NCT00410332

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2006

Completed
4.2 years until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

February 22, 2012

Status Verified

February 1, 2012

Enrollment Period

1.8 years

First QC Date

December 11, 2006

Last Update Submit

February 19, 2012

Conditions

Post-Tonsillectomy

Keywords

tonsillectomypainhomeopathyTraumeel

Outcome Measures

Primary Outcomes (1)

  • postoperative pain, as registered on the NRS

    14d

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

A

ACTIVE COMPARATOR

TRAUMEEL S

Drug: Traumeel S

B

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Traumeel SDRUG

homeopathic remedy

A
PlaceboDRUG

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

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and older
  • Recurrent tonsillitis or obstructive tonsillar hypertrophy requiring tonsillectomy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jerusalem, 91031, Israel

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Traumeel S

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Menachem Oberbaum, M.D.

    Shaare Zedek Medical Center, Jerusalem, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Menachem Oberbaum, M.D.

CONTACT

972-2-6666395oberbaum@szmc.org.il

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Center for Integrative Complementary Medicine

Study Record Dates

First Submitted

December 11, 2006

First Posted

December 12, 2006

Study Start

March 1, 2011

Primary Completion

December 1, 2012

Last Updated

February 22, 2012

Record last verified: 2012-02

Locations

IL(1)