Consensus-Based Recommendations for Standardizing Terminology and Reporting Adverse Events for Emergency Department Procedural Sedation and Analgesia in Children

Bhatt, Maala; Kennedy, Robert M.; Osmond, Martin H.; Krauss, Baruch; McAllister, John D.; Ansermino, J. Mark; Evered, Lisa; Roback, Mark G.

doi:10.1016/j.annemergmed.2008.09.030

Cited by 191 publications

(146 citation statements)

References 57 publications

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“…Not surprisingly, some important milestones in pediatric research have emerged in PEM research networks; good examples of these are the US-based Pediatric Emergency Care Applied Research Network (PECARN) [ Recent examples of therapeutic progress include traumatic brain injuries, pediatric fractures, procedural sedation and analgesia, fever, bronchiolitis, diabetic ketoacidosis, and acute sickling episodes [2][3][4][5][6].…”

Section: Introductionmentioning

confidence: 99%

Ethics of Research in Pediatric Emergency Medicine

et al. 2014

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Clinical research in the pediatric emergency department (ED) has been rapidly growing in the past decade, and has resulted in some of the most important milestone studies in the pediatric medical literature. However, it presents a unique ethical goal and requires that additional challenges, such as the acute medical condition, fear and anxiety, unfamiliar physician(s), fatigue, and lack of time be addressed in addition to the standard ethical requirements. These may impair several fundamental elements of research, including the patient enrollment process, informed consent/assent, randomization, and others. Every possible attempt must be made to reduce or minimize the risks to which the children are exposed, and one must be cognizant of the special needs of children and their families in the ED. Nevertheless, we are also obliged to find ethical ways to include them in appropriate research endeavors that aim to improve treatments for conditions unique to the ED. This paper explores and overviews the most recent literature in order to characterize the nature of ethical challenges complicating clinical research in pediatric emergency medicine, and then suggests some ethically sound solutions such as deferred/waived consent, designated research staff, and alternative study designs. Finally, a few examples of prospective, blinded randomized trials involving drugs in pediatric emergency medicine are provided, with special emphasis on how the investigators are overcoming the obvious ethical challenges.

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Section: Introductionmentioning

confidence: 99%

Ethics of Research in Pediatric Emergency Medicine

et al. 2014

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“…[353][354][355][356][357][358][359] Therefore, each facility should maintain records that track all adverse events and significant interventions, such as desaturation; apnea; laryngospasm; need for airway interventions, including the need for placement of supraglottic devices such as an oral airway, nasal trumpet, or LMA; positivepressure ventilation; prolonged sedation; unanticipated use of reversal agents; unplanned or prolonged hospital admission; sedation failures; inability to complete the procedure; and unsatisfactory sedation, analgesia, or anxiolysis. 360 Such events can then be examined for the assessment of risk reduction and improvement in patient/family satisfaction.…”

Section: Continuous Quality Improvementmentioning

confidence: 99%

Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016

Coté¹,

Wilson²

2016

Pediatrics

253

199

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The safe sedation of children for procedures requires a systematic approach that includes the following: no administration of sedating medication without the safety net of medical/dental supervision, careful presedation evaluation for underlying medical or surgical conditions that would place the child at increased risk from sedating medications, appropriate fasting for elective procedures and a balance between the depth of sedation and risk for those who are unable to fast because of the urgent nature of the procedure, a focused airway examination for large (kissing) tonsils or anatomic airway abnormalities that might increase the potential for airway obstruction, a clear understanding of the medication's pharmacokinetic and pharmacodynamic effects and drug interactions, appropriate training and skills in airway management to allow rescue of the patient, age-and size-appropriate equipment for airway management and venous access, appropriate medications and reversal agents, suffi cient numbers of staff to both carry out the procedure and monitor the patient, appropriate physiologic monitoring during and after the procedure, a properly equipped and staffed recovery area, recovery to the presedation level of consciousness before discharge from medical/dental supervision, and appropriate discharge instructions. This report was developed through a collaborative effort of the

