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

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

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 Overview

• Status: Completed
• Conditions: Pain, Postoperative; Surgery, Oral
• Intervention / Treatment: Other: Licorice; Other: Sugar water

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Olga Plattner, M.D.; Phone Number: 0043-1-40400-0; Email: olga.plattner@meduniwien.ac.at
• Study Contact Backup: Name: Marita Windpassinger, M.D.; Phone Number: 0043-1-40400-0; Email: marita.windpassinger@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria
    • MUVienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 99 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Licorice; Licorice gargle	Other: Licorice; 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; Other Names: Extractum Liquiritiae Fluidum
Placebo Comparator: Sugar water; Sugar gargle	Other: Sugar 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: The Cleveland Clinic
• Investigators: Study Chair: Olga Plattner, M.D., Medical University of Vienna; Principal Investigator: Marita Windpassinger, M.D., Medical University Vienna

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): September 30, 2022
• Study Completion (Actual): September 30, 2022

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: November 16, 2016
• First Posted (Estimated): November 21, 2016

Study Record Updates

• Last Update Posted (Actual): September 5, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Postoperative Pain; Anesthesia; Oral Surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 1308/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No