Acupuncture, Post-Operative Pain, Tonsillectomy
Conditions
Keywords
Tonsillectomy, Post-Operative Pain, Acupuncture
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.
Interventions
DEVICEacupuncture
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.
Sponsors
Ziv Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-Operative Pain | 48 hours post-surgery |
Secondary
| Measure | Time frame |
|---|---|
| Analgesic Drug Consumption | 48 hours post-surgery |
Countries
Israel
Outcome results
None listed