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Acupuncture for Post-tonsillectomy Pain Control in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Ziv Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01285687
First received: January 23, 2011
Last updated: January 26, 2011
Last verified: January 2011
History of Changes
  Purpose

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 Intervention
Tonsillectomy
Post-Operative Pain
Acupuncture
 Device: acupuncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture for Post-tonsillectomy Pain Control in Children: a Single-blinded, Randomized, Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ziv Hospital:

Primary Outcome Measures:
  • Post-Operative Pain [ Time Frame: 48 hours post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analgesic Drug Consumption [ Time Frame: 48 hours post-surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2011
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   3 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01285687

Contacts
Contact: Peter Gilbey, Dr 972-50-8434014 peter.g@ziv.health.gov.il

Locations
Israel
Ziv Medical Center
Safed, Israel, 13100
Sponsors and Collaborators
Ziv Hospital
  More Information

No publications provided

Responsible Party: Dr Peter Gilbey, Ziv Medical Center, Safed, Israel
ClinicalTrials.gov Identifier: NCT01285687     History of Changes
Other Study ID Numbers: 0076-09-ZIV
Study First Received: January 23, 2011
Last Updated: January 26, 2011
Health Authority: Israel: Institutional Oversight Authority
Israel: Ministry of Health

Keywords provided by Ziv Hospital:
Tonsillectomy
Post-Operative Pain
Acupuncture

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013