Acupuncture for Post-tonsillectomy Pain Control in Children

NCT01285687 | Completed DMC

• 1 other identifier: 0076-09-ZIV
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsillectomy; Post-Operative Pain; Acupuncture

Keywords

Tonsillectomy; Post-Operative Pain; Acupuncture

Outcome Measures

Primary Outcomes (1)

• Post-Operative Pain

  48 hours post-surgery

Secondary Outcomes (1)

• Analgesic Drug Consumption

  48 hours post-surgery

Study Arms (2)

Standard Analgesic Treatment

NO INTERVENTION

Standard Analgesic Treatment with Acupuncture

EXPERIMENTAL

Patients will receive standard analgesic treatment and in addition acupuncture.

Device: acupuncture

Interventions

acupuncture DEVICE

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.

Standard Analgesic Treatment with Acupuncture

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ziv Hospital: lead

Study Sites (1)

Ziv Medical Center

Safed, 13100, Israel

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2011
• First Posted: January 28, 2011
• Study Start: January 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: July 1, 2015

Record last verified: 2015-06

Locations

IL (1)