Traumeel for Post-Tonsillectomy Pain

NCT ID: NCT00410332

Last Updated: 2012-02-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31

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.

Conditions

Post-Tonsillectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

A

TRAUMEEL S

Group Type: ACTIVE_COMPARATOR

Traumeel S

Intervention Type: DRUG

homeopathic remedy

B

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo drug, identical in size, form and taste as treatment remedy

Interventions

Traumeel S

homeopathic remedy

Intervention Type: DRUG

Placebo

placebo drug, identical in size, form and taste as treatment remedy

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaare Zedek Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Menachem Oberbaum

Director, Center for Integrative Complementary Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Menachem Oberbaum, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shaare Zedek Medical Center, Jerusalem, Israel

Locations

Dept. of Ear, Nose and Throat Medicine, Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Menachem Oberbaum, M.D.

Role: CONTACT

oberbaum@szmc.org.il

972-2-6666395

Facility Contacts

Menachem Oberbaum, M.D.

Role: primary

oberbaum@szmc.org.il

972-2-6666395

Other Identifiers

32/6

Identifier Type: -

Identifier Source: org_study_id