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

Medical University of Vienna

Status: Completed

Conditions: Pain, Postoperative; Surgery, Oral

Treatments: Other: Licorice; Other: Sugar water

Study type: Interventional

Funder types: Other

Identifiers

NCT02968823

1308/2016

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 12 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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127 participants in 2 patient groups, including a placebo group

Licorice

Active Comparator group

Description:

Licorice gargle

Treatment:

Other: Licorice

Sugar water

Placebo Comparator group

Description:

Sugar gargle

Treatment:

Other: Sugar water