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

NCT02968823 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2023-09-05

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Olga Plattner, M.D. · Medical University of Vienna

  • Marita Windpassinger, M.D. · Medical University Vienna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2022-09-30
Completion
2022-09-30

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02968823 on ClinicalTrials.gov