Sarah Curtis

Bio: Sarah Curtis is an academic researcher from University of Alberta. The author has contributed to research in topics: Randomized controlled trial & Emergency department. The author has an hindex of 17, co-authored 46 publications receiving 1135 citations.

Standard 6: Age Groups for Pediatric Trials

Abstract: * Abbreviations: RCT — : randomized controlled trial SSRI — : selective serotonin reuptake inhibitor It has long been an axiom in clinical pediatrics that “children are not just little adults.” It has also been recognized that there are many changes from birth through childhood and the adolescent years. However, the full implications of pediatric age groupings for health care and research are still not adequately understood. There is still much to be discovered about children’s biological and psychological development and how these processes affect the effectiveness and efficacy of interventions. Trial design that accounts for age differences and promotes consistency in reporting of age-related data is essential to ensure the validity and clinical usefulness of pediatric trial data. A recent study highlighted variable treatment efficacy in children versus adults. In this study, 128 meta-analyses from Cochrane reviews, containing data on at least 1 adult and 1 pediatric randomized controlled trial (RCT) with a binary primary efficacy outcome, were reviewed.1 The authors found that in all except 1 case, the 95% confidence intervals could not exclude a relative difference in treatment efficacy between adults and children of >20%; in two-thirds of these cases, the relative difference in observed point estimates was >50%. The study also highlighted the paucity of RCTs in pediatrics; the median number of children per meta-analysis was 2.5 times smaller than the number of adults. Children and adults seem to have distinctive responses to treatments. For example, administration of phenobarbitones is useful for adults with cerebral malaria and is associated with decreased convulsions. However, in children, this drug is associated with increased 6-month mortality. Similarly, corticosteroids may offer survival benefit for adults with bacterial meningitis but not for children with the same condition. In acute traumatic brain injury, corticosteroids did not decrease mortality in adults, but there was a trend for increased mortality in children.1 In asthma, long-acting β2-agonists decreased … Address correspondence to Martin Offringa, MD, PhD, Senior Scientist and Program Head, Child Health Evaluative Sciences, Research Institute, The Hospital for Sick Children, 555 University Ave, Toronto, Ontario, Canada M5G 1X8. E-mail: martin.offringa{at}sickkids.ca

Clinical Features Suggestive of Meningitis in Children: A Systematic Review of Prospective Data

Abstract: CONTEXT: Clinical diagnosis of pediatric meningitis is fundamental; therefore, familiarity with evidence underscoring clinical features suggestive of meningitis is important. OBJECTIVE: To seek evidence supporting accuracy of clinical features of pediatric bacterial meningitis. METHODS: A review of Medline, Embase, the Cumulative Index to Nursing and Allied Health Literature, Web of Science, and PubMed was conducted for all articles of relevance. Articles contained prospective data of clinical features in children with laboratory-confirmed bacterial meningitis and in comparison groups of those without it. Two authors independently assessed quality and extracted data to calculate accuracy data of clinical features. RESULTS: Of 14 145 references initially identified, 10 met our inclusion criteria. On history, a report of bulging fontanel (likelihood ratio [LR]: 8.00 [95% confidence interval (CI): 2.4–26]), neck stiffness (7.70 [3.2–19]), seizures (outside febrile-convulsion age range) (4.40 [3.0–6.4]), or reduced feeds (2.00 [1.2–3.4]) raised concern about the presence of meningitis. On examination, jaundice (LR: 5.90 [95% CI: 1.8–19]), being toxic or moribund (5.80 [3.0–11]), meningeal signs (4.50 [2.4–8.3]), neck stiffness (4.00 [2.6–6.3]), bulging fontanel (3.50 [2.0–6.0]), Kernig sign (3.50 [2.1–5.7]), tone up (3.20 [2.2–4.5]), fever of >40°C (2.90 [1.6–5.5]), and Brudzinski sign (2.50 [1.8–3.6]) independently raised the likelihood of meningitis. The absence of meningeal signs (LR: 0.41 [95% CI: 0.30–0.57]) and an abnormal cry (0.30 [0.16–0.57]) independently lowered the likelihood of meningitis. The absence of fever did not rule out meningitis (LR: 0.70 [95% CI: 0.53–0.92]). CONCLUSIONS: Evidence for several useful clinical features that influence the likelihood of pediatric meningitis exists. No isolated clinical feature is diagnostic, and the most accurate diagnostic combination is unclear.

