Pain, Postoperative, Surgery, Oral
Conditions
Keywords
Postoperative Pain, Anesthesia, Oral Surgery
Brief summary
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.
Interventions
OTHERLicorice
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
OTHERSugar water
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
Sponsors
The Cleveland Clinic
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Oropharyngeal surgeries including:Panendoscopic surgery; elective tonsillectomy/adenotonsillectomy; demarcation and biopsy of suspected tongue carcinoma 2. Anticipated extubation in the operating room 3. American Society of Anesthesia physical status 1-3
Exclusion criteria
1. Rapid Sequence Induction 2. Known or suspected allergy to licorice or its ingredients 3. Liver failure with bleeding disorders 4. Insulin-dependent diabetes mellitus 5. Use of non-steroidal anti-inflammatory drug medication within 24 hours before surgery 6. Chronic opioid use 7. Dementia or inability to use an iv Patient-Controlled-Analgesia (PCA) pump 8. superinfected oropharyngeal tumors 9. Planned postoperative mechanical ventilation or admission to Intensive Care Unit (ICU)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| joint - pain scores and opiate consumption in Post Anesthesia Care Unit (PACU) | first 2 postoperative hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| joint - pain scores and opiate consumption on day of surgery | from end of surgery until the morning of Post-Operative Day (POD) 1 | 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. |
| joint - pain scores and analgesic consumption | from surgery conclusion to Post-Operative Day (POD) 3 | 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. |
| postoperative coughing | first 2 postoperative hours | incidence and intensity of postoperative coughing between surgery and the first two hours in the PACU |
Countries
Austria
Outcome results
None listed