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Preschool children are at high risk for preoperative anxiety.
•
Tablet is equally effective at reducing preoperative anxiety compared to midazolam.
•
Active distraction resulted in shorter length of stay.
•
Parents prefer their children have less medicine preoperatively.
Abstract
Purpose
The primary purpose of this study was to compare the effect of active distraction to midazolam as a non-pharmacological method of reducing preoperative anxiety in preschool children. A secondary purpose was to compare emergence delirium, sedation/agitation, and length of stay between groups.
Design and methods
Preschool children (N = 99) scheduled for elective surgery participated in this 2-group randomized controlled trial: the active distraction (tablet) group (n = 52) had unlimited playtime with a tablet and the midazolam group (n = 47) were medicated approximately 10 min before mask induced anesthesia. Data were collected using the modified Yale Preoperative Anxiety Scale, Pediatric Anesthesia Emergence Delirium scale, and Richmond Agitation Sedation Score. Length of stay (LOS) was measured in minutes from PACU admission to discharge. Wilcoxon rank sum, Pearson's chi square, and Fischer's exact tests were used in analysis.
Results
Preschool children (3–5 years old), predominantly male (61%) and White (85%) presented for ear, nose, throat, ophthalmology, urology, and general surgery at a pediatric surgical center within a large Midwestern hospital. There was no significant difference in anxiety, emergence delirium, or sedation/agitation scores between midazolam and tablet groups. Children assigned to the tablet group had shorter LOS (p = 0.021).
Conclusion
Active distraction with a tablet as an anxiolytic was as effective as midazolam for pre-school aged children with no side effects and reduced length of stay.
Practice implications
Preoperatively, non-pharmacological methods such as active distraction with a tablet should be considered for preschool children as an alternative to medication.
). In addition, preoperative anxiety may cause a neuroendocrine response presenting as maladaptive behaviors that can impact the initial postoperative recovery period and may persist for up to 6 months or longer (
Causes of preoperative anxiety in preschool children include the unfamiliar preoperative environment, encounters with doctors and nurses, wearing a hospital gown, obtaining vital signs, being weighed, or simply placing a name band on their wrist. To minimize preoperative anxiety many approaches, both pharmacologic and non-pharmacologic, have been implemented. Midazolam, a pharmacologic agent, is commonly used as an anxiolytic in the pediatric population (
Children and parental anxiolysis in paediatric ambulatory surgery: A randomized controlled study comparing 0.3 mg kg− 1 midazolam to tablet computer based interactive distraction.
Tablet-based interactive distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: A noninferiority randomized trial.
Single-blinded randomized controlled study on use of interactive distraction versus oral midazolam to reduce pediatric preoperative anxiety, emergence delirium, and postanesthesia length of stay.
Journal of Perianesthesia Nursing.2019; 34: 567-575
). When exploring the effectiveness of distraction as an anxiolytic, the studies reviewed consisted of children from toddlerhood through adolescence; no studies focused on children from only one specific developmental stage, such as preschool. Since children respond differently than adults, and younger children are developmentally different from older children, previous studies should not be generalized to younger children. Thus, our study sought to determine the effectiveness of using tablets as a preoperative anxiolytic in preschool children ages 3 to 5.
). Analgesics are typically given to treat these side effects, which can result in nausea, vomiting, and drowsiness. Non-pharmacologic anxiolytic interventions may be beneficial to control anxiety and minimize the side effects of medications.
In nine randomized controlled trials, researchers explored differences in anxiety between children who received non-pharmacologic distraction compared to those who received a pharmacologic intervention (
Play distraction versus pharmacological treatment to reduce anxiety levels in children undergoing day surgery: A randomized controlled non-inferiority trial.
Child: Care, Health and Development.2016; 42: 572-581
Children and parental anxiolysis in paediatric ambulatory surgery: A randomized controlled study comparing 0.3 mg kg− 1 midazolam to tablet computer based interactive distraction.
Tablet-based interactive distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: A noninferiority randomized trial.
Single-blinded randomized controlled study on use of interactive distraction versus oral midazolam to reduce pediatric preoperative anxiety, emergence delirium, and postanesthesia length of stay.
