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

NCT02968823 | Completed

• 1 other identifier: 1308/2016
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

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

Keywords

Postoperative Pain; Anesthesia; Oral Surgery

Outcome Measures

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.

  first 2 postoperative hours

Secondary Outcomes (3)

• joint - pain scores and opiate consumption on day of surgery

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

• joint - pain scores and analgesic consumption

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

• postoperative coughing

  first 2 postoperative hours

Study Arms (2)

Licorice

ACTIVE COMPARATOR

Licorice gargle

Other: Licorice

Sugar water

PLACEBO COMPARATOR

Sugar gargle

Other: Sugar water

Interventions

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

Also known as: Extractum Liquiritiae Fluidum

Licorice

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

Sugar water

Eligibility Criteria

• Age: 12 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Vienna: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

MUVienna

Vienna, Austria

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Glycyrrhiza glabra extract

Condition Hierarchy (Ancestors)

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

Study Officials

• Olga Plattner, M.D.

  Medical University of Vienna

  STUDY CHAIR

• Marita Windpassinger, M.D.

  Medical University Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ao. Univ. Prof., Head of ophthalmologic anesthesia

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 21, 2016
• Study Start: July 1, 2017
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2022
• Last Updated: September 5, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)