A Randomized Controlled Trial of Intrathecal versus Caudal Morphine-Bupivacaine on Postoperative Analgesia and Cortisol Levels in Pediatric Patients
Bupivacaine on Postoperative Analgesia and Cortisol Levels in Pediatric Patients
Anesthesia Analgesia
Submitted September 2025 by Dr Stephanie Pauling
Read by 36 Journal Watch subscribers
This study compared the analgesic outcomes of caudal morphine and bupivacaine with intrathecal morphine and bupivacaine in patients aged 1-5 having general, urological and orthopaedic surgery below the umbilicus.
Forty patients (aged 1-5 and weighing at least 10kg) were recruited in a single centre in New Delhi over a year-long period, and were randomised to receive either caudal bupivacaine and morphine (“caudal group”; 0.25% bupivacaine and 40mcg/kg morphine) or intrathecal bupivacaine and morphine (“ITM group”, 0.5% heavy bupivacaine and 4mcg/kg morphine) in addition to their standardised general anaesthetic. The primary endpoint was time to a FLACC score of >=4. The secondary endpoints were the need for rescue analgesia, cortisol levels (as a surrogate for stress response) and parental satisfaction with analgesia. It produced some emphatic results - heavily in favour of intrathecal morphine.
100% of the caudal group reached a FLACC score of 4 or above in the first 24 hours, but only 25% of the ITM group did, meaning that the results were presented as Kaplan-Meier curve.
Significantly more caudal patients received rescue fentanyl intra-op and in PACU, and all of them needed post-operative paracetamol, compared with only 30% of the ITM patients. Cortisol levels were lower in the ITM group and never became elevated above baseline (though this could be attributed to the dense spinal block from the bupivacaine). Parental satisfaction with analgesia was high in the ITM group and low in the caudal group. There was no significant difference in the side effect profile between the two groups.
Strengths
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The trial was an RCT; the general anaesthetic management was standardised, and a single operator performed all the neuraxial procedures, thereby minimising inter-operator variability.
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Apart from the proceduralist (who was the PI), all the data collectors, recovery and ward nurses, and parents were blinded to the intervention.
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It demonstrated a very clear difference in favour of ITM in a previously under-studied population (young children having non-spinal surgery).
Shortcomings:
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Small, single centre study (though this allowed for good standardisation of anaesthetic technique, which consisted of intravenous midazolam premedication, an iv induction with fentanyl and propofol, paralysis and intubation, and sevoflurane maintenance to a MAC of 0.7)
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No follow up after the primary endpoint of 24 hours, which means we may have missed gathering some valuable information on the actual duration of action of ITM
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Large sex imbalance in the ITM group, which may be significant given that males and females undergo different types of surgery below the umbilicus, and also, there may be sex differences in pain perception and expression – a nebulous area which is difficult to research, especially in this age group.
Take home message
Intrathecal morphine gives longer lasting analgesia, reduces serum cortisol levels, and results in greater parental satisfaction than caudally administered morphine in children aged 1-5 undergoing infra-umbilical surgery. The demonstration of superiority of ITM over caudal morphine is generally applicable to our setting, although we should note that the conduct of the general anaesthetic component may not represent typical paediatric anaesthetic practice in Australia or New Zealand.
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Safety of Intrathecal Clonidine as an Adjuvant to Spinal Anesthesia in Infants and Children
Pediatric Anesthesia
Submitted September 2025 by Dr David Roche
Read by 59 Journal Watch subscribers
This retrospective chart review explores the safety of intrathecal clonidine in infants and children up to 3 years of age who received spinal anaesthesia.
Methods
In this single centre study the authors conducted a search of the electronic medical record to identify paediatric patients who had received spinal anaesthesia with intrathecal clonidine. Demographics, procedure details and several safety outcomes were captured, these included:
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Oxygen desaturation defined as O2 Sats <92%
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The need for supplemental oxygen
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Bradypnea or apnoea
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Need for bag-valve-mask ventilation.
