Clinical trial NCT02149394: Ice Popsicle for Thirst Relief of the Surgical Patient
Official title: Efficacy of Ice Popsicle in the Management of Thirst in the Immediate Postoperative Period: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thirst
Keywords: Thirst
Ice
Water
Perioperative Nursing
Recovery Room
Lead sponsor: Universidade Estadual de Londrina
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the intensity of the final thirst assessment with respect to the initial thirst assessment.
timeFrame: 1 hour
Secondary outcomes:
measure: Reaching the point of satiety over one-hour assessment presented by the experimental and control groups.
timeFrame: 1 hour
Other outcomes:
Locations:
city: Londrina
country: Brazil
facility: University hospital - State University of Londrina
state: Paraná
Study officials:
affiliation: Universidade Estadual de Londrina
name: Marilia F Conchon
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Estadual de Londrina
name: Ligia F Fonseca, PhD
role: STUDY_DIRECTOR
References: