In 2015, the pediatric post-anesthesia care unit (PACU) at Cleveland Clinic’s main campus began giving iPads to pediatric patients with unexpected long wait times prior to surgery. “We soon noticed the children were so happily playing with the iPads that they were no longer complaining about being hungry or thirsty,” says Michelle Levay, MSN, RN, CPN, assistant nurse manager of the pediatric PACU. “They were occupied, and parents were content to see that their children were no longer crying and upset.”
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That led Levay and two of her colleagues in the PACU, TeNeasha Billingsley, MSN, RN, and Megan Sumser, BSN, RN, to question the unit’s preoperative medication standard of care. Children were given midazolam orally prior to surgery to induce sedation and minimize anxiety. Nurses wondered if patients might benefit from an equally effective nonpharmacologic intervention. Their curiosity led to a research study under the tutelage of Sandra L. Siedlecki, PhD, RN, APRN-CNS, a senior nurse scientist in Cleveland Clinic’s Office of Nursing Research and Innovation.
The study purpose and design
The purpose of the study was to compare the effects of midazolam (standard care) and use of an interactive tablet-like electronic distraction device in 3- to 5-year-old children preoperatively. Levay and her team of co-investigators sought to ascertain if there was a difference in anxiety, incidence of emergence delirium, pre- and postoperative sedation/agitation, and length of stay.
The randomized controlled trial included 99 patients recruited between April 2017 and March 2019. Patients were classified as American Society of Anesthesiologists Class I (a normal healthy patient) and Class II (a patient with mild systemic disease) who were scheduled for elective surgeries within the otolaryngology, urology, ophthalmology and general surgery areas. Preoperatively, children were randomly assigned to one of two groups: 48 received midazolam (control group) and 51 received an interactive tablet-like electronic distraction device (intervention group). Children were excluded if the anesthesia provider determined it was in the best interest of the child to be pre-medicated with midazolam before surgery.
The nurses utilized the following outcomes and measurement for their study:
- Anxiety: Modified Yale Pre-operative Anxiety Scale (higher scores indicated greater anxiety).
- Emergence delirium: Pediatric Anesthesia Emergence Delirium scale (scores greater than 12 indicated emergence delirium).
- Agitation and sedation: Richmond Agitation Sedation Scale (to code as agitated, sedated or neither).
- Length of stay: By review of medical record data (based on days from PACU admission to discharge).
Results of the study
“In preliminary analysis, there was no significant difference between emergence delirium, agitation, sedation, anxiety or length of stay between groups,” says Levay. “We were actually pleased with these results, as it means that providers have options in relation to preoperative care. Medicating children prior to surgery may not be necessary, as an anti-anxiety medication was not superior to the interactive tablet-like electronic distraction device.”
Levay acknowledges that midazolam is an excellent medication when children are extremely anxious. If a child walks into the unit crying and afraid, then midazolam may be the best option. However, children who are relatively calm and cooperative are ideal candidates for the interactive tablet-like electronic distraction device intervention. Anecdotally, parents seemed to prefer the interactive tablet-like electronic distraction device intervention to medication: 21 families opted out of the study after randomization to the control group (midazolam) because they preferred the experimental treatment.
“Technology is constantly evolving, and there are many different tools available to help distract children from the stress of being in the hospital,” concludes Levay. “The most important takeaway of the study is that nonpharmacological methods for reducing anxiety are equally as effective as midazolam.”
All medications have side effects; using sedative/anti-anxiety medications can cause respiratory depression and, in rare cases, a paradoxical reaction where children become excessively agitated. “Parents told us that they wanted their children to have less medicine overall, including during the preoperative period,” says Levay. “Our intervention may not only be a great distractor for children; it may minimize preoperative over-sedation.”