Pain, PostoperativeNCT02968823
Licorice Versus Sugar-water Gargling for Pain in Patients Recovering From Ear-Nose-Throat and Maxilla-Facial Surgery
A study testing Licorice and Sugar water in people with Pain, Postoperative and Surgery, Oral, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 99 years
- Conditions the study is for
- Pain, Postoperative, Surgery, Oral
- What is being tested?
- Licorice and Sugar water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2017to 30 Sep 2022
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Licorice, Sugar water
- Keywords
- Postoperative Pain, Anesthesia, Oral Surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LicoriceOther
Also called Extractum Liquiritiae Fluidum
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 waterOther
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
| Study group | Role | What they receive |
|---|---|---|
| Licorice | Active comparator | Licorice gargle Receives: Other: Licorice |
| Sugar water | Placebo comparator | Sugar gargle Receives: Other: Sugar water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: first 2 postoperative hours
Secondary outcomes (3)
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.
Measured: from end of surgery until the morning of Post-Operative Day (POD) 1
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.
Measured: from surgery conclusion to Post-Operative Day (POD) 3
postoperative coughing
incidence and intensity of postoperative coughing between surgery and the first two hours in the PACU
Measured: first 2 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study start1 Jul 2017
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- The Cleveland Clinic
- Responsible party
- Principal investigator, Olga Plattner, Medical University of Vienna
- Investigators
- Olga Plattner, M.D., Study chair, Medical University of ViennaMarita Windpassinger, M.D., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968823
- Sponsor's protocol ID
- 1308/2016
- Status last verified
- Aug 2023
- First submitted
- 14 Nov 2016
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No