Traumeel for Post-Tonsillectomy Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Shaare Zedek Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Menachem Oberbaum, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00410332
First received: December 11, 2006
Last updated: February 19, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Post-Tonsillectomy
Drug: Traumeel S
Drug: TRAUMEEL S
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • postoperative pain, as registered on the NRS [ Time Frame: 14d ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • analgesic use (dipyrone) [ Time Frame: 14d ] [ Designated as safety issue: Yes ]
  • post-operative bleeding (quantified on a scale of 1-4) [ Time Frame: 14d ] [ Designated as safety issue: Yes ]
  • nocturnal awakenings [ Time Frame: 14d ] [ Designated as safety issue: Yes ]
  • time to resumption of eating and return to normal activity [ Time Frame: 14d ] [ Designated as safety issue: Yes ]
  • cytokine levels (CRP, IL-6) at 36 hours postoperative [ Time Frame: 14d ] [ Designated as safety issue: No ]
  • side effects of the treatment. [ Time Frame: 14d ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: March 2011
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
TRAUMEEL S
Drug: Traumeel S
homeopathic remedy
Drug: TRAUMEEL S
homeopathic remedy
Placebo Comparator: B Drug: Placebo
placebo drug, identical in size, form and taste as treatment remedy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410332

Contacts
Contact: Menachem Oberbaum, M.D. 972-2-6666395 oberbaum@szmc.org.il

Locations
Israel
Dept. of Ear, Nose and Throat Medicine, Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Contact: Menachem Oberbaum, M.D.    972-2-6666395    oberbaum@szmc.org.il   
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Menachem Oberbaum, M.D. Shaare Zedek Medical Center, Jerusalem, Israel
  More Information

No publications provided

Responsible Party: Menachem Oberbaum, Director, Center for Integrative Complementary Medicine, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00410332     History of Changes
Other Study ID Numbers: 32/6
Study First Received: December 11, 2006
Last Updated: February 19, 2012
Health Authority: Israel: Ministry of Health, Pharmaceutical Division.

Keywords provided by Shaare Zedek Medical Center:
tonsillectomy
pain
homeopathy
Traumeel

ClinicalTrials.gov processed this record on July 23, 2014