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

Not Applicable

Completed

• Conditions: Surgery, Oral; Pain, Postoperative
• Interventions: Other: Sugar water; Other: Licorice

• Registration Number: NCT02968823
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-16
• Study First Posted: 2016-11-21
• Study Start: 2017-07-01
• Primary Completion: 2022-09-30
• Study Completion: 2022-09-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 127

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

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sugar water	Sugar water	Sugar gargle
Licorice	Licorice	Licorice gargle

Primary Outcome Measures

Name	Time	Method
joint - pain scores and opiate consumption in Post Anesthesia Care Unit (PACU)	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 Outcome Measures

Name	Time	Method
joint - pain scores and opiate consumption on day of surgery	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.
joint - pain scores and analgesic consumption	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.
postoperative coughing	first 2 postoperative hours	incidence and intensity of postoperative coughing between surgery and the first two hours in the PACU

Trial Locations

Locations (1)

MUVienna; 🇦🇹 Vienna, Austria