Acupuncture for Post-tonsillectomy Pain Control in Children

Not Applicable

Completed

• Conditions: Acupuncture; Tonsillectomy; Post-Operative Pain
• Interventions: Device: acupuncture

• Registration Number: NCT01285687
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-23
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-28
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-30
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Analgesic Treatment with Acupuncture	acupuncture	Patients will receive standard analgesic treatment and in addition acupuncture.

Primary Outcome Measures

Name	Time	Method
Post-Operative Pain	48 hours post-surgery

Secondary Outcome Measures

Name	Time	Method
Analgesic Drug Consumption	48 hours post-surgery

Trial Locations

Locations (1)

Ziv Medical Center; 🇮🇱 Safed, Israel