Description

Study Protocol:

This is a prospective, randomized controlled trial of children 3-9 years of undergoing non-complex ENT procedures to assess the impact of perioperative personalized music on the incidence of emergence agitation (EA).

There will be 2 groups in the study:

• Personalized music group
• Standard care group

All patients enrolled in this study will receive a standardized anesthetic consistent with standard practice at the Stanford Children's Hospital based on their type of procedure:

Patients undergoing myringotomies will receive:

• Oral midazolam (0.5mg/kg up to a maximum of 20mg) preoperatively, unless clinically contraindicated
• Inhalational induction of anesthesia, either with a combination of nitrous oxide and sevoflurane or 8% sevoflurane, depending on provider preference and clinical context
• A combination of fentanyl (1 mcg/kg) and ketorolac (0.5 mg/kg) given in a single intramuscular (IM) injection, given while under anesthesia in the operating room.

Patients undergoing tonsillectomies will receive an anesthetic regimen consistent with common practice at Lucile Packard Children's Hospital

While these anesthetic regimens will serve as the default for study patients, the perioperative care team may deviate if clinically warranted in their judgement.

All patients will be assessed post-operatively for emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) assessment tool (described in "Procedures"). All patients will also be assessed for anxiety using the modified Yale Preoperative Anxiety Scale (mYPAS) while in the preoperative area. Patients will also be assessed for mask acceptance on induction of anesthesia (ICC), and pain after their procedure using the FLACC, Wong-Baker FACES, or VAS scale (appropriate scale will be determined based on patient age and clinical context).

All patient guardians will be assessed for anxiety using the State-Trait Anxiety Inventory (STAI) during the procedure (described in "Procedures"). These assessments are validated for use in this age group.

Data collection: Patient demographic information, clinical documentation (clinic notes, procedure reports, labs, anesthesia records, imaging reports etc.) will be collected. Data collection sheet attached.

Data analysis:

Pediatric Anesthesia Emergence Delirium (PAED) scores will be used as our primary outcomes measure to assess for emergence agitation, which is a 20-point scale and assumes a normal distribution. The investigators plan to collect six PAED scores for each patient taken at 10 minute intervals following completion of each procedure for all participants. Participants will be divided randomly into two groups: half with music, and half without music. The Investigators anticipate an incidence of emergence agitation in the range of 10-20% (defined as a PAED score of 12 or greater) based our subject group and literature review. To assess for a difference in PAED scores between groups, with a Type 1 error of 0.05, and a power of 0.8, the investigators estimate a need of 40 participants per group (80 participants total) to detect an effect size of 0.3. The investigators plan to recruit 100 total participants in order to account for potential withdrawals or protocol deviations. Secondary measures of interest include the modified Yale Preoperative Anxiety Scale (mYPAS), mask acceptance, and post-operative pain.

Data Safety Monitoring Plan:

The principal investigator will review subject enrollment, adverse events, unanticipated occurrences, and protocol deviations. Any adverse events meeting criteria will be reported to the IRB. The investigators will follow the guidelines in the IRB's Adverse Event and Unanticipated Problems Reporting Policy.

Significance

Personalized music may help to decrease EA in children undergoing elective surgeries under general anesthesia by decreasing perioperative anxiety and minimizing perceived pain. The study has the potential to improve perioperative care by improving safety, decreasing the need for postoperative pharmacologic and nursing interventions, thereby shortening the time of recovery and improving caregiver satisfaction.