Prospective study evaluating the quality of care perceived by paediatric patients undergoing Procedural Sedation and Analgesia in the Emergency Department and their caregivers

Introduction: Acute pain is a common condition treated in Paediatric Emergency Department (PED) and the fact that painful procedures are usually unexpected, increases hospital-related stress and anxiety that may affect procedure outcomes, caregivers’ collaboration and patients’ compliance. Therefore, paediatric patients require mild-moderate procedural sedation and analgesia (PSA). Research focused on paediatric PSA and its clinical efficacy, only few studies evaluated patients’ and caregivers’ subjective experience that reflects the quality of care offered. Aim of study: to assess the perception of children and their families/caregivers about their experience with PSA procedures in the PED. To establish how best to approach the patient and families in the context of procedures under PSA, understand which elements of care the user places the greatest value on and improve the current clinical practice to provide the best quality of care. Identify possible side effects presenting after discharge. Materials/Methods: The study is a single-centre prospective observational pilot cohort study conducted at the PED of Women’s and Children’s Health of Padova. Caregivers enrolled signed an informed consent and received two questionnaires: one at time zero (T0), within discharge, and another to fill in 48 hours after (T48). At T0 we collected demographics, global PED experience and global PSA experience data; at T48 the survey focused on postponed PSA adverse effects. Healthcare providers fulfilled a single survey at T0 and collected data about type of procedure and PSA used (drugs and doses), adverse effects, time of sedation, patient/caregiver collaboration. Anonymized data have been collected using REDCap platform. Primary outcome: perception of children and their families/caregivers regarding their PSA experience in the PED. Secondary outcome: level of satisfaction in association with specific factors and type and frequency of possible side effects presenting after discharge. Results: The study enrolled 74 patients; only 42/74 (57%) caregivers completed the survey at T0; 18/42 24% of them at T48. 37/74 (50%) were female; most of the children 53/74 (72%) were under 5 years of age. 24/42, (57%) of caregivers were 26-40 years old; their level of schooling was medium-high in 33/42 (79%) of cases. The most routinary procedures carried out using PSA were wound suturing (57%), vascular access placement (12%), diagnostic imaging as CT scan (11%) and fracture reduction (7%). Non-pharmacological techniques were used in most of the cases, always embedded with other drugs; among systemic drugs, the most frequent were midazolam (36/74, 49%), ketamine (24/74, 32.4%) and nitrous oxide (8/74, 10.8%). Transmucosal route was preferred for midazolam (66%) and fentanyl (83%); intravenous administration was ketamine (88%) and dexmedetomidine (83%) first choice. In 51% cases the onset time of sedation was in a range of time between 5-30 minutes; less than 30 minutes the time of wash out (46%). No severe adverse events have been reported. Caregivers and patients’ collaboration/compliance improved after PSA (from 59.5% to 89.2%). Overall ED experience satisfaction and overall PSA satisfaction were high, respectively (Mean: 27.2, SD: 2.5968) and (Mean: 31.7, SD: 3.6041). 72% of caregivers reported they would agree on repeating the experience with PSA in the future. The length of stay in the paediatric ED showed to significantly have an impact on satisfaction towards paediatric ED (p-value: 0.045). Conclusions: The level of caregivers’ satisfaction with respect to both procedural sedation and analgesia and the care received in PED was high despite a considerable proportion of caregivers completing the questionnaire at T48 (18%) wouldn’t repeat PSA in the future. The short time of stay in PED had a positive impact on the quality of the service provided. Future implementations are needed.