Journal of Perianesthesia Nursing.2019; 34: 567-575
Children and parental anxiolysis in paediatric ambulatory surgery: A randomized controlled study comparing 0.3 mg kg− 1 midazolam to tablet computer based interactive distraction.
Tablet-based interactive distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: A noninferiority randomized trial.
Single-blinded randomized controlled study on use of interactive distraction versus oral midazolam to reduce pediatric preoperative anxiety, emergence delirium, and postanesthesia length of stay.
Journal of Perianesthesia Nursing.2019; 34: 567-575
Play distraction versus pharmacological treatment to reduce anxiety levels in children undergoing day surgery: A randomized controlled non-inferiority trial.
Child: Care, Health and Development.2016; 42: 572-581
Play distraction versus pharmacological treatment to reduce anxiety levels in children undergoing day surgery: A randomized controlled non-inferiority trial.
Child: Care, Health and Development.2016; 42: 572-581
Children and parental anxiolysis in paediatric ambulatory surgery: A randomized controlled study comparing 0.3 mg kg− 1 midazolam to tablet computer based interactive distraction.
Tablet-based interactive distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: A noninferiority randomized trial.
Single-blinded randomized controlled study on use of interactive distraction versus oral midazolam to reduce pediatric preoperative anxiety, emergence delirium, and postanesthesia length of stay.
Journal of Perianesthesia Nursing.2019; 34: 567-575
Tablet-based interactive distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: A noninferiority randomized trial.
Single-blinded randomized controlled study on use of interactive distraction versus oral midazolam to reduce pediatric preoperative anxiety, emergence delirium, and postanesthesia length of stay.
Journal of Perianesthesia Nursing.2019; 34: 567-575
Children and parental anxiolysis in paediatric ambulatory surgery: A randomized controlled study comparing 0.3 mg kg− 1 midazolam to tablet computer based interactive distraction.
Play distraction versus pharmacological treatment to reduce anxiety levels in children undergoing day surgery: A randomized controlled non-inferiority trial.
Child: Care, Health and Development.2016; 42: 572-581
compared active and passive distraction with midazolam and found no differences.
All studies reviewed assessed anxiety using the modified Yale Preoperative Anxiety Scale (mYPAS). The mYPAS is a valid/reliable observational tool used to evaluate patients' anxiety preoperative and during induction of anesthesia (
). Differences in findings specific to anxiety may be attributed to the timing of the measurement. Most researchers measured anxiety at the time of mask induction of anesthesia (
Play distraction versus pharmacological treatment to reduce anxiety levels in children undergoing day surgery: A randomized controlled non-inferiority trial.
Child: Care, Health and Development.2016; 42: 572-581
Children and parental anxiolysis in paediatric ambulatory surgery: A randomized controlled study comparing 0.3 mg kg− 1 midazolam to tablet computer based interactive distraction.
Tablet-based interactive distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: A noninferiority randomized trial.
Single-blinded randomized controlled study on use of interactive distraction versus oral midazolam to reduce pediatric preoperative anxiety, emergence delirium, and postanesthesia length of stay.
Journal of Perianesthesia Nursing.2019; 34: 567-575
Sample characteristics, age, and duration of the non-pharmacologic interventions varied from study to study. The studies reviewed included children across a variety of developmental stages.
Tablet-based interactive distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: A noninferiority randomized trial.
was the only study to report changes in mYPAS score by age (4–5, 6–9, >10), yet there were no significant differences between groups for any age subgroup, possibly due to small sample sizes. Since children may respond differently to stressful situations and interventions (pharmacologic and non-pharmacologic), based on their age and developmental stage, it is unclear if distraction as an intervention would be appropriate, feasible, or beneficial for preschool children.
In the studies reviewed, duration of intervention (playtime) varied from 1 min to 60 min, with one study not reporting the intervention duration (
). None of the studies allowed children unlimited playtime nor controlled for variations in timing of the intervention. Thus it remains unknown if duration of playtime had any influence on children's preoperative anxiety. It was also unclear how duration of playtime was defined and whether the timing of the intervention continued during transfer to the OR and mask induction of anesthesia. Therefore, comparison of intervention duration between studies were difficult.
