Evaluation of an updated sedation protocol to reduce benzodiazepines in a pediatric intensive care unit

Michel, Jörg; Hofbeck, Michael; Peper, Ann-Kathrin; Kumpf, Matthias; Neunhoeffer, Felix

doi:10.1080/03007995.2019.1663689

Cited by 7 publications

(26 citation statements)

References 34 publications

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“…The remaining six studies are observational cohort studies. Safety aspects were addressed as primary outcomes 14,29,34 or as secondary outcomes, when the priority of the studies was effectiveness of sedation or reduction of benzodiazepine doses 18,28,32 . Five of these studies characterised cohorts of clonidine patients without comparison groups.…”

Section: Study Selectionmentioning

confidence: 99%

“…In contrast, with the exception of Kleiber et al's 34 evaluation of the haemodynamic profile and tolerance, we considered an overall high risk for the remaining studies. 13,14,18,28,29,32,34,35 This was mostly due to the study design, particularly if only one cohort without comparison group was presented. We also found deficiencies in the definitions of the safety outcomes.…”

Section: Validity Of the Safety Outcomesmentioning

confidence: 99%

“…Another concordant outcome measure in five studies was the occurrence of withdrawal symptoms. 18,22,[29][30][31] Two studies identified an advantage of clonidine: After discontinuation of fentanyl and midazolam, Hünseler et al 31 reported fewer symptoms in the neonatal clonidine group compared to the neonatal midazolam group. Pohl-Schickinger et al 29 observed that withdrawal symptoms caused by F I G U R E 3 Risk of bias assessment according to the checklist of Faillie et al 27 for each included study; where necessary, the outcomes referred to are indicated: Bradycardia (i), hypotension (ii), mortality (iii), outcomes related to haemodynamics (iv), withdrawal symptoms (v), additional adverse events (vi).…”

Section: Summary Of Safety Issues Beside Haemodynamicsmentioning

confidence: 99%

“…In six included studies, 13,18,28,29,32,34 only cohorts of patients treated with clonidine without a comparison group were investigated and characterised. But since no data on the baseline risk of the safety outcomes were available, no reliable conclusions could be drawn about the impact of clonidine, especially not about the extent of adverse effects.…”

Section: A) Study Designmentioning

confidence: 99%

“…The off-label use of clonidine in PICUs has been widely established [13][14][15][16][17][18] and recently an increase in its utilization in PICUs has been described. [19][20][21] Thus, although there is an urgent need we did not identify any study that systematically and comprehensively reviewed the literature on the safety of clonidine in paediatric intensive care medicine.…”

Section: Introductionmentioning

confidence: 99%

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Safety of clonidine used for long‐term sedation in paediatric intensive care: A systematic review

Eberl

Ahne

Toni

et al. 2020

Brit J Clinical Pharma

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Aim Although not approved, the α‐adrenoceptor agonist clonidine is considered an option for long‐term sedation protocols in paediatric intensive care. We reviewed adverse effects of clonidine occurring in this indication. Methods Relevant literature was systematically identified from PubMed and Embase. We included interventional and observational studies on paediatric patients admitted to intensive care units and systemically long‐term sedated with clonidine‐containing regimes. In duplicates, we conducted standardised and independent full‐text assessment and extraction of safety data. Results Data from 11 studies with 909 patients were analysed. The studies were heterogeneous regarding patient characteristics (age groups, comorbidity, or comedication) and sedation regimes (dosage, route, duration, or concomitant sedatives). Just four randomised controlled trials (RCTs) and one observational study had comparison groups, using placebo or midazolam. For safety outcomes, our validity evaluation showed low risk of bias only in three studies. All studies focused on haemodynamic problems, particularly bradycardia and hypotension. Observed incidences or subsequent interventions never caused concerns. However, only two RCTs allowed meaningful comparisons with control groups. Odds ratios showed no significant difference between the groups, but small sample sizes (50 and 125 patients) must be considered; pooled analyses were not reasonable. Conclusion All evaluated studies concluded that the use of clonidine in paediatric intensive care units is safe. However, a valid characterisation of the safety profile remains challenging due to limited, biased and heterogeneous data and missing investigation of long‐term effects. This evaluation demonstrates the lack of data, which prevents reliable conclusions on the safety of clonidine for long‐term sedation in critically ill children. For an evidence‐based use, further studies are needed.

