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

Primary Purpose

Pain, Postoperative, Surgery, Oral

Status

Completed

Phase

Not Applicable

Locations

Austria

Study Type

Interventional

Intervention

Licorice

Sugar water

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Postoperative Pain, Anesthesia, Oral Surgery

Eligibility Criteria

12 Years - 99 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

MUVienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Licorice

Sugar water

Arm Description

Licorice gargle

Sugar gargle

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

postoperative coughing

incidence and intensity of postoperative coughing between surgery and the first two hours in the PACU

Full Information

NCT ID

NCT02968823

First Posted

November 14, 2016

Last Updated

August 30, 2023

Sponsor

Medical University of Vienna

Collaborators

The Cleveland Clinic

1. Study Identification

Unique Protocol Identification Number

NCT02968823

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

July 1, 2017 (Actual)

Primary Completion Date

September 30, 2022 (Actual)

Study Completion Date

September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Vienna

Collaborators

The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Postoperative, Surgery, Oral

Keywords

Postoperative Pain, Anesthesia, Oral Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

127 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Licorice

Arm Type

Active Comparator

Arm Description

Licorice gargle

Arm Title

Sugar water

Arm Type

Placebo Comparator

Arm Description

Sugar gargle

Intervention Type

Other

Intervention Name(s)

Licorice

Other Intervention Name(s)

Extractum Liquiritiae Fluidum

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Sugar water

Intervention Description

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

Primary Outcome Measure Information:

Title

joint - pain scores and opiate consumption in Post Anesthesia Care Unit (PACU)

Description

Time Frame

first 2 postoperative hours

Secondary Outcome Measure Information:

Title

joint - pain scores and opiate consumption on day of surgery

Description

Time Frame

from end of surgery until the morning of Post-Operative Day (POD) 1

Title

joint - pain scores and analgesic consumption

Description

Time Frame

from surgery conclusion to Post-Operative Day (POD) 3

Title

postoperative coughing

Description

incidence and intensity of postoperative coughing between surgery and the first two hours in the PACU

Time Frame

first 2 postoperative hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olga Plattner, M.D.

Organizational Affiliation

Medical University of Vienna

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Marita Windpassinger, M.D.

Organizational Affiliation

Medical University Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

MUVienna

City

Vienna

Country

Austria

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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