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CompletedNCT02968823Updated Sep 5, 2023

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

An interventional study of Licorice and Sugar water in Pain, Postoperative and Surgery, Oral, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 12 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-09-05.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
12 Years to 99 Years
Sex
All
01

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.

02

Conditions studied

  • Pain, Postoperative
  • Surgery, Oral

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Keywords

  • Postoperative Pain
  • Anesthesia
  • Oral Surgery
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 127 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
127 participants (actual)

Study arms

  • Active comparator
    Licorice

    Licorice gargle

    Other: Licorice

  • Placebo comparator
    Sugar water

    Sugar gargle

    Other: Sugar water

Interventions

  • OtherLicorice

    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

    Also known as: Extractum Liquiritiae Fluidum

  • OtherSugar 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

06

What researchers measure

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. postoperative coughing

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

    Time frame: first 2 postoperative hours

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Study locations

1 site
  • MUVienna
    Vienna, Austria
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02968823
Lead sponsor
Medical University of Vienna
Collaborators
The Cleveland Clinic
Responsible party
Olga Plattner (Ao. Univ. Prof., Head of ophthalmologic anesthesia, Medical University of Vienna) — Principal investigator
First posted
Nov 21, 2016
Start date
Jul 1, 2017
Primary completion
Sep 30, 2022
Completion
Sep 30, 2022
Last update
Sep 5, 2023

Study contacts

Olga Plattner, M.D.
study chair · Medical University of Vienna
Marita Windpassinger, M.D.
principal investigator · Medical University Vienna

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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