Pharmacologic management of anxiety in children
Midazolam, a benzodiazepine with anxiolytic and amnesic properties, is routinely given to children to manage anxiety (
). Administering medication to uncooperative pediatric patients is both challenging and stressful. As with most pharmaceutical agents, midazolam is not without side effects. The most serious side effects of midazolam include respiratory depression, excess sedation, hypotension, paradoxical reaction, emergence delirium (ED), and agitation (
). Although administration of midazolam is common practice, exploring non-pharmacologic interventions that do not have serious side effects warrants attention.
Emergence delirium
Emergence delirium (ED) is a condition occurring post general anesthesia, characterized by hallucinations, delusions, and confusion. Children with ED exhibit restlessness, screaming, and involuntary thrashing in bed and are therefore at risk for disrupting surgical wounds, dislodging medical equipment, and causing injury to themselves or others (
). Not only is it difficult for nurses to manage ED in children, but it is also distressing for parents to witness. It has been noted that preschool children experience higher rates of ED when compared to older children (
). The higher incidence of ED in preschool children is most notable following surgeries involving ear, nose and throat, ophthalmology, and circumcisions (
found children who received midazolam preoperatively experienced a higher incidence of ED compared to children who did not receive the medication. This is consistent with the evidence that lists ED as a side effect of midazolam (
Strategies to prevent ED remain controversial, but rapid identification of ED is imperative to reduce injury and lessen associated ill effects. Emergence delirium in the pediatric population is typically assessed with the Pediatric Anesthesia Emergence Delirium (PAED) scale (
Tablet-based interactive distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: A noninferiority randomized trial.
Single-blinded randomized controlled study on use of interactive distraction versus oral midazolam to reduce pediatric preoperative anxiety, emergence delirium, and postanesthesia length of stay.
Journal of Perianesthesia Nursing.2019; 34: 567-575
measured the incidence of ED. None of these studies found a significant difference between the non-pharmacologic intervention and midazolam during “emergence from anesthesia” post-surgery. However,
Single-blinded randomized controlled study on use of interactive distraction versus oral midazolam to reduce pediatric preoperative anxiety, emergence delirium, and postanesthesia length of stay.
Journal of Perianesthesia Nursing.2019; 34: 567-575
found a significant difference at 15 min post-emergence from anesthesia, with less ED in the non-pharmacologic group compared to the midazolam group (p = 0.001). Conflicting findings may be attributed to variations in the timing of the assessment.
Sedation/agitation
The sedative and anxiolytic properties of midazolam are beneficial, as it increases cooperation during mask induction (
). A rare unintended side effect occurs when children experience a paradoxical reaction in which children become delirious and combative, requiring medication reversal to prevent injury (
Single-blinded randomized controlled study on use of interactive distraction versus oral midazolam to reduce pediatric preoperative anxiety, emergence delirium, and postanesthesia length of stay.
Journal of Perianesthesia Nursing.2019; 34: 567-575
). None of the studies reviewed measured sedation or agitation, and it is unknown if either pharmacologic or non-pharmacologic interventions influence sedation and agitation postoperatively.
Length of stay
Research findings on LOS and midazolam are conflicting (
). Length of stay may or may not be associated with medications administered during the perianesthesia period. LOS was only addressed in two of the studies we reviewed.
Tablet-based interactive distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: A noninferiority randomized trial.
Single-blinded randomized controlled study on use of interactive distraction versus oral midazolam to reduce pediatric preoperative anxiety, emergence delirium, and postanesthesia length of stay.
Journal of Perianesthesia Nursing.2019; 34: 567-575
reported that LOS was shorter in the non-pharmacologic group compared to the pharmacologic group.
Preschool development
Characterized by Erikson's psychosocial stage of initiative versus guilt, preschool children benefit from asserting control and exploring the world around them to create a sense of accomplishment and mastery (
). Children in this age group like to participate in activities with purpose. Thus, based on their developmental abilities, using an interactive tablet-like device with age-appropriate games might be useful as an alternative to pharmacologic interventions.
