Traumeel for Post-Tonsillectomy Pain

Study Overview
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Brief Summary
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Tonsillectomy is one the most common procedures in ear, nose and throat (ENT) medicine. Following surgery patients suffer from severe pain and difficulty on swallowing, while analgesic treatment has limited efficacy and potential adverse effects such as increased bleeding with NSAIDs. Traumeel S is a homeopathic complex remedy used primarily in Europe for the treatment of pain and inflammation. It contains a number of plants and minerals at high dilutions (between 1x10-2 to 1x10-8), and has been shown to exhibit anti-inflammatory properties such as cytokine inhibition in human T cells, monocytes and gut epithelial cells. Clinical studies have found Traumeel S reduces post-chemotherapy stomatitis, as well as post-surgical inflammation and pain following orthopedic procedures. The purpose of this study is to examine the effect of Traumeel S on post-tonsillectomy pain in adult patients. The study group will consist of 20 patients age 18 years of age and older following elective tonsillectomy. These patients will be randomly assigned to receive treatment with either true Traumeel S remedies or placebo. One ampule of Traumeel S (or placebo) will be sprayed over the resected area immediately following surgery. Two Traumeel S (or placebo) tablets will be taken subsequently 4 times daily (Total: 8 tablets per day)until no analgesics are required for 2 consecutive days, or until Day 14 (whichever comes first). Patients will be allowed to take dipyrone (Optalgin) 500mg tablets on an as-needed basis, for up to 14 days postoperatively. At the end of this period, a thorough ENT examination will be done. The primary parameter to be evaluated in the study will be postoperative pain, as registered on a numerical pain rating scale (NRS), to be filled prior to surgery. In the post-anesthesia care unit (PACA) the NRS will be filled out again, this time for pain at rest and then again for pain upon swallowing - at 1, 2, 3,4 and 24 hours postoperatively. Secondary parameters to be evaluated are: analgesic use (dipyrone); post-operative bleeding (quantified on a scale of 1-4); nocturnal awakenings; time to resumption of eating and return to normal activity; cytokine levels (CRP, IL-6) at 36 hours postoperative; and side effects of the treatment.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Pilot Study for Evaluating the Efficacy of the Homeopathic Remedy Traumeel S on Pain Reduction Following Tonsillectomy in Adult Patients.

Conditions
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Post-Tonsillectomy

Intervention / Treatment
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* Drug: Traumeel S
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older Recurrent tonsillitis or obstructive tonsillar hypertrophy requiring tonsillectomy. Exclusion Criteria: Elective or emergency tonsillectomy for a reason other than those listed above. History of peritonsillar abscess, or need for additional ENT procedures (adenoidectomy, uvulectomy) Pregnancy, breastfeeding Asthma, Epilepsy Concurrent illness with impairment of wound-healing (diabetes, vascular disease) allergy or contraindication to use of protocol medication (dipyrone) inability to comply with the protocol conditions.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>TRAUMEEL S | Drug: Traumeel S<br>* homeopathic remedy<br>|
| Placebo Comparator: B<br> | Drug: Placebo<br>* placebo drug, identical in size, form and taste as treatment remedy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain, as registered on the NRS |  | 14d | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic use (dipyrone) |  | 14d | 
| post-operative bleeding (quantified on a scale of 1-4) |  | 14d | 
| nocturnal awakenings |  | 14d | 
| time to resumption of eating and return to normal activity |  | 14d | 
| cytokine levels (CRP, IL-6) at 36 hours postoperative |  | 14d | 
| side effects of the treatment. |  | 14d | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tonsillectomy, pain, homeopathy, Traumeel