Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410332
Status:
UNKNOWN
Last Update Posted:
2012-02-22
First Post:
2006-12-11
Brief Title:
Traumeel for Post-Tonsillectomy Pain
Sponsor:
Shaare Zedek Medical Center
Organization:
Shaare Zedek Medical Center
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2012-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dayuntil 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 34 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
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 dayuntil 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 34 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None