Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
Shaare Zedek Medical Center |
---|---|
Information provided by: | Shaare Zedek Medical Center |
ClinicalTrials.gov Identifier: | NCT00410332 |
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
Condition | Intervention | Phase |
---|---|---|
Post-Tonsillectomy |
Drug: Traumeel S Drug: TRAUMEEL S Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 20 |
Study Start Date: | September 2009 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Active Comparator
TRAUMEEL S
|
Drug: Traumeel S
homeopathic remedy
Drug: TRAUMEEL S
homeopathic remedy
|
B: Placebo Comparator |
Drug: Placebo
placebo drug, identical in size, form and taste as treatment remedy
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Menachem Oberbaum, M.D. | 972-2-6666395 | oberbaum@szmc.org.il |
Israel | |
Dept. of Ear, Nose and Throat Medicine, Shaare Zedek Medical Center | |
Jerusalem, Israel, 91031 |
Principal Investigator: | Menachem Oberbaum, M.D. | Shaare Zedek Medical Center, Jerusalem, Israel |
Responsible Party: | Shaare Zedek Medical Center, Jerusalem, Israel ( Menachem Oberbaum, MD ) |
Study ID Numbers: | 32/6 |
Study First Received: | December 11, 2006 |
Last Updated: | April 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00410332 History of Changes |
Health Authority: | Israel: Ministry of Health, Pharmaceutical Division. |
tonsillectomy pain homeopathy Traumeel |
Pain |