Licorice Versus Sugar-water Gargling for Pain in Patients Recovering From Ear-Nose-Throat and Maxilla-Facial Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Licorice Versus Sugar-water Gargling for Pain in Patients Recovering From Ear-Nose-Throat (ENT) and Maxilla-Facial Surgery - A Randomized, Double-blind Study

Conditions
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Pain, Postoperative, Surgery, Oral

Intervention / Treatment
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* Other: Licorice
* Other: Sugar water


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Oropharyngeal surgeries including:Panendoscopic surgery; elective tonsillectomy/adenotonsillectomy; demarcation and biopsy of suspected tongue carcinoma Anticipated extubation in the operating room American Society of Anesthesia physical status 1-3 Exclusion Criteria: Rapid Sequence Induction Known or suspected allergy to licorice or its ingredients Liver failure with bleeding disorders Insulin-dependent diabetes mellitus Use of non-steroidal anti-inflammatory drug medication within 24 hours before surgery Chronic opioid use Dementia or inability to use an iv Patient-Controlled-Analgesia (PCA) pump superinfected oropharyngeal tumors Planned postoperative mechanical ventilation or admission to Intensive Care Unit (ICU)

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Licorice<br>Licorice gargle | Other: Licorice<br>* 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<br>* Other names: Extractum Liquiritiae Fluidum;|
| Placebo Comparator: Sugar water<br>Sugar gargle | Other: Sugar water<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Pain, Anesthesia, Oral Surgery