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Bradycardia (defined as heart rate ≤ 80 beats per minute)
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Hypotension (defined as systolic blood pressure (sBP) ≤ 60 mmHg)
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Clinical need for the administration of fluid boluses or vasoactive/anticholinergic medications
The typical anaesthetic agent used was described as 1 mg/kg (up to 1.2 mL) of 0.5% isobaric bupivacaine with epinephrine 1:200000 and 1 μg/kg of clonidine
Results
The cohort included 1420 patients who received spinal anaesthesia with intrathecal clonidine between 2016 and 2022. The a median age was 7 months (ranging from newborn to 3 years). 98% of patients were males. 5.3% of patients required conversion to general anaesthesia and 26.6% of patients required additional sedation intraoperatively. From a safety perspective the authors report intraoperative bradycardia in 2% of patients and hypotension in 17% based on the parameters outlined above. 93% of patients were discharged home on the day of surgery with a median post operative time in the theatre suite of 82 minutes.
Discussion
This study describes a large cohort of patients who received spinal anaesthesia with adjuvant intrathecal clonidine. Clonidine is used to prolong the duration of spinal block. The authors report no significant adverse events and based on their defined safety parameters suggest that clonidine is a safe adjuvant to spinal anaesthesia.
They acknowledge a number of limitations to this retrospective study – particularly the lack of data related to gestational age at birth or corrected post conceptual age on the day of surgery. Given the wide age range of the cohort reviewed, care should be taken when applying the reported safety profile to the pre-term or ex-pre term infant; the authors do however reference a study by Rochette et al which found no significant adverse events when spinal anaesthesia with 1mcg/kg of clonidine was administered to infants <60 weeks post conceptual age.
Furthermore, the definitions of bradycardia and hypotension in this study were fixed and applied to patients across a wide age range where physiological norms differ. This may have led to errors in the identification of adverse events.
Take Home Message
This paper provides a detailed description of a spinal anaesthesia program which utilizes adjuvant clonidine in infants and young children, with a high proportion of patients being discharged home on the same day. Given the wide age range of included patients, care should be taken when applying the reported safety profile to the neonate or ex-preterm infant.
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Impact of liberal preoperative clear fluid fasting regimens on the risk of pulmonary aspiration in children (EUROFAST)
An international prospective cohort study
British Journal of Anaesthesia
Submitted September 2025 by Dr Meghan Cooney
Read by 111 Journal Watch subscribers
Overview
The EUROFAST (European Preoperative Fasting Audit) project demonstrated that more liberal clear fluid fasting (≥1 hour) before anaesthesia in children is non-inferior to the more traditional ≥2 hour interval and does not increase the risk of pulmonary aspiration.
Pulmonary aspiration is a rare event in children, and thus a very large sample size is needed to provide reassurance regarding the safety of updates to fasting regimens.
This project set out to compare the risk of pulmonary aspiration with regard to three different clear fluid fasting regimens; sip-til-send, ≥1 hour and ≥2 hours. The allocation to these groups was by intention to treat, not actual clear fluid fasting times.
Methods
Prospective multicentre cohort study that began in Sweden and expanded to an international cohort (beyond Europe).
For other aspects of fasting, an interval of ≥6 hours was required for solid food, ≥4 hours for breastmilk or formula.
This study did not collect actual fasting times for every patient included: this was only assessed for patients who had an aspiration event. The groups are allocated according to each institution’s fasting protocol.
Results
This study included 306, 900 anaesthetic procedures from 31 centres in patients 0-16 years old:
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Sip til send 34,028
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≥1 hour 251,021
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≥2 hour 21,851
The incidence of aspiration for each group was 1.83 vs 0.68 vs 1.18 per 10,000 patients for ≥2 hour, ≥1 hour and sip til send respectively. When combined together, sip til send and ≥1 hour clear fluid fasting protocols were noninferior to ≥2 hour clear fluid fasting in terms of confirmed aspiration and regurgitation with symptoms and escalation of care. This audit may not be adequately powered to definitively declare that ‘sip til send’ does not have a higher rate of aspiration/regurgitation events compared with more traditional fasting protocols.
