OBJECTIVESWe aimed to describe the quality of sedation and additional clinically-meaningful outco... more OBJECTIVESWe aimed to describe the quality of sedation and additional clinically-meaningful outcomes associated with different intranasal dexmedetomidine-based regimens in children undergoing nonpainful procedures.METHODSA multicenter prospective observational study of children aged 2 months to 17 years undergoing intranasal dexmedetomidine sedation for MRI, auditory brainstem response testing, echocardiogram, EEG, or computed tomography scan. Regimens varied by dose of dexmedetomidine and use of adjunct sedatives. Quality of sedation was assessed using the Pediatric Sedation State Scale and by determining proportion of children who achieved an acceptable sedation state. Procedure completion, time-based outcomes, and adverse events were assessed.RESULTSWe enrolled 578 children across 7 sites. Median age was 2.5 years (interquartile range 1.6–3) and 37.5% were female. The most common procedures were auditory brainstem response testing (54.3%) and MRI (22.8%). The most common dose was...
ObjectivesWe aimed to develop a standardized scoring tool to measure point‐of‐care ultrasound (PO... more ObjectivesWe aimed to develop a standardized scoring tool to measure point‐of‐care ultrasound (POCUS) image quality and to determine validity evidence for its use to assess lung ultrasound image quality.MethodsThe POCUS Image Quality (POCUS IQ) scale was developed by POCUS‐trained physicians to assess sonographers' image acquisition skills by evaluating image quality for any POCUS application. The scale was piloted using lung images of healthy standardized patients acquired by three expert sonographers compared to three novices before and after training. All images (experts, novices pre‐training, novices post‐training) were scored on the POCUS IQ scale by three blinded POCUS‐trained physicians. Reliability was assessed with fully‐crossed generalizability and decision studies. Validity was assessed using Messick's framework.ResultsContent validity was supported by the tool's development process of literature review, expert consensus, and pilot testing. Response process wa...
BackgroundIntravenous ketorolac is commonly used for treating migraine headaches in children. How... more BackgroundIntravenous ketorolac is commonly used for treating migraine headaches in children. However, the prerequisite placement of an intravenous line can be technically challenging, time‐consuming, and associated with pain and distress. Intranasal ketorolac may be an effective alternative that is needle‐free and easier to administer. We aimed to determine whether intranasal ketorolac is non‐inferior to intravenous ketorolac for reducing pain in children with migraine headaches.MethodsWe conducted a randomized double‐blind non‐inferiority clinical trial. Children aged 8–17 years with migraine headaches, moderate to severe pain, and requiring parenteral analgesics received intranasal ketorolac (1 mg/kg) or intravenous ketorolac (0.5 mg/kg). Primary outcome was reduction in pain at 60 min after administration measured using the Faces Pain Scale‐Revised (scored 0–10). Non‐inferiority margin was 2/10. Secondary outcomes included time to onset of clinically meaningful decrease in pain;...
OBJECTIVES:Development and validation of the Pediatric Sedation State Scale (PSSS) is intended to... more OBJECTIVES:Development and validation of the Pediatric Sedation State Scale (PSSS) is intended to specifically meet the needs of pediatric procedural sedation providers to measure effectiveness and quality of care.METHODS:The PSSS content was developed through Delphi methods utilizing leading pediatric sedation experts and published guidelines on procedural sedation in children. Video clips were created and presented to study participants, who graded the state of patients during procedures by using the PSSS to evaluate inter- and intrarater reliability by determining the intraclass correlation coefficient. We also compared the PSSS to the Observational Scale of Behavioral Distress–revised during 4 clinically relevant phases of a laceration repair procedure.RESULTS:Six sedation states were defined for the PSSS. Each state was assigned a numerical value with higher numbers for increasing activity states. We included behaviors associated with adequate and inadequate sedation and advers...