Purpose
The primary purpose of this study was to compare tablet-based active distraction versus midazolam as a method of managing preoperative anxiety in preschool children ages 3 to 5. The secondary purpose was to compare the two groups on the frequency of side effects of ED, frequency of sedation and agitation, and the difference in length of stay (Fig. 1).
The study design and research questions are based upon the conceptual model found in Fig. 1. In this model, we posit no difference in anxiolytic effects between pharmacological and non-pharmacologic interventions. However, pharmacologic interventions have side effects, such as sedation and agitation, which will impact length of stay.
Methods
Design
A 2-group randomized controlled clinical trial was used to address the specific aims of the study. Data were collected from April 2017 to March 2019.
Specific aims
In this study of preschool children ages 3 to 5 who received the tablet versus those who received oral midazolam, we sought to compare preoperative anxiety scores as measured by the mYPAS; postoperatively compare the frequency of ED, as measured by the PAED; preoperative and postoperatively compare the presence of sedation and agitation, as measured by the RASS; and compare Post Anesthesia Care Unit (PACU) length of stay, as measured in minutes (Table 2).
To achieve a moderate effect, the desired sample for this study was 36 per group with an alpha of 0.05 and power of 0.80. Oversampling was used to accommodate for possible attrition.
This study was conducted in a 10-bed pediatric PACU at a large Magnet® designated quaternary care medical center in Midwest USA. Preschool children ages 3 to 5 scheduled for elective surgery under general anesthesia with mask induction were included in the study. Anesthesia providers classify children according to the American Society of Anesthesiologists (ASA), which is a subjective grading system to rate a patient's preoperative comorbidity. Children were included in the study if classified as ASA I or II (Table 3).
Table 3American Society of Anesthesiologists physical status classification system:
ASA classification
Description
I
Healthy
II
Mild systemic disease; has a controlled disease of one body system
III
Severe systemic disease; has a controlled disease of more than one body system or major system
IV
Severe systemic disease that is constant threat to life; or severe disease that is poorly controlled or end stage
V
Patient with catastrophic injuries not expected to survive without an operation
VI
Brain death
Committee on Economics. (2020, December 13). ASA Physical Status Classification System. American Society of Anesthesiologists.
Excluded from this study were children with ASA classification of III or higher, children with an allergy to midazolam, or children with documented cognitive and developmental delays. In addition, children were excluded if the anesthesiologist determined it would be in the child's best interest to be pre-medicated with midazolam prior to surgery.
Recruitment procedures
Researchers regularly reviewed the surgery schedule to identify eligible participants. A research team member contacted parents primarily by phone and sometimes by email within the week prior to surgery to discuss the study and answer questions. On the day of surgery, parents were again asked if they had any additional questions and if they would be interested in their child participating. Once parents agreed to participate, informed consent was obtained from the parent, and assent was obtained from the child. Playing games with the tablet was deemed as assent by the child.
Protection of human subjects
The study was approved by the Institutional Review Board. To minimize threats to confidentiality, no identifying data were recorded, and all study results were reported in aggregate. Data were maintained in a password-protected file on an encrypted computer, and only the study team had access to the data.
Random assignment
Preschool children were randomly assigned to the midazolam or tablet group. Randomization occurred when the parent or child selected a sealed envelope representing group assignment (Fig. 2).
Preschool children assigned to the midazolam group received a dose of oral midazolam as prescribed by the anesthesia provider (usual and customary care) approximately 15–20 min prior to arrival in the operating room. The usual single oral dose for children prior to general anesthesia is 0.5 mg/kg (
Preschool children in the experimental group were given a tablet with age-appropriate games. Children were able to select games of their choice. Child Life Specialists served as consultants on game selections utilizing knowledge of developmental milestones for preschool children ages 3 to 5. Children had unlimited playtime, which varied from child to child, and continued through mask induction of anesthesia.
Measurement tools
To address the first three study aims, data were collected on anxiety, ED, sedation, and agitation using three measures: the modified Yale Preoperative Anxiety Scale (mYPAS), the Pediatric Anesthesia Emergence Delirium (PAED) scale, and the Richmond Agitation Sedation Scale (RASS) (Fig. 3). After training, the mYPAS and RASS were measured by the pre-operative RN during mask induction and the RASS and PAED were measured by the post-operative RN in PACU (Table 2).
The mYPAS assesses the child's anxiety using a 22-item weighted observational scale with five domains (activity, vocalizations, emotional expressivity, state of apparent arousal, use of parents) (
). Scores range from 23 to 100, with higher scores indicating more anxiety. A categorical variable was created using a cut-off score of 30 or more to indicate anxiety versus no anxiety. No reliability estimates were found in the literature for the mYPAS, which included “use of parents.” However,
Single-blinded randomized controlled study on use of interactive distraction versus oral midazolam to reduce pediatric preoperative anxiety, emergence delirium, and postanesthesia length of stay.
Journal of Perianesthesia Nursing.2019; 34: 567-575
reported internal consistency of >0.90 for the mYPAS-SF, which excluded “use of parents.” Two preoperative nurses were trained to use the mYPAS and achieved high inter-rater reliability (percent agreement 0.96).
Pediatric anesthesia emergence delirium (PAED)
The PAED scale was used to assess the presence of ED in the PACU.
compared the PAED scale to the Watcha and Cravero scale for the presence of ED in children recovering from general anesthesia (including surgical and non-surgical cases).
reported a Cronbach's alpha of 0.96. The PAED scale contains five items assessing behavior (makes eye contact, actions are purposeful, aware of surroundings, restless, inconsolable). The scale utilizes a 5-point Likert scale with total scores ranging from 0 to 20 (
Tablet-based interactive distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: A noninferiority randomized trial.
, we used a cut-off score of 12 to indicate the presence of ED. A categorical variable was created to reflect the presence of ED or no ED. Two postoperative nurses were trained to use the PAED scale in PACU and achieved high inter-rater reliability (percent agreement 0.92).
Richmond agitation sedation scale (RASS)
Sedation and agitation were assessed using the RASS. The RASS is a 10-item observational tool. Scores on the RASS range from negative 5 (unarousable) to positive 4 (combative/violent). The RASS tool has demonstrated reliability (
). For this study, we categorized the RASS scores as agitated, calm, or sedated. Scores of 2 or higher indicated agitation, scores of +1 to −1 indicated calm, and scores of −2 and lower indicated sedation. Inter-rater reliability on the RASS was high following training with two preoperative nurses in the OR (percent agreement 1.00) and two nurses in PACU (percent agreement 0.85).
Statistical methods
Categorical variables were described using frequencies and percentages. Comparisons between groups were made with Pearson's chi-square tests or Fisher's exact tests. Normally distributed continuous variables were presented with means and standard deviations, and comparisons were made with independent sample t-tests. Continuous variables with a non-normal distribution were described using medians and quartiles and compared using Wilcoxon Rank Sum tests. Ordered categorical variables also used Wilcoxon Rank Sum tests to make comparisons between groups. Analyses were performed using SAS® Software (version 9.4; Cary, NC).
Results
Initial recruitment for our study included 184 eligible preschool children (Fig. 2). Several children were excluded due to parents or children changing their minds or physicians' preferences. This resulted in 137 preschool children randomly assigned to the midazolam or tablet group. Attrition in the midazolam group (n = 27; 36%) and tablet group (n = 11; 17%) occurred for multiple reasons, such as the children refusing to participate or on reassessment, the anesthesia team determining the patient did not meet inclusion criteria. Additionally, attrition in the midazolam group occurred when parents opted out of the study because they preferred the tablet group (n = 21; 28%). Three children were lost to follow-up when the study team became busy with other patients and could not assess children in PACU. The final sample included 99 preschool children (midazolam group n = 47; tablet group n = 52).
Most children in the sample were White, with a total mean age (months) of 50.14 (SD 10.293), midazolam group mean age (months) of 48.28 (SD 9.019) and tablet group mean age (months) of 51.83 (SD 11.140). There were no significant differences between age, sex, race, and ethnicity (Table 4). However, there was a significant difference in the types of surgical procedures between groups (p = 0.035), with more children (n = 50, 51%) undergoing ear, nose, and throat procedures (Table 5) than ophthalmology, urology, and general surgery.
For both groups, anxiety was low with a median score of less than the cut point of 30. In addition, there were few cases of ED, with a median score of less than the cut-off score of 12. There was no significant difference in anxiolytic effects of midazolam versus the tablet intervention in this study. There was also no significant difference between groups for ED or sedation and agitation. However, the tablet intervention resulted in a significantly shorter length of stay compared to the midazolam intervention (Table 6).
Table 6Differences in primary outcomes by group.
Factor
Midazolam (n = 47)
Tablet (n = 52)
DF
Test Statistic
p-value
m-YPAS Anxiety Score
28.0 [23.0, 65.0]
25.0 [23.0, 42.5]
N/A
2456.5
0.44
Length of stay
88.0 [78.0, 101.0]
75.5 [59.5, 98.0]
N/A
2686
0.021
PAED final score
8.0 [6.0, 10.0]
8.0 [5.0, 10.5]
N/A
2420.5
0.62
OR RASS code
N/A
2267
0.31
Sedated
1 (2.1)
0 (0.00)
Calm
42 (89.4)
45 (86.5)
Agitated
4 (8.5)
7 (13.5)
PACU RASS code
N/A
2311
0.52
Sedated
45 (95.7)
48 (92.3)
Calm
0 (0.00)
3 (5.8)
Agitated
2 (4.3)
1 (1.9)
Statistics presented as Median [P25, P75], n (column %).
Children's behavior, emotions, and coping strategies are influenced by their psychosocial development. Previous research on preoperative anxiety comparing active distraction techniques to midazolam lacked focus on one stage of development. We explored whether there were differences in anxiety, ED, sedation/agitation, and LOS when comparing active distraction to midazolam in preschool children ages 3 to 5 in the psychosocial stage of initiative versus guilt (
Play distraction versus pharmacological treatment to reduce anxiety levels in children undergoing day surgery: A randomized controlled non-inferiority trial.
Child: Care, Health and Development.2016; 42: 572-581
Children and parental anxiolysis in paediatric ambulatory surgery: A randomized controlled study comparing 0.3 mg kg− 1 midazolam to tablet computer based interactive distraction.
Tablet-based interactive distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: A noninferiority randomized trial.
, we found no significant difference in ED. Previous studies did not include assessment of sedation/agitation (Table 1). This study improved upon other studies by assessing sedation/agitation. However, we found no significant differences between groups.
One significant finding was the difference in LOS, with the tablet group being discharged 12.5 min sooner than the midazolam group. This is consistent with findings reported by
Tablet-based interactive distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: A noninferiority randomized trial.
Single-blinded randomized controlled study on use of interactive distraction versus oral midazolam to reduce pediatric preoperative anxiety, emergence delirium, and postanesthesia length of stay.
Journal of Perianesthesia Nursing.2019; 34: 567-575
. In our study, we allowed children unlimited play- time with the tablet. This contrasts with other studies that allowed children to play between 1 and 60 min (
Play distraction versus pharmacological treatment to reduce anxiety levels in children undergoing day surgery: A randomized controlled non-inferiority trial.
Child: Care, Health and Development.2016; 42: 572-581
Children and parental anxiolysis in paediatric ambulatory surgery: A randomized controlled study comparing 0.3 mg kg− 1 midazolam to tablet computer based interactive distraction.
Tablet-based interactive distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: A noninferiority randomized trial.
Single-blinded randomized controlled study on use of interactive distraction versus oral midazolam to reduce pediatric preoperative anxiety, emergence delirium, and postanesthesia length of stay.
Journal of Perianesthesia Nursing.2019; 34: 567-575
). Overall, our findings support using an active distraction intervention with unlimited playtime as an alternative to pharmacological means as an anxiolytic agent.
Practice implications
In our study, medicating children prior to surgery versus using active distraction resulted in no difference in anxiety. Collaboration with parents, nurses and anesthesia providers is needed to consider the best method to reduce preoperative anxiety in the preschool child. Non-pharmacological methods of distraction, such as the tablet, should be considered as an alternative to medication. In addition, the tablet resulted in a reduced length of stay, which is an important consideration for optimal efficiency in busy surgical centers.
Strengths and limitations
The major strength of our study was the randomized control trial design and homogenous sample of children in the preschool stage of development. Extensive training of co-investigators to maintain inter-rater reliability estimates of 0.80 for the intervention and data collection assured intervention and data fidelity.
As this study was conducted at a single site with a predominantly White sample, findings should be generalized with caution. A major study limitation was the number of patients lost to attrition after randomization: 32% (n = 24) midazolam group and 13% (n = 8) tablet group. Most of the attrition in the midazolam group was due to parental preference (n = 21, 28%), with parents preferring the non-pharmacologic intervention. In addition, two children (3%) in the midazolam group and four children (6%) in the tablet group were excluded per anesthesia after randomization. Attrition may have resulted in a biased sample. Another study limitation is that nurses and the anesthesia team were not blinded to the intervention.
Anecdotally, many parents expressed a preference for their children to have less medicine throughout their surgical experience. At the same time, a change in practice was noted during the study, with physicians ordering pharmacologic interventions less frequently.
Conclusion
The use of tablets as an anxiolytic option appears to be as effective as midazolam for pre-school aged children preoperatively. It also seems to be well received and preferred by many parents. There is potential that the use of the tablet, as compared to midazolam, may result in a shorter LOS. Future researchers should consider replicating this study with different developmental age groups.
Funding statement
NuRF Research Grant from Office of Nursing Research and Innovation, Cleveland Clinic.
CRediT authorship contribution statement
Michelle Levay: Conceptualization, Investigation, Writing – original draft, Project administration, Funding acquisition. Megan Sumser: Investigation, Writing – review & editing. Kristen Vargo: Supervision. Alina Bodas: Supervision, Resources. James F. Bena: Formal analysis. Cynthia A. Danford: Writing – review & editing. Sandra L. Siedlecki: Methodology, Validation, Writing – review & editing.
Conflict of interest statement
The authors have no known conflict of interest, financial or other, to disclose.
Acknowledgments
The authors wish to express our deepest appreciation to the following co-investigators for their dedication to the study and our patients: V. Seward, RN, CPN, J. Dingenary, RN, CPN, J. Mason, BSN, RN, CPN, E. Kampman, RN, CPN, M. Romanak, BSN, RN, CPN, T. Billingsley, MSN, RN, CPNP-AC, and A. Sammon, MS, CCLS. We would also like to acknowledge the Cleveland Clinic pediatric surgeons for graciously allowing us to enroll their patients. A special thank you goes to the Pediatric Anesthesia Staff and CRNA team including D. Markakis, MD, FAAP, Chair, Department of Pediatric Anesthesiology. Finally, we would also like to express our gratitude to the Office of Nursing Research & Innovation and Associate Chief Nursing Officer, Dr. N. Albert, PhD, CCRN, FAAN.
References
Al-Yateem N.
Brenner M.
Shorrab A.A.
Docherty C.
Play distraction versus pharmacological treatment to reduce anxiety levels in children undergoing day surgery: A randomized controlled non-inferiority trial.
Child: Care, Health and Development.2016; 42: 572-581
Children and parental anxiolysis in paediatric ambulatory surgery: A randomized controlled study comparing 0.3 mg kg− 1 midazolam to tablet computer based interactive distraction.
Tablet-based interactive distraction (TBID) vs oral midazolam to minimize perioperative anxiety in pediatric patients: A noninferiority randomized trial.
Single-blinded randomized controlled study on use of interactive distraction versus oral midazolam to reduce pediatric preoperative anxiety, emergence delirium, and postanesthesia length of stay.
Journal of Perianesthesia Nursing.2019; 34: 567-575
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