Elaboration, validation and reliability of the safety protocol for pediatric thirst management

Objective: to elaborate, validate and evaluate the reliability of the Safety Protocol for Pediatric Thirst Management in the immediate postoperative period. Method: methodological quantitative research, based on the assumptions on measurement instrument development. The protocol was elaborated after literature review, interview with specialists and observation of the child’s anesthetic recovery. The judges performed theoretical validation through apparent, semantic and content analysis. Content Validity Index was calculated for content validation, whose minimum established concordance was 0.80. Protocol’s reliability was evaluated in children between three and 12 years old in the Post Anesthesia Care Unit. Results: in its final version, the protocol consisted of five evaluation criteria: level of consciousness, movement, airway protection, breathing pattern and nausea and vomiting. It presented easy comprehension and relevant content, and all indexes exceeded the minimum agreement of 0.80. Pairs of nurses applied the protocol 116 times to 58 children, resulting in a high reliability index (kappa general = 0.98) Conclusion: the unprecedented protocol developed is valid and is a useful tool for use in anesthetic recovery, aiming to assess safety for reducing the thirst of infant patients.

Fasting is extended to the immediate postoperative period (IPP) and fluids are usually released in the first three hours for most children (7) . However, a clinical trial revealed that fluid intake even more precociously in the Post Anesthesia Care Unit (PACU) did not increase the incidence of nausea and vomiting (8) . The benefits of early fluid release in the IPP are: More parental satisfaction, happier and less uncomfortable children with pain, reduced use of medication for nausea, reduced length of stay in PACU, and reduced thirst (8)(9)(10) .
Anesthetic recovery is characterized by the return of consciousness and during awakening, the child may experience pain, being confused and agitation. Thirst also influences the child's mode of awakening and recovering from anesthesia, being one of the factors responsible for the anguish they experience in this period (8)(9)(11)(12)(13) .
The surgical child is at high risk for developing thirst due to hydroelectrolytic imbalance, endotracheal intubation, use of medications, among others (14)(15)(16) . The nursing team working in the PACU therefore needs to consider thirst as an object of care intentionally, identifying, measuring, assessing safety and using effective strategies to reduce the child's thirst (17) . The team, however, usually feels insecure to treat thirst (18) in the anesthetic recovery phase, as it does not have systematic instruments that assess safety to offer a method of relieving pediatric thirst, prolonging the suffering of the child and his family (9,19) .
To support the team in the decision to use a thirst relief strategy, the Safety Protocol for Thirst Management (SPTM) of adult patients in PACU was elaborated (20) . The team has also used this instrument for the infant patient, even without proving that the proposed evaluation criteria for the adult are also relevant for the child.
The instrument validation process is essential for the results to be significant, reliable, precise and accurate (21) . Validity and reliability are the main aspects in the process. Validity verifies whether the instrument measures exactly what it proposes to measure and reliability represents the degree of coherence with which the instrument measures the attribute (22) .
The need to develop and validate a safety protocol for the management of thirst in children in the IPP is justified by its high prevalence and intensity (1,23) .
In addition, no instrument was found to support the practice of PACU professionals in the assessment of adequate criteria that allow the effective use of effective strategies to relieve the child's thirst in this period. The objective of this study was, therefore, to elaborate, validate and evaluate the reliability of the Safety Protocol for Pediatric Thirst Management (SPPTM) in the IPP.

Method
Methodological, quantitative research, carried out between July 2017 and April 2018. In view of the difficulty in finding specific methodologies for the elaboration of protocols that presuppose decisionmaking for care and aiming to follow a rigorous methodological process, an adaptation of the steps of the Pasquali model was used (24) . This model is based on psychometry that measures subjective phenomena and was used by another protocol validation study as a guide to its steps (20) . This model consists of three procedurestheoretical, experimental and analytical (24) , whose steps are summarized in Figure 1.
In the theoretical procedures stage, it is recommended to search the literature, clustering the knowledge of specialists and observation extracted from practical experience (24) . The psychological system was defined as safety for pediatric thirst management in the immediate postoperative period, and assessment criteria as the property of the psychological system (attributes), whose evaluation is the object of this were also examined (25)(26)(27) .   Subsequently, the behavioral representation of the constructs was established (24) and the actions that the nurse must take to assess safety for the management of thirst were defined . Finally, the operational manual was prepared, which presents the theoretical basis of the protocol.
Theoretical analysis was performed by specialists through the apparent validation (22) , semantic analysis and content validation (24)  asked to reproduce their understanding on the exposed content.