The intranasal route is an effective means of administering sedatives and analgesics. It is a nee... more The intranasal route is an effective means of administering sedatives and analgesics. It is a needle-free alternative to intravenous or intramuscular routes, it is not subject to first-pass metabolism, and its efficacy approaches that of intravenous administration. There is absorption through the highly vascular nasal mucosa, as well as utilization of the nose–brain pathway that bypasses systemic circulation and the blood–brain barrier and transports medications directly to the brain. Intranasal administration of sedative and analgesic medications has been shown to be safe and effective for children in a variety of settings. It provides an opportunity to avoid intravenous line placement in many situations, which may reduce the pain and anxiety associated with many diagnostic and therapeutic procedures in children. More studies are needed to compare important sedation outcomes between intranasal sedation regimens and the more common intravenous sedation regimens in order to guide bes...
Objective Distraction can reduce pain and distress associated with painful procedures but has nev... more Objective Distraction can reduce pain and distress associated with painful procedures but has never been studied in children with solid organ transplants. We aimed to determine whether there is a difference in pain and distress associated with venipuncture in pediatric posttransplant patients who receive distraction compared with those who do not. Methods Randomized controlled trial of children aged 4 to 17 years with solid organ transplants undergoing venipuncture in the outpatient setting. Patients were randomized to receive distraction or no distraction. The primary outcome was the Faces Pain Scale–Revised. Secondary outcomes were the Observational Scale of Behavioral Distress–Revised; Faces, Leg, Activity, Cry, Consolability; and Children's Hospital of Eastern Ontario Pain Scale. Exploratory outcomes included the number of venipuncture attempts, time to successful venipuncture, and satisfaction of phlebotomists and parents. Results Median age of the 40 children enrolled was 11.5 years. Type of transplants included the heart (67.5%), kidney (22.5%), liver (7.5%), and more than 1 organ (2.5%). There was no difference between the Faces Pain Scale–Revised scores in distraction and no distraction groups (1.4; 95% confidence interval, 0.9–1.9; and 1.3, 95% confidence interval, 0.5–2.1, respectively). There was also no difference in the Observational Scale of Behavioral Distress–Revised; Faces, Leg, Activity, Cry, Consolability; and Children's Hospital of Eastern Ontario Pain Scale scores, number of venipuncture attempts, or time to successful venipuncture. Phlebotomists were more satisfied with the venipuncture when distraction was implemented. Conclusions In children with solid organ transplants, there was no difference in pain and distress associated with venipuncture between those who did and did not receive distraction. There was also no difference in other procedure-related outcomes except for greater phlebotomist satisfaction when distraction was implemented.
OBJECTIVES To identify self-reported pain scores that best represent categories of no pain, mild,... more OBJECTIVES To identify self-reported pain scores that best represent categories of no pain, mild, moderate, and severe pain in children, and a pain score that accurately represents a child's perceived need for medication (PNM), i.e. a minimum pain score at which a child would want an analgesic. STUDY DESIGN Prospective cross-sectional cohort study of children aged 6-17 years presenting to a pediatric emergency department with painful and non-painful conditions. Pain was measured using the Verbal Numerical Rating Scale. Receiver operating characteristic-based methodology was used to determine pain scores that best differentiated no pain from mild, mild from moderate, and moderate from severe pain. Descriptive statistics were used to determine the PNM. RESULTS We analyzed data from 548 children (51.3% female, 61.9% painful conditions). The scores that best represent categories of pain intensity are: 0-1 (no pain), 2-5 (mild), 6-7 (moderate), and 8-10 (severe) out of 10. The area under the curve for the cut points differentiating each category ranged from 0.76 to 0.88. The median pain score representing PNM was 6 (IQR 4, 7; range 0-10) out of 10. CONCLUSIONS We identified population-level self-reported pain scores in children associated with categories of pain intensity that differ from those conventionally used. Implementing our findings may provide a more accurate representation of the clinical meaning of pain scores and reduce selection bias in research. Our findings do not support the use of pain scores in isolation for clinical decision making or use of a pain score threshold to represent a child's PNM.