Music to Reduce Pain and Distress in the Pediatric Emergency Department: A Randomized Clinical Trial

Abstract: Importance Many medical procedures aimed at helping children cause them pain and distress, which can have long-lasting negative effects. Music is a form of distraction that may alleviate some of the pain and distress experienced by children while undergoing medical procedures. Objective To compare music with standard care to manage pain and distress. Design, Setting, and Participants Randomized clinical trial conducted in a pediatric emergency department with appropriate sequence generation and adequate allocation concealment from January 1, 2009, to March 31, 2010. Individuals assessing the primary outcome were blind to treatment allocation. A total of 42 children aged 3 to 11 years undergoing intravenous placement were included. Interventions Music (recordings selected by a music therapist via ambient speakers) vs standard care. Main Outcomes and Measures The primary outcome was behavioral distress assessed blinded using the Observational Scale of Behavioral Distress–Revised. The secondary outcomes included child-reported pain, heart rate, parent and health care provider satisfaction, ease of performing the procedure, and parental anxiety. Results With or without controlling for potential confounders, we found no significant difference in the change in behavioral distress from before the procedure to immediately after the procedure. When children who had no distress during the procedure were removed from the analysis, there was a significantly less increase in distress for the music group (standard care group = 2.2 vs music group = 1.1, P P = .04); the difference was considered clinically important. The pattern of parent satisfaction with the management of children’s pain was different between groups, although not statistically significant ( P = .07). Health care providers reported that it was easier to perform the procedure for children in the music group (76% very easy) vs the standard care group (38% very easy) ( P = .03). Health care providers were more satisfied with the intravenous placement in the music group (86% very satisfied) compared with the standard care group (48%) ( P = .02). Conclusions and Relevance Music may have a positive impact on pain and distress for children undergoing intravenous placement. Benefits were also observed for the parents and health care providers. Trial Registration clinicaltrials.gov Identifier:NCT00761033

A randomized controlled trial of sucrose and/or pacifier as analgesia for infants receiving venipuncture in a pediatric emergency department

Abstract: Although sucrose has been accepted as an effective analgesic agent for procedural pain in neonates, previous studies are largely in the NICU population using the procedure of heel lance. This is the first report of the effect of sucrose, pacifier or the combination thereof for the procedural pain of venipuncture in infants in the pediatric emergency department population. The study design was a double (sucrose) and single blind (pacifier), placebo-controlled randomized trial – factorial design carried out in a pediatric emergency department. The study population was infants, aged 0 – 6 months. Eighty-four patients were randomly assigned to one of four groups: a) sucrose b) sucrose & pacifier c) control d) control & pacifier. Each child received 2 ml of either 44% sucrose or sterile water, by mouth. The primary outcome measure: FLACC pain scale score change from baseline. Secondary outcome measures: crying time and heart rate change from baseline. Sucrose did not significantly reduce the FLACC score, crying time or heart rate. However sub-group analysis revealed that sucrose had a much greater effect in the younger groups. Pacifier use reduced FLACC score (not statistically significant), crying times (statistically significant) but not heart rate. Subgroup analysis revealed a mean crying time difference of 76.52 seconds (p 3 months pacifier did not have any significant effect on crying time. Age adjusted regression analysis revealed that both sucrose and pacifier had significant effects on crying time. Crying time increased with both increasing age and increasing gestational age. Pacifiers are inexpensive, effective analgesics and are easy to use in the PED for venipuncture in infants aged 0–3 months. The benefits of sucrose alone as an analgesic require further investigation in the older infant, but sucrose does appear to provide additional benefit when used with a pacifier in this age group. Current Controlled Trials ISRCTN15819627

Child and adolescent mental health worldwide: evidence for action

Abstract: This article suggests that while mental health problems affect 10—20% of children and adolescents worldwide, the mental health needs of children and adolescents are neglected, especially in low-income and middle-income countries. The authors review the evidence and the gaps in the published work in terms of prevalence, risk and protective factors, and interventions to prevent and treat childhood and adolescent mental health problems.