The content validation took place in November and
December 2017 through the Delphi Technic (28) . Thirteen professionals were invited, two did not accept to participate and two did not return the instruments in the appointed period. Therefore, nine judges participated, including nurses (n = five), anesthesiologists (n = three) and a speech therapist (n = one). There was a concern to include judges from different academic  The analytical procedures consisted of assessing the protocol's reliability by inter-rater agreement. The kappa coefficient was used to estimate the agreement among the evaluators, calculated by the ratio of the proportion of times the observers agreed (corrected by agreement due to chance) to the maximum proportion of times they could agree (32) .  (33) . and mental disorders, as they might not be able to express the necessary answers for the assessment.
The minimum age for inclusion was three years old, because, from then on, the child is able to speak his own name, name objects, show ability to move, has more precise movements and can handle objects (34) .

Results
In the literature search, a specific evaluation scale was found when the child awakens from sedation and regains consciousness, with the following items: eye response, appearance and function, and body movement (35) . Regarding the main complications in the IPP, pain, nausea, vomiting and emergency delirium (ED) stand out. It is a common condition in children in the IPP, defined as a disturbance in the child's awareness and attention to his environment, with disorientation and perceptual changes (12) , with the presence of restlessness, crying, moaning or irritating speech and screams (36) . Few evaluation criteria were found for early fluid release: Spontaneous verbalization of the child (8)(9) , appears to be awake enough (8) and receive a score that is greater than or equal to four (9)  A single round of content evaluation by the experts was sufficient to overcome the minimum agreement of 0.80 (24,30) . Table 1 shows the CVI values of the evaluation criteria and their representative items.         Pierotti I, Fonseca LF, Nascimento LA, Rossetto EG, Furuya RK. Head firm and aligned to the torso 100 1 Do not move the limbs 100 1 Unintentional movement 100 1 Head hanging and/or lateralized 100 1

Airway Protection
Effective and spontaneous cough 100 1 Ineffective cough 100 1 Has no cough 100 1 Ineffective swallowing 100 1 There is no abnormal spillage of saliva 100 1 Ineffective swallowing 100 1 There is no abnormal spillage of saliva 100 1

Nausea and Vomiting
There is no complaint or presence of nausea 100 1 There is complaint or presence of nausea 100 1 There is no complaint or presence of vomiting 100 1 There is complaint or presence of vomiting 100 1 Kappa total † 0.98  Table 3 shows the values of kappa calculated for each SPPTM evaluation item, with almost perfect agreement for all items (33) .

Discussion
The contribution of this study consists of making available an unprecedented, judicious, objective, valid and accurate instrument that allows assessing safety to manage strategies for relieving thirst for infant patients in the IPP. For the elaboration, validation and evaluation of the protocol's reliability, high scientific rigor followed (24) .
The interviews with specialists made it possible to observe how diverse and subjective the criteria used by the professionals responsible for authorizing methods to relieve thirst in the IPP are. Professionals reported that, most of the time, they look at the child in the PACU and assess whether, apparently, they are awake enough and without complaints, then they allow the intake of liquid orally. However, this assessment is not standardized or based on criteria and varies according to the determination of "being well awake" by each professional. It was also observed that, when liquid intake is authorized, there is no consensus as to the type and volume to offer. There were reports on the limitation of specific literature for the child, resulting in adapted evaluations, which consider criteria of adult patients.
Currently, the anesthesiologist is responsible for the authorization for liquid oral ingest in the PACU, which explains the greater number of them in the interview stage.
The "level of consciousness" criterion was one of the most frequently suggested by professionals, considered an essential item to determine the emergence of the anesthetic state during the IPP. When asked about the scales used to assess children's awareness, the answers were varied: Glasgow comma scale (37) , Comfort-Behavior (38) , Index Steward (39) scale of Aldrete and Kroulik (40) . However, the Glasgow and Comfort-B scales do not apply to children in the IPP, because they assess the level of sedation and have been validated for children in the intensive care unit. The Steward Index (39) and the Rev. Latino-Am. Enfermagem 2020;28:e3321.
scale of Aldrete and Kroulik (40) , although targeted at patients in the PACU, may not be adequate to be used with a child (35) .
A scale for assessing the child's consciousness after sedation was found in the literature (35) . This is  (12) .
Therefore, for selecting the items for evaluating the SPPTM awareness level criterion, the presence of these behaviors was considered.
When evaluating the item "is oriented" in the behavioral requirement, some experts indicated that children aged between three and five years could possibly not answer their name and age because they are in an unknown environment and regaining consciousness. There was no such difficulty during the application of the protocol in practice. However, this study employed a convenience sample, and a larger number of this population would be needed to assess this issue in depth.
It is more difficult to assess the child's level of consciousness than that of the adult, and it is challenging to identify the child's inability to communicate (35) .
When assessing reliability, the evaluators disagreed on the items "is alert" and "is sleepy", confirming the difficulty and subjectivity in assessing the child's level of consciousness. The need for a period of interaction with the child was identified before starting up the assessment.
Two judges considered the criterion "movement" as not relevant in measuring safety for the thirst management. For others (n=three), it represents an evaluation criterion complementary to the level of consciousness, measured by the ability to perform intentional movements and keep the head firm and aligned with the trunk. Additionally, the presence of voluntary and purposeful movements is part of the scales for assessing the child's consciousness (12,35) , justifying the choice to keep this item in the protocol.
In addition, the ability to move with intentionality may indicate reversal of general inhaled anesthetics and neuromuscular blockers.
The evaluation of criterion "airway protection" ensures the verification of the return of protective cough and swallowing reflexes. These reflexes indicate that the patient is able to defend himself against a possible bronchopulmonary aspiration (41) . The incidence of perioperative pulmonary aspiration in pediatric patients varies from one to ten in 10,000. Additionally, when there is a consequence, it is considered mild and, to date, there have been no reports of mortality from pulmonary aspiration in children (4) . Evaluating the protective reflexes in the SPPTM presupposes the evaluation of cough and swallowing.
Two experts pointed out in the content validation that the assessment of protective reflexes (coughing and swallowing) could encounter some difficulty with younger children. However, they considered this item as of extreme relevance in order to determine the safety for oral liquid release in the IPP. Therefore, a prior approach to the child is recommended, in order to reduce the anxiety and fear present in this period, so that there is a bond and trust in the moment of assessment.
During interviews with specialists, it was mentioned that crying could be considered a protective reflex, indicating that the child's airway would be free. But crying can represent several situations, such as pain, discomfort, irritation, agitation and ED. Differentiating their presence is difficult and subjective, therefore, in the protocol, the presence of crying characterizes the child's failure to receive a method of relieving thirst.
The "breathing pattern" consists of the assessment of respiratory frequency and respiratory effort, when signs of accessory muscle contraction, intercostal, subcostal and wishbone retraction, and nose wing beats must be absent (42) . For some professionals, the evaluation of this criterion signals the main changes in the child's clinical status. Furthermore, adverse perioperative respiratory events represent one of the main reasons for morbidity and mortality in children (43) .
The absence of "nausea and vomiting" is paramount for administering methods for relieving thirst. The presence of vomiting is still a complication feared by the team due to the possibility of subsequent Pierotti I, Fonseca LF, Nascimento LA, Rossetto EG, Furuya RK.
pulmonary aspiration, although recently, its incidence is between 25% and 30% in children undergoing general anesthesia (44) . The absence of these complications indicates reversion of anesthetic agents.
Clinical trials have evaluated whether postoperative fasting would reduce the incidence of nausea and vomiting in children. One study found no statistically significant difference between the two groups observed, with incidence of 15% in the liberal group and 22% in the fasting group (p = 0.39) (8) . Another study revealed an association between early postoperative oral fluid intake and a reduction in the incidence of vomiting, which was 11.4% in the liberal group and 23.9% in the fasting group (9) . In both studies cited, the child's willingness to receive liquid and food was considered. When the child is forced to drink fluid early, there is increased vomiting incidence (45) . The experts considered the child's willingness to drink and the child's verbalization as relevant evaluation criteria. Therefore, when questioning the presence of thirst in the child, it is also necessary to question his willingness to receive any strategy to relieve thirst and only then begin the SPPTM assessment.
The application of SPPTM by nurses showed a high overall value of the kappa coefficient. This means that this instrument has inter-rater agreement, indicating that it can be reproduced in other realities. Thus, there is an indication that this instrument is a useful tool for the nursing care in the PACU, minimizing the presence of a prevalent and intense symptom such as thirst, especially for the infant patients.
One of the obstacles encountered in conducting this study was the scarcity of instruments to assess the child's anesthetic recovery, resulting in the difficulty of structuring the criteria to direct the child's assessment in this period in relation to the release of liquid orally by the professionals. This study, therefore, has come to fill a gap in the literature and to subsidize the care provided to the surgical child with thirst.
Assessing safety for thirst management, using relevant selected criteria, allows nurses to look intentionally at a frequent symptom and to safely intervene safely in its management. It is noteworthy that the protocol was designed for children who do not have communication limitations and children without contraindications to receiving oral fluids in the IPP.
The limitation of this study was centered on the convenience sample. It is suggested, therefore, that the protocol be applied to a larger number of children, in other institutions and with stratification by age. Further studies are needed to assess factors associated with approval of the protocol, as well as the most suitable moments for its use in the child's anesthetic recovery.
Even so, the reliability values of the SPPTM were high, indicating the accuracy of this instrument.

Conclusion
The When evaluating the reliability of the protocol in its practical application with surgical children aged between 3 and 12 years in the IPP, it was possible to observe an almost perfect agreement between the evaluators.
The SPPTM is, therefore, a valid and accurate instrument, indicating that it is a useful tool for use in clinical practice in the PACU, enabling the safe management of pediatric thirst.