Music as an adjunct to combination analgesia for neonatal circumcision: A randomized controlled trial.

INTRODUCTION: Neonatal circumcision is one of the most frequently performed procedures in male infants; it is also particularly painful. In a previous trial, we showed that the combination of Eutectic Mixture of Local Anesthetics (EMLA) + Sucrose + Ring Block (RB) was significantly effective in reducing pain during circumcision. OBJECTIVE: In this study, we added music as an adjunct aiming to further reduce the pain scores. STUDY DESIGN: This was a double-blinded randomized controlled trial comparing EMLA + Sucrose + RB (Control) to EMLA + Sucrose + RB + Music (Intervention). The trial setting was the normal nursery of a university teaching hospital. One hundred and three healthy newborn males were randomized to each of the intervention and control groups. Babies were videotaped (face and torso) during the procedure for assessment of pain by two blinded and independent reviewers. The primary outcome measure was the NIPS score; secondary outcomes included heart rate, oxygen saturation and crying time. RESULTS: The NIPS score of the intervention group (EMLA + Sucrose + RB + Music [2.6 ± 1.6]) was significantly higher than that of the control group (EMLA + sucrose + RB [1.4 ± 0.9]) (p = 0.00). Inter-rater reliability was high (κ .89). The intervention group registered significantly higher mean heart rate (142 bpm) and increased mean crying time (5.44 s) compared to the control group (135 bpm and 1.63s, respectively) (p = 0.01) and (p = 0.00). No adverse events were noted. Delivery music medicine by playing it from an iPad in the procedure room did not reduce pain during circumcision. DISCUSSION: There is overwhelming evidence in the literature describing the effectiveness of music on pain management especially in the NICU. However, our results did not align with the general trend; not only did music medicine fail to enhance analgesia but it might have had the opposite effect, further agitating the infants, as indicated by the significantly increased heart rate, crying time and NIPS scores of the participants in the intervention group. Limitations of our study include the fact that this is a single center study and the method of delivering music via iPads instead of noise-canceling headphone. CONCLUSION: Our results showed that music, delivered in this manner, may have increased agitation. We affirm the fact that the combination of EMLA + Sucrose + RB is highly effective for managing pain during circumcision and further reduction of already low scores might not be possible. CLINICAL TRIAL REGISTRATION: Registry Name: ClinicalTrials.gov; Registration number: NCT04252313; link: https://clinicaltrials.gov/ct2/show/NCT04252313.

In Situ Simulation: An Essential Tool for Safe Preparedness for the COVID-19 Pandemic.

INTRODUCTION: Working under extreme stress can cause medical professionals to deviate from clinical guidelines even if they know of their existence, let alone in situations such as COVID-19 where guidelines are unclear, fluid, and resources limited. In situ simulation has been proven an effective tool for training medical professionals during previous healthcare crises, eg, Ebola, influenza, as well as for assessing the preparedness of centers by identifying potential latent safety threats. In this article, we describe our ongoing simulation activities to ensure that our staff is best prepared to adapt to the challenges of COVID-19. METHODS: This is a prospective preparedness assessment and training intervention at a tertiary care academic center in Lebanon during the COVID-19 pandemic. In situ simulations followed by debriefing with good judgment occur daily involving native teams of 3 to 5 professionals in the newly established COVID intensive care unit and wards, the adult and pediatric intensive care unit and wards, and the emergency department. The simulations are assessed by the instructor using the Simulation Team Assessment Tool and by the participants using the Simulation Effectiveness Tool. Transcripts of recorded simulation debriefings are analyzed for content for latent safety threats using the SHELL Framework (Software-Hardware-Equipment-Liveware). RESULTS: In 2 weeks, we conducted 15 simulations with 106 participants and 47 observers. Simulation Team Assessment Tool scores show an overall improvement across the hospital over time [101.5 ± 13 (80-134)]. Participants' feedback on the Simulation Effectiveness Tool has been predominantly positive on the educational and practical benefits of the simulation activity. Data from debriefings and observations demonstrated the following categories of latent safety threats: inadequate preparedness on infection control, uncertainty of guidelines on oxygen supplementation and intubation protocols, lack of leadership and communication, overall panic, and others. CONCLUSIONS: Our single-center preparedness intervention demonstrated multiple latent safety threats in relation to COVID-19, which can be recognized through simulation before translating into actual patient care.

In-situ simulations for COVID-19: a safety II approach towards resilient performance.

BACKGROUND: COVID-19 has taken the world by surprise; even the most sophisticated healthcare systems have been unable to cope with the volume of patients and lack of resources. Yet the gradual spread of the virus in Lebanon has allowed healthcare facilities critical time to prepare. Simulation is the most practical avenue not only for preparing the staff but also for troubleshooting system's latent safety threats (LSTs) and for understanding these challenges via Hollnagel's safety I-II approaches. METHODS: This is a quality improvement initiative: daily in situ simulations were conducted across various departments at the American University of Beirut Medical Center (AUBMC), a tertiary medical care center in Beirut, Lebanon. These simulations took place in the hospital with native multidisciplinary teams of 3-5 members followed by debriefing with good judgment using the modified PEARLS (Promoting Excellence and Reflective Learning in Simulation) for systems integration. All participants completed the simulation effectiveness tool (SET-M) to assess the simulation. Debriefings were analyzed qualitatively for content based on the Safety Model and LST identification, and the SET-Ms were analyzed quantitatively. RESULTS: Twenty-two simulations have been conducted with 131 participants. SET-M results showed that the majority (78-87%) strongly agreed to the effectiveness of the intervention. We were able to glean several clinical and human factor safety I-II components and LSTs such as overall lack of preparedness and awareness of donning/doffing of personal protective equipment (PPE), delayed response time, lack of experience in rapid sequence intubation, inability to timely and effectively assign roles, and lack of situational awareness. On the other hand, teams quickly recognized the patient's clinical status and often communicated effectively. CONCLUSION: This intervention allowed us to detect previously unrecognized LSTs, prepare our personnel, and offer crucial practical hands-on experience for an unprecedented healthcare crisis.