Traumeel for Post-Tonsillectomy Pain

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.

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.

Study Overview

• Status: Unknown
• Conditions: Post-Tonsillectomy
• Intervention / Treatment: Drug: Traumeel S; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Menachem Oberbaum, M.D.; Phone Number: 972-2-6666395; Email: oberbaum@szmc.org.il

Study Locations

• Israel
  • Jerusalem, Israel, 91031
    • Recruiting
    • Dept. of Ear, Nose and Throat Medicine, Shaare Zedek Medical Center
    • Contact: Menachem Oberbaum, M.D.; Phone Number: 972-2-6666395; Email: oberbaum@szmc.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: B	Drug: Placebo; placebo drug, identical in size, form and taste as treatment remedy
Active Comparator: A; TRAUMEEL S	Drug: Traumeel S; homeopathic remedy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
postoperative pain, as registered on the NRS	14d

Secondary Outcome Measures

Outcome Measure	Time Frame
analgesic use (dipyrone)	14d
post-operative bleeding (quantified on a scale of 1-4)	14d
nocturnal awakenings	14d
time to resumption of eating and return to normal activity	14d
cytokine levels (CRP, IL-6) at 36 hours postoperative	14d
side effects of the treatment.	14d

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Investigators: Principal Investigator: Menachem Oberbaum, M.D., Shaare Zedek Medical Center, Jerusalem, Israel

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: December 11, 2006
• First Submitted That Met QC Criteria: December 11, 2006
• First Posted (Estimate): December 12, 2006

Study Record Updates

• Last Update Posted (Estimate): February 22, 2012
• Last Update Submitted That Met QC Criteria: February 19, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: pain; homeopathy; tonsillectomy; Traumeel
• Other Study ID Numbers: 32/6