Post-Tonsillectomy Clinical Trial
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.
| NCT number | NCT00410332 |
| Other study ID # | 32/6 |
| Secondary ID | |
| Status | Recruiting |
| Phase | Phase 3 |
| First received | December 11, 2006 |
| Last updated | February 19, 2012 |
| Start date | March 2011 |
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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Dept. of Ear, Nose and Throat Medicine, Shaare Zedek Medical Center | Jerusalem |
| Lead Sponsor | Collaborator |
|---|---|
| Shaare Zedek Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | postoperative pain, as registered on the NRS | 14d | Yes | |
| Secondary | analgesic use (dipyrone) | 14d | Yes | |
| Secondary | post-operative bleeding (quantified on a scale of 1-4) | 14d | Yes | |
| Secondary | nocturnal awakenings | 14d | Yes | |
| Secondary | time to resumption of eating and return to normal activity | 14d | Yes | |
| Secondary | cytokine levels (CRP, IL-6) at 36 hours postoperative | 14d | No | |
| Secondary | side effects of the treatment. | 14d | Yes |