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

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

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

Study Overview

• Status: Completed
• Conditions: Thirst; Mouth Dryness; Irritation Lips
• Intervention / Treatment: Other: Mentholated lip moisturizer and ice popsicle; Other: Non-mentholated lip moisturizer and ice popsicle

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Paraná
    • Londrina, Paraná, Brazil, 86039-290
      • Viviane Moreira Serato

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Package of mentholated measures; Package of mentholated measures (mentholated Ice Popsicle and lip moisturizing) Group.	Other: Mentholated lip moisturizer and ice popsicle; Mentholated package of measures
Active Comparator: Package of non-mentholated measures; Package of non-mentholated measures (mentholated Ice Popsicle and lip moisturizing) Group.	Other: Non-mentholated lip moisturizer and ice popsicle; Non-mentholated package of measures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universidade Estadual de Londrina
• Investigators: Principal Investigator: Viviane Serato, Universidade Estadual de Londrina

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: August 8, 2016
• First Submitted That Met QC Criteria: August 11, 2016
• First Posted (Estimate): August 16, 2016

Study Record Updates

• Last Update Posted (Estimate): August 16, 2016
• Last Update Submitted That Met QC Criteria: August 11, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Thirst; Ice; Menthol; Perioperative Nursing.; Recovery Room
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: GPS Menthol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No