Ice Popsicle for Thirst Relief of the Surgical Patient

Thirst Clinical Trial

Official title:

Efficacy of Ice Popsicle in the Management of Thirst in the Immediate Postoperative Period: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149394
• Other study ID #: 16707313.5.0000.5231
• Status: Completed
• Phase: N/A
• First received: May 17, 2014
• Last updated: May 26, 2014
• Start date: August 2013
• Est. completion date: December 2013

Study information

• Verified date: May 2014
• Source: Universidade Estadual de Londrina
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the efficacy of ice popsicle compared with water at room temperature in relieving thirst in the immediate postoperative period . The hypothesis of the study is that ice has 20% greater efficacy than water to relieve thirst in the immediate postoperative period.

Description:

There is evidence that ice is effective in relieving thirst in surgical patients, because, by stimulating the oral receptors sensitive to cold, ice decreases the need to ingest large volumes of liquids to satisfy thirst. This way, the risk of bronchoaspiration due to gastric fullness is avoided and discomfort with dry mouth is reduced. Preliminary evidence, therefore, indicates that the use of ice chips have greater efficacy than water at room temperature in relieving thirst. However, there is no scientific evidence from controlled studies with results that can be generalized with respect to a safe volume and adequate frequency of ice administered to reduce thirst in the immediate postoperative period.Considering that the gold standard for the study of a symptom is based on individuals' perceptions and their reports, this study is justified in order to assess the effectiveness of ice compared with water at room temperature in relieving thirst in the immediate postoperative period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• aged between 18 and 65 years;

• undergoing more than eight-hour preoperative fasting;

• expressing thirst spontaneously or stimulated with intensity greater than or equal to three according to the numeric visual analogue scale;

• receiving opioids or anticholinergics during surgery;

• duration of anesthesia exceeding one hour;

• having been approved in the assessment by the Safety Protocol of Thirst Management;

• signing the informed consent during the preoperative period.

Exclusion Criteria:

• patients who had intake or swallowing restrictions.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Thirst

Intervention

Other:
• Ice popsicle
Patients were assessed according to the following criteria before each intervention: level of awareness; airway protection capacity; and absence of nausea and vomiting, according to the Safety Protocol for Thirst Management. The experimental group received an ice popsicle made of 10 mL mineral water. The ice popsicles were made according to the predetermined volumes and packed in the freezer of the anesthetic recovery room at the institution researched. The block of ice were supported by a stick, allowing the patients to control the intensity of cold conferred by the ice for their comfort.
• Water at room temperature
Patients were assessed according to the following criteria before each intervention: level of awareness; airway protection capacity; and absence of nausea and vomiting, according to the Safety Protocol for Thirst Management. The usual activities adopted by the nursing staff of the anesthetic recovery room were maintained for the control group that received 10 mL mineral water at room temperature in a syringe.

Locations

Country	Name	City	State
Brazil	University hospital - State University of Londrina	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 the intensity of the final thirst assessment with respect to the initial thirst assessment.	5 evaluations of thirst intensity every 15 minutes during the first hour postoperatively.; Thirst intensity was measured within the range from 1 to 10 in 1.0 intervals as reported by patients when orally required "how thirsty are you now?"according to the visual analogue scale. Zero means not thirsty at all and ten the worst thirst sensation that the patient have ever had.	1 hour	No
Secondary	Reaching the point of satiety over one-hour assessment presented by the experimental and control groups.	5 evaluations of thirst intensity and satiety every 15 minutes during the first hour postoperatively. Thirst intensity was measured within the range from 1 to 10 in 1.0 intervals as reported by patients when orally required "how thirsty are you now?"according to the visual analogue scale. Zero means not thirsty at all and ten the worst thirst sensation that the patient have ever had.according to the visual analogue scale. Satiety was characterized as intensity of thirst = zero (0).	1 hour	No