Clinical trial NCT00410332: Traumeel for Post-Tonsillectomy Pain
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Post-Tonsillectomy
Keywords: tonsillectomy
pain
homeopathy
Traumeel
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2006-12-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: postoperative pain, as registered on the NRS
timeFrame: 14d
Secondary outcomes:
measure: analgesic use (dipyrone)
timeFrame: 14d
measure: post-operative bleeding (quantified on a scale of 1-4)
timeFrame: 14d
measure: nocturnal awakenings
timeFrame: 14d
measure: time to resumption of eating and return to normal activity
timeFrame: 14d
measure: cytokine levels (CRP, IL-6) at 36 hours postoperative
timeFrame: 14d
measure: side effects of the treatment.
timeFrame: 14d
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Dept. of Ear, Nose and Throat Medicine, Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center, Jerusalem, Israel
name: Menachem Oberbaum, M.D.
role: PRINCIPAL_INVESTIGATOR
References: