January 28, 2011    Key Record Dates
Last Update Posted: July 1, 2015
Last Verified: June 2015

Keywords provided by Ziv Hospital:
Post-Operative Pain

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs