Effectiveness of Menthol Chewing Gum in the Management of Thirst

Thirst Clinical Trial

Official title:

Effectiveness of Menthol Chewing Gum in the Management of Preoperative Thirst: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03200197
• Other study ID #: Aline Korki Arrabal Garcia
• Status: Completed
• Phase: N/A
• First received: June 22, 2017
• Last updated: June 25, 2017
• Start date: November 2016
• Est. completion date: March 2017

Study information

• Verified date: June 2017
• Source: Universidade Estadual de Londrina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study was to compare the effectiveness of menthol chewing gum compared to maintained fasting (usual care) in reducing the intensity of the surgical patient's thirst during the preoperative period. The hypothesis of the study was that the use of menthol chewing gum in surgical patients in the preoperative period would be more effective than the maintenance of fasting with regard to the decrease in thirst and its discomforts.

Description:

There is evidence that chewing gum is effective in relieving thirst in the surgical patient in the preoperative period as it stimulates the salivary glands by means of mechano and chemoreceptors, increasing the salivary pH and flow, lubricating the oral cavity, acting in this way on peripheral thirst, which is triggered by dehydration of the oral mucosa. Furthermore, menthol gum stimulates the cold receptors, known as TRPM8, which are responsible for deactivating centers of thirst. Thus, the risk of bronchoaspiration due to gastric fullness is avoided and the discomfort of a dry mouth is reduced.Preliminary evidence indicates that the chewing gum strategy assists in the relief of a dry mouth and thirst in patients undergoing dialysis and head and neck radiotherapy. However, there is no scientific evidence of controlled studies with results that can be generalized regarding the use of chewing gum to reduce thirst and its discomforts in surgical patients in the preoperative period when they remain in a fasted state.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

Inclusion Criteria:

• Elective Surgeries;

• Aged between 12 and 65 years;

• Did not receive preanesthetic medication;

• Oriented in time and space;

• Present dentition (natural or artificial);

• Fasting for a minimum of three hours;

• Available for collection at least 3 hours prior to the scheduled surgical procedure;

• Verbalize thirst spontaneously or when questioned with an intensity greater than or equal to three on the Verbal Numerical Scale (VNS);

Exclusion Criteria:

• Allergy to menthol;

• Chewing restriction;

• Swallowing restriction;

• Patients who presented nausea, vomiting, or pain;

• Patients with chronic xerostomia;

• Chronic renal patients;

Related Conditions & MeSH terms

• Thirst

Intervention

Other:
• Menthol chewing gum
The experimental group received one unit of mentholated chewing gum, chewing and swallowing the saliva in a natural rhythm for 10 minutes. The menthol chewing gum used is called TRÍDENT®and is composed as follows: base gum, hydrogenated vegetable oil, vegetable oil, sweeteners: sorbitol, xylitol, mannitol, maltitol, aspartame, acesulfame potassium, and sucralose, humectants: glycerin and triacetin, flavorings (contains wheat derivatives), anti-humectant talc, emulsifiers: esters of mono- and diglycerides of fatty acids with acetic acid, soy lectin and mono and diglycerides of fatty acids and colorings: tartrazine and brilliant blue FCF, presenting a weight of 1.8g per unit.
• Usual care (fasting)
The control group received the usual care given at the hospitalization units, that is, when the patient reported thirst, the need to maintain fasting for 10 minutes was reaffirmed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual de Londrina

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intensity of thirst	Alteration in the evaluation of the final intensity of thirst in relation to the evaluation of the initial intensity of thirst [10 minutes]. For evaluation of the intensity of thirst, a Verbal Numeral Scale (VNS) was used, with a range from 0 (no thirst) to 10 (very intense thirst), as reported by the patients when questioned.	10 minutes
Secondary	discomfort of thirst	Alteration in the evaluation of the final discomfort of thirst in relation to the evaluation of the initial discomfort of thirst [10 minutes]. The Perioperative Thirst Discomfort Scale (PTDS) was used to evaluate the discomfort of the thirst.This scale is composed of 7 attributes that evaluate the signs of discomfort of perioperative thirst, as follows: dry mouth, dry lips, thick tongue, thick saliva, bad taste in the mouth, and desire to drink water. Each attribute varies between 0 (no inconvenience), 1 (a little inconvenient), and 2 (very inconvenient). The final sum of the PTDS can range from 0 to 14 points.	10 minutes