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Acupuncture for Post-tonsillectomy Pain Control in Children

Primary Purpose

Tonsillectomy, Post-Operative Pain, Acupuncture

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
acupuncture
Sponsored by
Ziv Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tonsillectomy focused on measuring Tonsillectomy, Post-Operative Pain, Acupuncture

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ziv Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Analgesic Treatment

Standard Analgesic Treatment with Acupuncture

Arm Description

Patients will receive standard analgesic treatment and in addition acupuncture.

Outcomes

Primary Outcome Measures

Post-Operative Pain

Secondary Outcome Measures

Analgesic Drug Consumption

Full Information

First Posted
January 23, 2011
Last Updated
June 30, 2015
Sponsor
Ziv Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01285687
Brief Title
Acupuncture for Post-tonsillectomy Pain Control in Children
Official Title
Acupuncture for Post-tonsillectomy Pain Control in Children: a Single-blinded, Randomized, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ziv Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tonsillectomy, Post-Operative Pain, Acupuncture
Keywords
Tonsillectomy, Post-Operative Pain, Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Analgesic Treatment
Arm Type
No Intervention
Arm Title
Standard Analgesic Treatment with Acupuncture
Arm Type
Experimental
Arm Description
Patients will receive standard analgesic treatment and in addition acupuncture.
Intervention Type
Device
Intervention Name(s)
acupuncture
Intervention Description
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 Measure Information:
Title
Post-Operative Pain
Time Frame
48 hours post-surgery
Secondary Outcome Measure Information:
Title
Analgesic Drug Consumption
Time Frame
48 hours post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Ziv Medical Center
City
Safed
ZIP/Postal Code
13100
Country
Israel

12. IPD Sharing Statement

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Acupuncture for Post-tonsillectomy Pain Control in Children

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