There were 420 registered aspiration events; 286 categorised as transient (68%), 94 requiring escalation of care (22%) and 40 leading to post-operative intensive care (9.5%). There were no reported deaths, cardiac arrests or aspirations leading to brain damage. Only 18 children with <1 hour actual clear fluid recorded fasting times were involved in any kind of aspiration event, and none of these required intensive care.
This study was not designed to detect risk factors for aspiration, but it remains interesting to see that gastrointestinal anatomical and mobility disorders were implicated in 28% and 18% of these cases, respectively. Emergency surgery and comorbidities were also associated with aspiration. These risk factors are similar to those found in existing literature.
Discussion
This study did not collect actual fasting times for every patient included: this was only assessed for patients who had an aspiration event. Whilst analysis of exact fasting times would have advantages, this study is able assess according to institutional fasting protocols which may reflect a more ‘real life’ approach.
A limitation of this study is that it relied upon anaesthetists to report cases of aspiration or regurgitation, leading to reporting bias (with a very high incidence reported at one particular centre). Whilst its strengths include large case numbers and geographically diverse populations, there is potential for confounding factors due to differences in anaesthesia practice between different centres and clinicians.
Take Home Messages
This study significantly reinforces existing literature that shorter clear fluid fasting intervals prior to anaesthesia do not increase the risk of aspiration/regurgitation.
Importantly, in the rare instances where aspiration or regurgitation events occurred in children, there was no significant morbidity of mortality, although a portion required escalation of care.
This paper supports transition to more liberal clear fluid fasting protocols for children undergoing anaesthesia.
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Is the Compassion of Anesthesiologists Associated With Postoperative Pain and Patient Experience? A Prospective Cohort Study
Anesthesia Analgesia
Submitted September 2025 by Dr Andrew O’Donoghue
Read by 51 Journal Watch subscribers
Summary
This study, published in Anaesthesia & Analgesia (2025), investigates the role of anaesthesiologist compassion in shaping postoperative outcomes among patients undergoing same-day surgery. The authors begin by situating compassion within the broader context of medical care, noting prior evidence linking compassionate interactions with improved outcomes in chronic disease and primary care, as well as reduced perioperative anxiety and pain. Compassion is carefully distinguished from empathy: empathy being resonance with patient emotions, while compassion implies concern accompanied by a desire to help.
In modern surgical care, where anaesthesiologist-patient interactions are often limited to the day of surgery, opportunities for meaningful compassionate engagement are compressed. The study aimed to test whether higher levels of perceived compassion from the anaesthesiologist, as rated by patients, were associated with lower postoperative pain scores, with preoperative state anxiety hypothesised as a mediator. Exploratory outcomes included opioid consumption and patient experience metrics.
This was a prospective, single-centre observational study enrolling 147 patients between March 2021 and June 2022. Eligible patients underwent open abdominal, gynaecological, urological, oncological, or breast surgery in an ambulatory or 23-hour admission context. Compassion was measured using a validated five-item scale; anxiety was assessed using the State-Trait Anxiety Inventory; and pain was measured on an 11-point Likert scale over postoperative days (POD) 0–3. Analyses included correlation testing, linear mixed models, and counterfactual-based mediation to isolate the effect of anxiety in the compassion–pain relationship.
Results
The cohort was predominantly female (87%) and white (73%), with a median age of 50 years. Half underwent breast surgery, and 35% had abdominal surgery. Missing data were minimal (≤11% overall for pain scores).
