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

NCT ID: NCT02968823

Last Updated: 2023-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2022-09-30

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.

Conditions

Pain, Postoperative; Surgery, Oral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Licorice

Licorice gargle

Group Type: ACTIVE_COMPARATOR

Licorice

Intervention Type: OTHER

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

Sugar water

Sugar gargle

Group Type: PLACEBO_COMPARATOR

Sugar water

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

Extractum Liquiritiae Fluidum

Eligibility Criteria

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)

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Olga Plattner

Ao. Univ. Prof., Head of ophthalmologic anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olga Plattner, M.D.

Role: STUDY_CHAIR

Medical University of Vienna

Marita Windpassinger, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University Vienna

Locations

MUVienna

Vienna, , Austria

Countries

Austria

Other Identifiers

1308/2016

Identifier Type: -

Identifier Source: org_study_id