BackgroundClinicians appear to obtain emergent neuroimaging for children with headaches based on ... more BackgroundClinicians appear to obtain emergent neuroimaging for children with headaches based on the presence of red flag findings. However, little data exists regarding the prevalence of these findings in emergency department populations, and whether the identification of red flag findings is associated with potentially unnecessary emergency department neuroimaging.ObjectivesWe aimed to determine the prevalence of red flag findings and their association with neuroimaging in otherwise healthy children presenting with headaches to the emergency department. Our secondary aim was to determine the prevalence of emergent intracranial abnormalities in this population.MethodsA prospective cohort study of otherwise healthy children 2–17 years of age presenting to an urban pediatric emergency department with non-traumatic headaches was undertaken. Emergency department physicians completed a standardized form to document headache descriptors and characteristics, associated symptoms, and physi...
Appropriate pain measurement relies on the use of valid, reliable tools. The aim of this study wa... more Appropriate pain measurement relies on the use of valid, reliable tools. The aim of this study was to determine and compare the psychometric properties of 3 self-reported pain scales commonly used in the pediatric emergency department (ED). The inclusion criteria were children aged 6 to 17 years presenting to the ED with a musculoskeletal injury and self-reported pain scores ≥30 mm on the mechanical Visual Analogue Scale (VAS). Self-reported pain intensity was assessed using the mechanical VAS, Faces Pain Scale-Revised (FPS-R), and Colour Analogue Scale (CAS). Convergent validity was assessed by Pearson correlations and the Bland-Altman method; responsiveness to change was assessed using paired sample t tests and standardized mean responses; and reliability was estimated using relative and absolute indices. A total of 456 participants were included, with a mean age of 11.9 years ± 2.7 and a majority were boys (252/456, 55.3%). Correlations between each pair of scales were 0.78 (VAS/...
The Verbal Numerical Rating Scale is the most commonly used self-report measure of pain intensity... more The Verbal Numerical Rating Scale is the most commonly used self-report measure of pain intensity. It is unclear how the validity and reliability of the scale scores vary across children's ages. We aimed to determine the validity and reliability of the scale for children presenting to the emergency department across a comprehensive spectrum of age. This was a cross-sectional study of children aged 4 to 17 years. Children self-reported their pain intensity, using the Verbal Numerical Rating Scale and Faces Pain Scale-Revised at 2 serial assessments. We evaluated convergent validity (strong validity defined as correlation coefficient ≥0.60), agreement (difference between concurrent Verbal Numerical Rating Scale and Faces Pain Scale-Revised scores), known-groups validity (difference in score between children with painful versus nonpainful conditions), responsivity (decrease in score after analgesic administration), and reliability (test-retest at 2 serial assessments) in the total ...
The aims of this study were to define the Faces Pain Scale-Revised (FPS-R) and Color Analog Scale... more The aims of this study were to define the Faces Pain Scale-Revised (FPS-R) and Color Analog Scale (CAS) scores associated with no pain, mild pain, moderate pain, and severe pain in children with acute pain, and to identify differences based on age, sex, and ethnicity. We conducted a prospective observational study in 2 pediatric emergency departments of children aged 4 to 17 years with painful and nonpainful conditions. We assessed their pain intensity using the FPS-R, CAS, and qualitative measures. Pain score cut points that best differentiated adjacent categories of pain were identified using a receiver operating characteristic-based method. Cut points were compared within subgroups based on age, sex, and ethnicity. We enrolled 620 patients, of whom 314 had painful conditions. The mean age was 9.2 years; 315 (50.8%) were in the younger age group (aged 4-7 years); 291 (46.8%) were female; and 341 (55%) were Hispanic. The scores best representing categories of pain for the FPS-R wer...
To describe practice patterns and adverse events associated with nitrous oxide (N2O) administrati... more To describe practice patterns and adverse events associated with nitrous oxide (N2O) administration as the primary sedative outside the operating room in varied settings by a diverse range of providers, and to identify patient and sedation characteristics associated with adverse events. Data prospectively collected by the Pediatric Sedation Research Consortium, which is comprised of 40 children's and general/community hospitals, was retrospectively analyzed for children who received N2O as the primary sedative. Descriptive measures of patient and sedation characteristics and adverse events were reported. A multivariable regression model was used to assess potential associations between patient and sedation characteristics and adverse events. A total of 1634 N2O administrations were identified. The majority was performed in sedation units, and most by advanced practice nurses or physician assistants. The most common adjunct medication was midazolam. There was a low prevalence of ...