The key finding was that higher compassion ratings were significantly associated with reduced state anxiety after the anaesthesiologist interview, and this reduction in anxiety mediated lower postoperative pain scores on POD 0. Specifically, for each unit increase in compassion, state anxiety decreased by 0.38 points (P = .0045). The mediated reduction in pain on POD 0 ranged from −0.02 to −0.13 on the Likert scale. By POD 1, the mediation effect unexpectedly reversed direction (increased pain with higher compassion), which the authors attributed to unmeasured home and social factors after discharge. No significant effects were observed on POD 2–3.
Compassion scores were also strongly associated with improved patient experience ratings on CAHPS-derived measures (ρ = −0.53, P < .01). As expected, opioid consumption correlated positively with pain across all postoperative days, but compassion did not show a direct association with opioid use.
Commentary
This study provides novel empirical evidence that compassion from anaesthesiologists can meaningfully reduce immediate postoperative pain, mediated by reduced preoperative anxiety. Its strengths include the use of validated scales for compassion and anxiety, prospective data collection, and adherence to STROBE reporting standards. The application of a mediation model based on counterfactual analysis allowed for a nuanced exploration of causal pathways.
However, several limitations temper the generalisability of findings. First, the single-centre design, predominantly female and white cohort, and high proportion of breast surgery cases introduce selection bias. Exclusion of laparoscopic and orthopaedic surgeries further narrows applicability. The sample size (n = 147) is modest, raising concerns about statistical power, especially for mediation analyses across multiple days.
Second, while blinding anaesthesiologists to outcomes was a strength, all providers were informed of the study beforehand, raising the possibility of a Hawthorne effect. Patients also knew compassion was being rated, which could have influenced perceptions. The absence of compassion assessments for resident or nurse anaesthetist interactions may also overlook key contributors to patient experience.
Third, the observed effect on pain was modest in magnitude and confined to POD 0, diminishing quickly after discharge. This suggests compassion’s impact may be context-dependent, most salient in the anxiety-provoking perioperative hospital environment. The unexpected association with increased pain on POD 1 highlights the influence of unmeasured external factors, such as social support or discharge preparation.
Despite these caveats, the study has important implications. It underscores the anaesthesiologist’s unique role in mitigating preoperative anxiety – a near-universal phenomenon among surgical patients – which in turn may reduce pain and improve satisfaction. The findings support integrating compassion training into anaesthesiology residency curricula and suggest future research should explore structured interventions (e.g., communication training, empathy-focused scripts) in larger, more diverse cohorts.
This study adds weight to the argument that compassion is not merely an interpersonal virtue but a measurable, clinically relevant factor in perioperative care. While limited by scope and design, it provides a valuable foundation for future trials examining compassion as an intervention to improve surgical outcomes.
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The promise of precision
Exploring the role of remimazolam in paediatric anaesthesia
British Journal of Anaesthesia
Submitted August 2025 by Dr Ayaka Omori
Read by 79 Journal Watch subscribers
This narrative review serves as an update on the use of remimazolam in paediatric population.
The introduction of remimazolam is a notable development in hypnotics in the past two decades.
Remimazolam has advantages because of its predictable pharmacokinetics due to rapid onset (1-2 mins), short duration (5-20 mins), predictable metabolism (elimination half-life 5-10 mins) with minimal accumulation (context-sensitive half-life likely short and stable).
It also promises a remakrable safety profile, with the absence of adverse events such as hypotention, respiratory depression, or bradycardia. It has already established antagonist flumazenil.
Remimazolam could be a safer alternative in high risk population where haemodynamic and respiratory stability is paramount.
With these advantages and despite its growing use in adult anaesthesia and sedation, clinical data and experience with remimazolam in the paediatric population remains limited, especially in neonates and infants. Recently, Cai et al. provided dosing estimates for children, reporting the ED₅₀ and ED₉₅ values. Based on their findings, the recommended dosing range is 0.45–0.60 mg/kg for children aged 1–6 years and 0.35–0.45 mg/kg for those aged 6–12 years.
