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

Medical University of Vienna127 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

127

Conditions

Pain, Postoperative Surgery, Oral

Interventions

Eligibility

Sex: ALLMin age: 12 YearsMax age: 99 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

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.

Time frame: first 2 postoperative hours

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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