Post-Operative Pain Clinical Trial
Official title:
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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