However, the authors describe several gaps remain in our understanding of remimazolam use in children, and outline the following priorities for further research:
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Safety, efficacy and cost-effectiveness are yet to be evaluated in the broader paediatric population. Potential heterogeneity has been reported in remimazolam metabolism due to variability of carboxylesterase 1 activity, which plays a key role in the drug metabolism. Safety for vulnerable cohorts such as neonates also need to be examined.
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Comparative trials against commonly used agents such as propofol and midazolam will be necessary to establish clinical superiority or equivalence.
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The development of a robust target-controlled infusion (TCI) model for paediatric use, along with a deeper understanding of remimazolam’s interactions with opioids and neuromuscular blocking agents, would further bolster remimazolam's utility in the clinical sphere.
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Evaluation of the Pediatric Regional Anesthesia Time-Out Checklist
A Simulation Study
Pediatric Anesthesia
Submitted August 2025 by Dr Su May Koh
Read by 85 Journal Watch subscribers
This simulation-based study examined the effect of a Paediatric Regional Anaesthesia Time-out Checklist training for pediatric anaesthetists and trainees. Not surprisingly it found that checklist training and having a shared-mental model led to an increased number of safety items performed before a simulated anesthetic block scenario.
The Society for Paediatric Anesthesia Quality and Safety Committee developed a 14 item Paediatric Regional Anesthesia Time-Out Checklist and in the process of evaluating and testing the checklist designed a study to observe the behaviours of 11 attending anesthesiologists and resident dyads in 132 simulated scenarios.
There were 12 scenarios developed of which in 4 scenarios, medical staff were expected to decline performing the block due to a safety concern (programmed error) in the scenario (eg coagulation issues or excessive local anesthetic doses). The scenarios were designed to encompass types of errors previously reported in the literature making them more relevant. Medical staff in pairs (attending/consultant anesthesiologist with resident/trainee) completed 6 medium fidelity simulation scenarios (two of which had a programmed error). This was followed by completion of a survey and then checklist training. After the training, the pairs completed 6 further medium fidelity simulation scenarios (again with two scenarios having a programmed error). This was followed by a debrief and survey completion.
Each scenario was expected to last 2-4 minutes and each attending and trainee were given different stem cards and expected to communicate. No specific instructions were given about who should initiate the checklist time-out and the scenario ended when the block needle was inserted. Video recordings of the scenarios were performed and scored for safety items achieved and whether the decision to perform the block or abort the block was recorded.
Results
132 simulated scenarios were performed by 22 anesthesiologists. In terms of the study’s primary outcome, they found that a greater number of safety items were completed after training on the Pediatric Regional Anesthesia Time-Out Checklist for each of the 11 pairs (p=0.002). Of note 78% of safety items studied were performed after training and 41% of safety items were performed prior to training. The authors also found that the team’s choice to perform or abort the regional anesthetic occurred (as expected) more often after the Checklist training (p=0.001). Of note prior to checklist training in 3 scenarios, teams chose to perform the regional anesthetic block despite a programmed error (safety concern). Two of the scenarios involved a patient with a low platelet count having a neuraxial block where before checklist training the medical staff elected to proceed with the block. Interestingly after the checklist training no teams chose to perform the blocks in scenarios where there were safety concerns/programmed errors.
The checklists were overall favourably rated for usability and design and participants thought favourably of checklists in the medical setting.
Commentary
This study is interesting as it examines checklist testing using pairs of anesthesiologists namely an attending and a trainee, promoting additional team interaction and a shared mental model. The authors commented that the number of times that each pairing had worked together previously varied thus potentially showing the utility of the checklist even for teams of variable interpersonal familiarity. A possible limitation includes the learning effect in a simulated environment with a relatively small sample size. The authors also commented that this was a single site study in a centre with a high safety culture and where checklists were widely accepted, this may not be true of all paediatric centres.
