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

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02968823
• Other study ID #: 1308/2016
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: September 30, 2022

Study information

• Verified date: August 2023
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 127
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 99 Years

Eligibility

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:

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)

Related Conditions & MeSH terms

• Pain, Postoperative
• Surgery, Oral

Intervention

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
• 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

Locations

Country	Name	City	State
Austria	MUVienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	The Cleveland Clinic

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	from end of surgery until the morning of Post-Operative Day (POD) 1
Secondary	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.	from surgery conclusion to Post-Operative Day (POD) 3
Secondary	postoperative coughing	incidence and intensity of postoperative coughing between surgery and the first two hours in the PACU	first 2 postoperative hours