Traumeel for Post-Tonsillectomy Pain
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|ClinicalTrials.gov Identifier: NCT00410332|
Recruitment Status : Unknown
Verified February 2012 by Menachem Oberbaum, Shaare Zedek Medical Center.
Recruitment status was: Recruiting
First Posted : December 12, 2006
Last Update Posted : February 22, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Post-Tonsillectomy||Drug: Traumeel S Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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.|
|Study Start Date :||March 2011|
|Estimated Primary Completion Date :||December 2012|
Active Comparator: A
Drug: Traumeel S
|Placebo Comparator: B||
placebo drug, identical in size, form and taste as treatment remedy
- postoperative pain, as registered on the NRS [ Time Frame: 14d ]
- analgesic use (dipyrone) [ Time Frame: 14d ]
- post-operative bleeding (quantified on a scale of 1-4) [ Time Frame: 14d ]
- nocturnal awakenings [ Time Frame: 14d ]
- time to resumption of eating and return to normal activity [ Time Frame: 14d ]
- cytokine levels (CRP, IL-6) at 36 hours postoperative [ Time Frame: 14d ]
- side effects of the treatment. [ Time Frame: 14d ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00410332
|Contact: Menachem Oberbaum, M.D.||firstname.lastname@example.org|
|Dept. of Ear, Nose and Throat Medicine, Shaare Zedek Medical Center||Recruiting|
|Jerusalem, Israel, 91031|
|Contact: Menachem Oberbaum, M.D. 972-2-6666395 email@example.com|
|Principal Investigator:||Menachem Oberbaum, M.D.||Shaare Zedek Medical Center, Jerusalem, Israel|