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Section: Study Selectionmentioning

confidence: 99%

Section: Validity Of the Safety Outcomesmentioning

confidence: 99%

Section: Summary Of Safety Issues Beside Haemodynamicsmentioning

confidence: 99%

Section: A) Study Designmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Safety of clonidine used for long‐term sedation in paediatric intensive care: A systematic review

Eberl

Ahne

Toni

et al. 2020

Brit J Clinical Pharma

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A Systematic Review and Pooled Prevalence of Delirium in Critically Ill Children*

Semple

Howlett

Strawbridge

et al. 2021

Critical Care Medicine

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Pediatric delirium is a neuropsychiatric disorder with disrupted cerebral functioning due to underlying disease and/or critical care treatment. Pediatric delirium can be classified as hypoactive, hyperactive, and mixed. This systematic review was conducted to estimate the pooled prevalence of pediatric delirium using validated assessment tools in children (Cornell Assessment of Pediatric Delirium, Pediatric Confusion Assessment Method for the ICU, PreSchool Confusion Assessment Method for the ICU, Pediatric Confusion Assessment Method for the ICU Severity Scale, and Sophia Observation Withdrawal Symptoms Pediatric Delirium scale), identify modifiable and nonmodifiable risk factors, and explore the association of pediatric delirium with clinical outcomes. DATA SOURCES:A systematic search of PubMed, EMBASE, and CINAHL databases was undertaken for full articles pertaining to pediatric delirium prevalence. STUDY SELECTION:No language or date barriers were set. Studies were included where the following eligibility criteria were met: study design aimed to estimate pediatric delirium prevalence arising from treatment in the intensive care setting, using a validated tool. Only randomized controlled trials, cross-sectional studies, or cohort studies allowing an estimate of the prevalence of pediatric delirium were included.DATA EXTRACTION: Data were extracted by the primary researcher (D.S.) and accuracy checked by coauthors. DATA SYNTHESIS:A narrative synthesis and pooled prevalence meta-analysis were undertaken. CONCLUSIONS:Pediatric delirium, as determined by the Cornell Assessment of Pediatric Delirium score, is estimated to occur in 34% of critical care admissions. Eight of 11 studies reporting on subtype identified hypoactive delirium as most prevalent (46-81%) with each of the three remaining reporting either hyperactive (44%), mixed (57%), or equal percentages of hypoactive and mixed delirium (43%) as most prevalent. The development of pediatric delirium is associated with cumulative doses of benzodiazepines, opioids, the number of sedative classes used, deep sedation, and cardiothoracic surgery. Increased time mechanically ventilated, length of stay, mortality, healthcare costs, and associations with decreased quality of life after discharge were also found. Multi-institutional and longitudinal studies are required to better determine the natural history, true prevalence, long-term outcomes, management strategies, and financial implications of pediatric delirium.

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Pain and sedation management and monitoring in pediatric intensive care units across Europe: an ESPNIC survey

et al. 2022

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Background Management and monitoring of pain and sedation to reduce discomfort as well as side effects, such as over- and under-sedation, withdrawal syndrome and delirium, is an integral part of pediatric intensive care practice. However, the current state of management and monitoring of analgosedation across European pediatric intensive care units (PICUs) remains unknown. The aim of this survey was to describe current practices across European PICUs regarding the management and monitoring of pain and sedation. Methods An online survey was distributed among 357 European PICUs assessing demographic features, drug choices and dosing, as well as usage of instruments for monitoring pain and sedation. We also compared low- and high-volume PICUs practices. Responses were collected from January to April 2021. Results A total of 215 (60% response rate) PICUs from 27 European countries responded. Seventy-one percent of PICUs stated to use protocols for analgosedation management, more frequently in high-volume PICUs (77% vs 63%, p = 0.028). First-choice drug combination was an opioid with a benzodiazepine, namely fentanyl (51%) and midazolam (71%) being the preferred drugs. The starting doses differed between PICUs from 0.1 to 5 mcg/kg/h for fentanyl, and 0.01 to 0.5 mg/kg/h for midazolam. Daily assessment and documentation for pain (81%) and sedation (87%) was reported by most of the PICUs, using the preferred validated FLACC scale (54%) and the COMFORT Behavioural scale (48%), respectively. Both analgesia and sedation were mainly monitored by nurses (92% and 84%, respectively). Eighty-six percent of the responding PICUs stated to use neuromuscular blocking agents in some scenarios. Monitoring of paralysed patients was preferably done by observation of vital signs with electronic devices support. Conclusions This survey provides an overview of current analgosedation practices among European PICUs. Drugs of choice, dosing and assessment strategies were shown to differ widely. Further research and development of evidence-based guidelines for optimal drug dosing and analgosedation assessment are needed.

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Evaluation of an updated sedation protocol to reduce benzodiazepines in a pediatric intensive care unit

Cited by 7 publications

References 34 publications

Safety of clonidine used for long‐term sedation in paediatric intensive care: A systematic review

Safety of clonidine used for long‐term sedation in paediatric intensive care: A systematic review

A Systematic Review and Pooled Prevalence of Delirium in Critically Ill Children*

Pain and sedation management and monitoring in pediatric intensive care units across Europe: an ESPNIC survey

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