Sucrose for analgesia in newborn infants undergoing painful procedures

Abstract: Background Administration of oral sucrose with and without non-nutritive sucking is the most frequently studied non-pharmacological intervention for procedural pain relief in neonates. Objectives To determine the efficacy, effect of dose, method of administration and safety of sucrose for relieving procedural pain in neonates as assessed by validated composite pain scores, physiological pain indicators (heart rate, respiratory rate, saturation of peripheral oxygen in the blood, transcutaneous oxygen and carbon dioxide (gas exchange measured across the skin - TcpO2, TcpCO2), near infrared spectroscopy (NIRS), electroencephalogram (EEG), or behavioural pain indicators (cry duration, proportion of time crying, proportion of time facial actions (e.g. grimace) are present), or a combination of these and long-term neurodevelopmental outcomes. Search methods We used the standard methods of the Cochrane Neonatal. We performed electronic and manual literature searches in February 2016 for published randomised controlled trials (RCTs) in the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library, Issue 1, 2016), MEDLINE (1950 to 2016), EMBASE (1980 to 2016), and CINAHL (1982 to 2016). We did not impose language restrictions. Selection criteria RCTs in which term or preterm neonates (postnatal age maximum of 28 days after reaching 40 weeks' postmenstrual age), or both, received sucrose for procedural pain. Control interventions included no treatment, water, glucose, breast milk, breastfeeding, local anaesthetic, pacifier, positioning/containing or acupuncture. Data collection and analysis Our main outcome measures were composite pain scores (including a combination of behavioural, physiological and contextual indicators). Secondary outcomes included separate physiological and behavioural pain indicators. We reported a mean difference (MD) or weighted MD (WMD) with 95% confidence intervals (CI) using the fixed-effect model for continuous outcome measures. For categorical data we used risk ratio (RR) and risk difference. We assessed heterogeneity by the I2 test. We assessed the risk of bias of included trials using the Cochrane 'Risk of bias' tool, and assessed the quality of the evidence using the GRADE system. Main results Seventy-four studies enrolling 7049 infants were included. Results from only a few studies could be combined in meta-analyses and for most analyses the GRADE assessments indicated low- or moderate-quality evidence. There was high-quality evidence for the beneficial effect of sucrose (24%) with non-nutritive sucking (pacifier dipped in sucrose) or 0.5 mL of sucrose orally in preterm and term infants: Premature Infant Pain Profile (PIPP) 30 s after heel lance WMD -1.70 (95% CI -2.13 to -1.26; I2 = 0% (no heterogeneity); 3 studies, n = 278); PIPP 60 s after heel lance WMD -2.14 (95% CI -3.34 to -0.94; I2 = 0% (no heterogeneity; 2 studies, n = 164). There was high-quality evidence for the use of 2 mL 24% sucrose prior to venipuncture: PIPP during venipuncture WMD -2.79 (95% CI -3.76 to -1.83; I2 = 0% (no heterogeneity; 2 groups in 1 study, n = 213); and intramuscular injections: PIPP during intramuscular injection WMD -1.05 (95% CI -1.98 to -0.12; I2 = 0% (2 groups in 1 study, n = 232). Evidence from studies that could not be included in RevMan-analyses supported these findings. Reported adverse effects were minor and similar in the sucrose and control groups. Sucrose is not effective in reducing pain from circumcision. The effectiveness of sucrose for reducing pain/stress from other interventions such as arterial puncture, subcutaneous injection, insertion of nasogastric or orogastric tubes, bladder catherization, eye examinations and echocardiography examinations are inconclusive. Most trials indicated some benefit of sucrose use but that the evidence for other painful procedures is of lower quality as it is based on few studies of small sample sizes. The effects of sucrose on long-term neurodevelopmental outcomes are unknown. Authors' conclusions Sucrose is effective for reducing procedural pain from single events such as heel lance, venipuncture and intramuscular injection in both preterm and term infants. No serious side effects or harms have been documented with this intervention. We could not identify an optimal dose due to inconsistency in effective sucrose dosage among studies. Further investigation of repeated administration of sucrose in neonates is needed. There is some moderate-quality evidence that sucrose in combination with other non-pharmacological interventions such as non-nutritive sucking is more effective than sucrose alone, but more research of this and sucrose in combination with pharmacological interventions is needed. Sucrose use in extremely preterm, unstable, ventilated (or a combination of these) neonates needs to be addressed. Additional research is needed to determine the minimally effective dose of sucrose during a single painful procedure and the effect of repeated sucrose administration on immediate (pain intensity) and long-term (neurodevelopmental) outcomes.