OBJECTIVESWe aimed to describe the quality of sedation and additional clinically-meaningful outco... more OBJECTIVESWe aimed to describe the quality of sedation and additional clinically-meaningful outcomes associated with different intranasal dexmedetomidine-based regimens in children undergoing nonpainful procedures.METHODSA multicenter prospective observational study of children aged 2 months to 17 years undergoing intranasal dexmedetomidine sedation for MRI, auditory brainstem response testing, echocardiogram, EEG, or computed tomography scan. Regimens varied by dose of dexmedetomidine and use of adjunct sedatives. Quality of sedation was assessed using the Pediatric Sedation State Scale and by determining proportion of children who achieved an acceptable sedation state. Procedure completion, time-based outcomes, and adverse events were assessed.RESULTSWe enrolled 578 children across 7 sites. Median age was 2.5 years (interquartile range 1.6–3) and 37.5% were female. The most common procedures were auditory brainstem response testing (54.3%) and MRI (22.8%). The most common dose was...
ObjectivesWe aimed to develop a standardized scoring tool to measure point‐of‐care ultrasound (PO... more ObjectivesWe aimed to develop a standardized scoring tool to measure point‐of‐care ultrasound (POCUS) image quality and to determine validity evidence for its use to assess lung ultrasound image quality.MethodsThe POCUS Image Quality (POCUS IQ) scale was developed by POCUS‐trained physicians to assess sonographers' image acquisition skills by evaluating image quality for any POCUS application. The scale was piloted using lung images of healthy standardized patients acquired by three expert sonographers compared to three novices before and after training. All images (experts, novices pre‐training, novices post‐training) were scored on the POCUS IQ scale by three blinded POCUS‐trained physicians. Reliability was assessed with fully‐crossed generalizability and decision studies. Validity was assessed using Messick's framework.ResultsContent validity was supported by the tool's development process of literature review, expert consensus, and pilot testing. Response process wa...
BackgroundIntravenous ketorolac is commonly used for treating migraine headaches in children. How... more BackgroundIntravenous ketorolac is commonly used for treating migraine headaches in children. However, the prerequisite placement of an intravenous line can be technically challenging, time‐consuming, and associated with pain and distress. Intranasal ketorolac may be an effective alternative that is needle‐free and easier to administer. We aimed to determine whether intranasal ketorolac is non‐inferior to intravenous ketorolac for reducing pain in children with migraine headaches.MethodsWe conducted a randomized double‐blind non‐inferiority clinical trial. Children aged 8–17 years with migraine headaches, moderate to severe pain, and requiring parenteral analgesics received intranasal ketorolac (1 mg/kg) or intravenous ketorolac (0.5 mg/kg). Primary outcome was reduction in pain at 60 min after administration measured using the Faces Pain Scale‐Revised (scored 0–10). Non‐inferiority margin was 2/10. Secondary outcomes included time to onset of clinically meaningful decrease in pain;...
OBJECTIVES:Development and validation of the Pediatric Sedation State Scale (PSSS) is intended to... more OBJECTIVES:Development and validation of the Pediatric Sedation State Scale (PSSS) is intended to specifically meet the needs of pediatric procedural sedation providers to measure effectiveness and quality of care.METHODS:The PSSS content was developed through Delphi methods utilizing leading pediatric sedation experts and published guidelines on procedural sedation in children. Video clips were created and presented to study participants, who graded the state of patients during procedures by using the PSSS to evaluate inter- and intrarater reliability by determining the intraclass correlation coefficient. We also compared the PSSS to the Observational Scale of Behavioral Distress–revised during 4 clinically relevant phases of a laceration repair procedure.RESULTS:Six sedation states were defined for the PSSS. Each state was assigned a numerical value with higher numbers for increasing activity states. We included behaviors associated with adequate and inadequate sedation and advers...
The intranasal route is an effective means of administering sedatives and analgesics. It is a nee... more The intranasal route is an effective means of administering sedatives and analgesics. It is a needle-free alternative to intravenous or intramuscular routes, it is not subject to first-pass metabolism, and its efficacy approaches that of intravenous administration. There is absorption through the highly vascular nasal mucosa, as well as utilization of the nose–brain pathway that bypasses systemic circulation and the blood–brain barrier and transports medications directly to the brain. Intranasal administration of sedative and analgesic medications has been shown to be safe and effective for children in a variety of settings. It provides an opportunity to avoid intravenous line placement in many situations, which may reduce the pain and anxiety associated with many diagnostic and therapeutic procedures in children. More studies are needed to compare important sedation outcomes between intranasal sedation regimens and the more common intravenous sedation regimens in order to guide bes...
Objective Distraction can reduce pain and distress associated with painful procedures but has nev... more Objective Distraction can reduce pain and distress associated with painful procedures but has never been studied in children with solid organ transplants. We aimed to determine whether there is a difference in pain and distress associated with venipuncture in pediatric posttransplant patients who receive distraction compared with those who do not. Methods Randomized controlled trial of children aged 4 to 17 years with solid organ transplants undergoing venipuncture in the outpatient setting. Patients were randomized to receive distraction or no distraction. The primary outcome was the Faces Pain Scale–Revised. Secondary outcomes were the Observational Scale of Behavioral Distress–Revised; Faces, Leg, Activity, Cry, Consolability; and Children's Hospital of Eastern Ontario Pain Scale. Exploratory outcomes included the number of venipuncture attempts, time to successful venipuncture, and satisfaction of phlebotomists and parents. Results Median age of the 40 children enrolled was 11.5 years. Type of transplants included the heart (67.5%), kidney (22.5%), liver (7.5%), and more than 1 organ (2.5%). There was no difference between the Faces Pain Scale–Revised scores in distraction and no distraction groups (1.4; 95% confidence interval, 0.9–1.9; and 1.3, 95% confidence interval, 0.5–2.1, respectively). There was also no difference in the Observational Scale of Behavioral Distress–Revised; Faces, Leg, Activity, Cry, Consolability; and Children's Hospital of Eastern Ontario Pain Scale scores, number of venipuncture attempts, or time to successful venipuncture. Phlebotomists were more satisfied with the venipuncture when distraction was implemented. Conclusions In children with solid organ transplants, there was no difference in pain and distress associated with venipuncture between those who did and did not receive distraction. There was also no difference in other procedure-related outcomes except for greater phlebotomist satisfaction when distraction was implemented.
OBJECTIVES To identify self-reported pain scores that best represent categories of no pain, mild,... more OBJECTIVES To identify self-reported pain scores that best represent categories of no pain, mild, moderate, and severe pain in children, and a pain score that accurately represents a child's perceived need for medication (PNM), i.e. a minimum pain score at which a child would want an analgesic. STUDY DESIGN Prospective cross-sectional cohort study of children aged 6-17 years presenting to a pediatric emergency department with painful and non-painful conditions. Pain was measured using the Verbal Numerical Rating Scale. Receiver operating characteristic-based methodology was used to determine pain scores that best differentiated no pain from mild, mild from moderate, and moderate from severe pain. Descriptive statistics were used to determine the PNM. RESULTS We analyzed data from 548 children (51.3% female, 61.9% painful conditions). The scores that best represent categories of pain intensity are: 0-1 (no pain), 2-5 (mild), 6-7 (moderate), and 8-10 (severe) out of 10. The area under the curve for the cut points differentiating each category ranged from 0.76 to 0.88. The median pain score representing PNM was 6 (IQR 4, 7; range 0-10) out of 10. CONCLUSIONS We identified population-level self-reported pain scores in children associated with categories of pain intensity that differ from those conventionally used. Implementing our findings may provide a more accurate representation of the clinical meaning of pain scores and reduce selection bias in research. Our findings do not support the use of pain scores in isolation for clinical decision making or use of a pain score threshold to represent a child's PNM.
BackgroundClinicians appear to obtain emergent neuroimaging for children with headaches based on ... more BackgroundClinicians appear to obtain emergent neuroimaging for children with headaches based on the presence of red flag findings. However, little data exists regarding the prevalence of these findings in emergency department populations, and whether the identification of red flag findings is associated with potentially unnecessary emergency department neuroimaging.ObjectivesWe aimed to determine the prevalence of red flag findings and their association with neuroimaging in otherwise healthy children presenting with headaches to the emergency department. Our secondary aim was to determine the prevalence of emergent intracranial abnormalities in this population.MethodsA prospective cohort study of otherwise healthy children 2–17 years of age presenting to an urban pediatric emergency department with non-traumatic headaches was undertaken. Emergency department physicians completed a standardized form to document headache descriptors and characteristics, associated symptoms, and physi...
Appropriate pain measurement relies on the use of valid, reliable tools. The aim of this study wa... more Appropriate pain measurement relies on the use of valid, reliable tools. The aim of this study was to determine and compare the psychometric properties of 3 self-reported pain scales commonly used in the pediatric emergency department (ED). The inclusion criteria were children aged 6 to 17 years presenting to the ED with a musculoskeletal injury and self-reported pain scores ≥30 mm on the mechanical Visual Analogue Scale (VAS). Self-reported pain intensity was assessed using the mechanical VAS, Faces Pain Scale-Revised (FPS-R), and Colour Analogue Scale (CAS). Convergent validity was assessed by Pearson correlations and the Bland-Altman method; responsiveness to change was assessed using paired sample t tests and standardized mean responses; and reliability was estimated using relative and absolute indices. A total of 456 participants were included, with a mean age of 11.9 years ± 2.7 and a majority were boys (252/456, 55.3%). Correlations between each pair of scales were 0.78 (VAS/...
The Verbal Numerical Rating Scale is the most commonly used self-report measure of pain intensity... more The Verbal Numerical Rating Scale is the most commonly used self-report measure of pain intensity. It is unclear how the validity and reliability of the scale scores vary across children's ages. We aimed to determine the validity and reliability of the scale for children presenting to the emergency department across a comprehensive spectrum of age. This was a cross-sectional study of children aged 4 to 17 years. Children self-reported their pain intensity, using the Verbal Numerical Rating Scale and Faces Pain Scale-Revised at 2 serial assessments. We evaluated convergent validity (strong validity defined as correlation coefficient ≥0.60), agreement (difference between concurrent Verbal Numerical Rating Scale and Faces Pain Scale-Revised scores), known-groups validity (difference in score between children with painful versus nonpainful conditions), responsivity (decrease in score after analgesic administration), and reliability (test-retest at 2 serial assessments) in the total ...
The aims of this study were to define the Faces Pain Scale-Revised (FPS-R) and Color Analog Scale... more The aims of this study were to define the Faces Pain Scale-Revised (FPS-R) and Color Analog Scale (CAS) scores associated with no pain, mild pain, moderate pain, and severe pain in children with acute pain, and to identify differences based on age, sex, and ethnicity. We conducted a prospective observational study in 2 pediatric emergency departments of children aged 4 to 17 years with painful and nonpainful conditions. We assessed their pain intensity using the FPS-R, CAS, and qualitative measures. Pain score cut points that best differentiated adjacent categories of pain were identified using a receiver operating characteristic-based method. Cut points were compared within subgroups based on age, sex, and ethnicity. We enrolled 620 patients, of whom 314 had painful conditions. The mean age was 9.2 years; 315 (50.8%) were in the younger age group (aged 4-7 years); 291 (46.8%) were female; and 341 (55%) were Hispanic. The scores best representing categories of pain for the FPS-R wer...
To describe practice patterns and adverse events associated with nitrous oxide (N2O) administrati... more To describe practice patterns and adverse events associated with nitrous oxide (N2O) administration as the primary sedative outside the operating room in varied settings by a diverse range of providers, and to identify patient and sedation characteristics associated with adverse events. Data prospectively collected by the Pediatric Sedation Research Consortium, which is comprised of 40 children's and general/community hospitals, was retrospectively analyzed for children who received N2O as the primary sedative. Descriptive measures of patient and sedation characteristics and adverse events were reported. A multivariable regression model was used to assess potential associations between patient and sedation characteristics and adverse events. A total of 1634 N2O administrations were identified. The majority was performed in sedation units, and most by advanced practice nurses or physician assistants. The most common adjunct medication was midazolam. There was a low prevalence of ...
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