Take-Home Messages
Even though serious adverse events are rare in pediatric regional anesthesia, potential complications such as wrong-sided blocks, local anesthetic dosing errors may be prevented by the use of checklists and clear communication. A block time-out with a checklist is now an expected and important part of ensuring patient safety. This may be particularly true in pediatric anesthesia where the majority of our blocks are performed in anesthetised patients.
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Safety and Sustainability of Axillary Versus Radial Arterial Catheters in Critically Ill Children
A Retrospective Comparative Study
Pediatric Anesthesia
Submitted August 2025 by Dr Eamonn Upperton
Read by 106 Journal Watch subscribers
This retrospective cohort study examines axillary arterial lines placed in PICU patients to compare their safety profile with radial arterial lines, and provides some baseline data to support their use as a second line option.
Methods
The authors performed an EMR review of all documented axillary arterial lines placed on PICU patients under age 18 between 2007 and 2023 at a tertiary hospital, yielding 306 patients.
These patients were age-matched with patients who received a radial arterial line during the same time period, for 306 controls.
The electronic notes were reviewed for demographic information, data relating to the line and its complications, and PICU mortality.
Analysis
The limitations imposed by the retrospective cohort study design make it challenging to directly compare the two techniques:
- The axillary arterial line is described as an 'alternative access site' chosen by the clinician when catheterisation of the radial artery was not possible.
- The axillary artery cohort was therefore not randomly chosen, and consists of sicker patients with more difficult arterial access
- The radial artery cohort was matched by similar age but otherwise randomly selected from the electronic record
The cohorts were clearly quite different at baseline, as demonstrated by the 12% mortality rate in the axillary group compared with 2% in the radial group. It is therefore difficult to make conclusions about the safety of one technique compared with the other, except to say that one might expect a higher rate of complications in the axillary artery cohort commensurate with their higher severity of illness.
The primary outcome was the rate of vascular complications in each cohort, which the authors defined as treatment or consult for vascular injury or thrombosis.
- One patient in the axillary artery group experienced a documented vascular complication (0.33%). This was described as an ischaemic upper limb, and was treated sucessfully with a brachial plexus nerve block, systemic tPA, and heparin infusion.
- No patients in the radial artery group experienced a vascular complication
Secondary outcomes included duration of catheter use, reasons for catheter removal and catheter replacement.
Axillary catheters were retained longer than radial (presumably relating to the difficulty in siting them in the first place!), and otherwise had similar removal and replacement rates.
Discussion
This paper has a somewhat narrow definition of a 'vascular complication', requiring that a patient underwent treatment or surgical assessment for thrombosis or arterial injury. These events are rare but clinically significant, and would be at the forefront of a clinician's mind when choosing their approach.
It is possible that other studies with a broader view of what constitutes a 'vascular complication' may uncover more subtle or transient differences between axillary and radial artery techniques, but a focus on the more devastating outcome seems reasonable given the axillary approach's second-line status.
Given the higher severity of illness in the axillary catheter group, the absence of an excess of severe vascular complications should reassure a clinician considering the axillary artery approach as a second-line option.
Take home message
The purpose of this paper is to help the clinician faced with an unwell paediatric patient with difficult arterial access, and provides some reassurance that an axillary arterial line is a feasible option in those challenging circumstances.
A key decision point for clinicians faced with impossible distal artery access in paediatrics might be to choose between upper and lower limb - with femoral being the more traditional choice. The comparative safety of femoral versus axillary arterial access is not examined by this paper, though a referenced single-centre study does show a lower incidence of vascular compromise (defined as 'any perfusion abnormality') for axillary versus femoral arterial lines in paediatric cardiac patients (6.2% vs 19.9%, respectively); the same paper described 4 major arterial injuries in the femoral group (0.37%, n=1068) and 0 in the axillary group (n=195).
While the findings are largely reassuring, this paper's description of management for the single ischaemic limb complication in the axillary group (and brief mention of retrograde cerebral embolism) serves to temper enthusiasm for more routine use of proximal artery techniques.
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