Psychological interventions for needle‐related procedural pain and distress in children and adolescents

Abstract: Background This review is an updated version of the original Cochrane review published in Issue 4, 2006. Needle-related procedures are a common source of pain and distress for children. Our previous review on this topic indicated that a number of psychological interventions were efficacious in managing pediatric needle pain, including distraction, hypnosis, and combined cognitive behavioural interventions. Considerable additional research in the area has been published since that time. Objectives To provide an update to our 2006 review assessing the efficacy of psychological interventions for needle-related procedural pain and distress in children and adolescents. Search methods Searches of the following databases were conducted for relevant randomized controlled trials (RCTs): Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE; EMBASE; PsycINFO; the Cumulative Index to Nursing and Allied Health Literature (CINAHL); and Web of Science. Requests for relevant studies were also posted on various electronic list servers. We ran an updated search in March 2012, and again in March 2013. Selection criteria Participants included children and adolescents aged two to 19 years undergoing needle-related procedures. Only RCTs with at least five participants in each study arm comparing a psychological intervention group with a control or comparison group were eligible for inclusion. Data collection and analysis Two review authors extracted data and assessed trial quality and a third author helped with data extraction and coding for one non-English study. Included studies were coded for quality using the Cochrane Risk of bias tool. Standardized mean differences with 95% confidence intervals were computed for all analyses using Review Manager 5.2 software. Main results Thirty-nine trials with 3394 participants were included. The most commonly studied needle procedures were venipuncture, intravenous (IV) line insertion, and immunization. Studies included children aged two to 19 years, with the most evidence available for children under 12 years of age. Consistent with the original review, the most commonly studied psychological interventions for needle procedures were distraction, hypnosis, and cognitive behavioural therapy (CBT). The majority of included studies (19 of 39) examined distraction only. The additional studies from this review update continued to provide strong evidence for the efficacy of distraction and hypnosis. No evidence was available to support the efficacy of preparation and information, combined CBT (at least two or more cognitive or behavioural strategies combined), parent coaching plus distraction, suggestion, or virtual reality for reducing children's pain and distress. No conclusions could be drawn about interventions of memory alteration, parent positioning plus distraction, blowing out air, or distraction plus suggestion, as evidence was available from single studies only. In addition, the Risk of bias scores indicated several domains with high or unclear bias scores (for example, selection, detection, and performance bias) suggesting that the methodological rigour and reporting of RCTs of psychological interventions continue to have considerable room for improvement. Authors' conclusions Overall, there is strong evidence supporting the efficacy of distraction and hypnosis for needle-related pain and distress in children and adolescents, with no evidence currently available for preparation and information or both, combined CBT, parent coaching plus distraction, suggestion, or virtual reality. Additional research is needed to further assess interventions that have only been investigated in one RCT to date (that is, memory alteration, parent positioning plus distraction, blowing out air, and distraction plus suggestion). There are continuing issues with the quality of trials examining psychological interventions for needle-related pain and distress.