Acupuncture for Post-tonsillectomy Pain Control in Children

Acupuncture for Post-tonsillectomy Pain Control in Children: a Single-blinded, Randomized, Controlled Study

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.

Study Overview

• Status: Completed
• Conditions: Acupuncture; Tonsillectomy; Post-Operative Pain
• Intervention / Treatment: Device: acupuncture

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
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Safed, Israel, 13100
    • Ziv Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post-Operative Pain	48 hours post-surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Analgesic Drug Consumption	48 hours post-surgery

Collaborators and Investigators

• Sponsor: Ziv Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: January 23, 2011
• First Submitted That Met QC Criteria: January 26, 2011
• First Posted (Estimate): January 28, 2011

Study Record Updates

• Last Update Posted (Estimate): July 1, 2015
• Last Update Submitted That Met QC Criteria: June 30, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Acupuncture; Tonsillectomy; Post-Operative Pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 0076-09-ZIV