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“…Les publications récurrentes ont montré son efficacité et sa sécurité d'emploi par des urgentistes, aussi bien dans une population d'adultes que d'enfants [7,19,30]. Cependant, la surveillance des malades lors de SAP, le recueil des comorbidités et la décla-ration des effets secondaires devraient être standardisés [31]. Ce travail de standardisation qui a été réalisé en population pédiatrique pourrait servir de base pour les adultes [12].…”

Section: Discussionunclassified

Sédation avec le propofol dans un service d’urgences. Étude prospective observationnelle

Légaut

Roche

Chary

et al. 2010

Ann. Fr. Med. Urgence

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Introduction : La sédation-analgésie avant procé-dure douloureuse (SAP) est une avancée notable dans la prise en charge des urgences. Nous avons voulu décrire le mode d'utilisation du propofol dans notre structure d'urgences et comparer les résultats obtenus à ceux de la littérature internationale. Matériel et méthodes : Étude prospective observationnelle sur 44 mois de l'utilisation du propofol pour la SAP dans un service d'urgences adultes. Le propofol était injecté en bolus de 1 mg/kg, suivi éventuellement d'une titration jusqu'à l'obtention ou le maintien de l'effet sédatif désiré afin de permettre une procédure douloureuse. Tous les malades étaient étroitement surveillés en box d'urgences pendant au moins 30 minutes après la dernière injection. Résultats : En 44 mois, 115 malades ont eu une SAP par propofol, 111 dossiers sont exploitables, soit 69 hommes et 42 femmes d'âge moyen de 50 ± 21 ans (extrêmes : 18-94), de poids moyen 75 ± 15 kg (extrêmes : 48-140). La dose moyenne totale de propofol était de 113 ± 58 mg (extrêmes : 30-370). La dose moyenne par kilogramme de poids était de 1,50 ± 0,75 mg/kg (extrêmes : 0,5-5,6). Le geste pour lequel une SAP était indiquée a pu être effectué avec succès aux urgences dans 107/111 cas (97 %). Tous les patients étaient parfaitement réveillés et stables à 30 minutes. Les effets secondaires attendus, hypotension ou hypoventilation, ont tous été régressifs en quelques minutes. Il n'y a pas eu d'autres effets indésirables. Ces résultats sont comparables à ceux de la littérature. Conclusion : Le propofol répond efficacement aux besoins de SAP dans un service d'urgences en France comme il le fait ailleurs. Pour citer cette revue : Ann. Fr. Med. Urgence 1 (2011). Mots clés Propofol · Urgences · Sédation-analgésie · Procédure douloureuseAbstract Introduction: We describe the use of propofol for procedural sedation and analgesia (PSA) in a French adult Emergency Department (ED). We compare the results with those previously published. Materials and methods: A 44-month prospective observational study of the use of propofol in a French adult ED was conducted. Propofol was injected intravenously as a 1 mg/kg bolus, which could be followed by smaller aliquots if necessary. All patients were monitored for at least 30 minutes after the last injection. Results: Among the 115 patients who received propofol for PSA during the study period, 111 (69 males and 42 females) were completely evaluated. The mean age was 50 (SD: 21; range: 18-94), mean body weight was 75 kg (SD: 15; range: 48-140), mean total propofol dosing was 113 mg (SD: 58; range: 30-370), and mean propofol dosing per kg was 1.50 mg/kg (SD: 0.75; range: 0.5-5.6 mg/kg). The treatment was successful in 107/111 cases (97%). If hypotension or respiratory depression occurred, they were resolved in minutes. There were no cases of emesis, inhalation, or other side effects. These results compare favorably with those previously published. Conclusion: Propofol is a useful and safe tool for PSA in French EDs, as it is elsewhere. To cite...

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Consensus-Based Recommendations for Standardizing Terminology and Reporting Adverse Events for Emergency Department Procedural Sedation and Analgesia in Children

Cited by 191 publications

References 57 publications

Ethics of Research in Pediatric Emergency Medicine

Ethics of Research in Pediatric Emergency Medicine

Guidelines for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016

Sédation avec le propofol dans un service d’urgences. Étude prospective observationnelle

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