Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
Not provided
Not provided
Not provided
Not provided
Our primary aim is to determine whether licorice gargling provides meaningful analgesia after oral surgery. Specifically, we propose to test the primary hypothesis that gargling with licorice solution reduces pain after oral surgery more than gargling with sugar water. Because effective analgesia can reduce pain and/or opioid consumption, we will jointly evaluate verbal response pain scores and overall morphine consumption considering licorice to be beneficial only if it proves non-inferior on both measures and superior on at least one.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Licorice | Active Comparator | Licorice gargle |
|
| Sugar water | Placebo Comparator | Sugar gargle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Licorice | Other | ExtractumLiquiritiaeFluidum, 1 g diluted in 30cc water, gargle the solution for 60 seconds without swallowing it starting preoperatively, 3 times a day until post-operative day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| joint - pain scores and opiate consumption in Post Anesthesia Care Unit (PACU) | A joint outcome of average pain score and total opioid consumption between the end of surgery and the first two postoperative hours. Joint hypothesis testing will be used, meaning that Licorice gargling will be deemed better than sugar-water only if found noninferior on both opioid consumption and pain score and superior on at least one of the two. | first 2 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| joint - pain scores and opiate consumption on day of surgery | Postoperative pain intensity and opioid consumption between the end of surgery and the first postoperative morning. Joint hypothesis testing will be used, meaning that Licorice gargling will be deemed better than sugar-water only if found noninferior on both opioid consumption and pain score and superior on at least one of the two. | from end of surgery until the morning of Post-Operative Day (POD) 1 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Olga Plattner, M.D. | Medical University of Vienna | Study Chair |
| Marita Windpassinger, M.D. | Medical University Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MUVienna | Vienna | Austria |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
| ID | Term |
|---|---|
| C000722286 | Glycyrrhiza glabra extract |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sugar water | Other | Sugar gargle: Sirupus Simplex (sugar 5 g) diluted in 30cc water, gargle the solution for 60 seconds without swallowing it starting preoperatively, 3 times a day until post-operative day 3 |
|
| joint - pain scores and analgesic consumption | pain intensity and total analgesics (metamizole or mefenamic acid) consumption in the first three days after surgery. Joint hypothesis testing will be used, meaning that Licorice gargling will be deemed better than sugar-water only if found noninferior on both opioid consumption and pain score and superior on at least one of the two. | from surgery conclusion to Post-Operative Day (POD) 3 |
| postoperative coughing | incidence and intensity of postoperative coughing between surgery and the first two hours in the PACU | first 2 postoperative hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |