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Completed

NCT Number: NCT02968823

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

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgery, Oral

Age range

12 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MUVienna

Vienna, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Licorice

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

Other names: Extractum Liquiritiae Fluidum

Sugar Water

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

Primary outcomes

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

    Time frame: first 2 postoperative hours

    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 outcomes

  1. joint - pain scores and opiate consumption on day of surgery

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

    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.

  2. joint - pain scores and analgesic consumption

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

    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.

  3. postoperative coughing

    Time frame: first 2 postoperative hours

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Collaborators

  • The Cleveland Clinic

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Nov 21, 2016
Registry last updated
Sep 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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