Package of Mentholated Measures for the Relief of Thirst in the Anesthesia Recovery Room

Thirst Clinical Trial

Official title:

Package of Mentholated Measures for the Relief of Thirst in the Anesthesia Recovery Room: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02869139
• Other study ID #: GPS Menthol
• Status: Completed
• Phase: N/A
• First received: August 8, 2016
• Last updated: August 11, 2016
• Start date: April 2014
• Est. completion date: January 2016

Study information

• Verified date: August 2016
• Source: Universidade Estadual de Londrina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Package of mentholated measures for the relief of thirst in the anesthesia recovery room: Randomized clinical trial

Description:

Perioperative thirst is intense and has a high incidence. There is evidence that strategies using cold and menthol could be viable alternatives to reduce thirst and the discomforts arising from it. For that reason, this study evaluated the efficacy of a mentholated package of measures (lip moisturizer and ice popsicle) compared to a non-mentholated package of measures in alleviating thirst in the anesthesia recovery room.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Possess aged between eighteen and sixty-five years

• To be fasting for more than four hours

• Verbalizing headquarters spontaneously or after questioning, with greater than or equal to three intensity in numerical verbal scale

• Receive opioids or anticholinergic during surgery duration of greater than one hour anesthesia

• Being in anesthetic recovery in anesthesia recovery room

• Have been approved in the evaluation Headquarter Insurance Management Protocol which was applied to both groups

• Accept participate and sign the consent form Clarified

Exclusion Criteria:

• Being allergic to menthol

• Have continuity of injury in the oral mucosa

• Having suspended the anesthetic-surgical procedure after acceptance of participation

• Receive High operating room directly to another healthcare sector than the anesthetic recovery room, and intensive care unit or hospital unit

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritation Lips
• Mouth Dryness
• Thirst
• Xerostomia

Intervention

Other:
• Mentholated lip moisturizer and ice popsicle
Mentholated package of measures
• Non-mentholated lip moisturizer and ice popsicle
Non-mentholated package of measures

Locations

Country	Name	City	State
Brazil	Viviane Moreira Serato	Londrina	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual de Londrina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in intensity of thirst, lip hydration, dryness of the mouth and taste the final oral cavity above the original between the experimental and control groups.	The evaluation procedures were repeated every 30 minutes for one hour, representing three evaluation moments (M1, M2 and M3).	three times: 0 minutes, 30 minutes and 60 minutes after intervention and evaluation	No
Secondary	Change in the extent of satiety point over an hour assessment, presented by experimental and control groups, and the number of interventions required in every moment of assessment and intervention for each group.	The evaluation procedures were repeated every 30 minutes for one hour, representing three evaluation moments (M1, M2 and M3).	three times: 0 minutes, 30 minutes and 60 minutes after intervention and evaluation	No