Janet Yamada

Systematic review of the psychometric properties, interpretability and feasibility of self-report pain intensity measures for use in clinical trials in children and adolescents

&NA; The aim of this study was to systematically review the psychometric properties, interpretability and feasibility of self‐report pain intensity measures for children and adolescents for use in clinical trials evaluating pain treatments. Databases were searched for self‐report measures of single‐item ratings of pain intensity for children aged 3–18 years. A total of 34 single‐item self‐report measures were found. The measures’ psychometric properties, interpretability and feasibility, were evaluated independently by two investigators according to a set of psychometric criteria. Six single‐item measures met the a priori criteria and were included in the final analysis. While these six scales were determined as psychometrically sound and show evidence of responsivity, they had varying degrees of interpretability and feasibility. No single scale was found to be optimal for use with all types of pain or across the developmental age span. Specific recommendations regarding the most psychometrically sound and feasible measures based on age/developmental level and type of pain are discussed. Future research is needed to strengthen the measurement of pain in clinical trials with children.

A Systematic Review of Internet-based Self-Management Interventions for Youth with Health Conditions

OBJECTIVE Critically appraise research evidence on effectiveness of internet self-management interventions on health outcomes in youth with health conditions. METHODS Published studies of internet interventions in youth with health conditions were evaluated. Electronic searches were conducted in EBM Reviews-Cochrane Central Register of Controlled Trials, Medline, EMBASE, CINAHL and PsychINFO. Two reviewers independently selected articles for review and assessed methodological quality. Of 29 published articles on internet interventions; only nine met the inclusion criteria and were included in analysis. RESULTS While outcomes varied greatly between studies, symptoms improved in internet interventions compared to control conditions in seven of nine studies. There was conflicting evidence regarding disease-specific knowledge and quality of life, and evidence was limited regarding decreases in health care utilization. CONCLUSIONS There are the beginnings of an evidence base that self-management interventions delivered via the internet improve selected outcomes in certain childhood illnesses.

Epidemiology and management of painful procedures in children in Canadian hospitals

Background Children being cared for in hospital undergo multiple painful procedures daily. However, little is known about the frequency of these procedures and associated interventions to manage the pain. We undertook this study to determine, for children in Canadian hospitals, the frequency of painful procedures, the types of pain management interventions associated with painful procedures and the influence of the type of hospital unit on procedural pain management. Methods We reviewed medical charts for infants and children up to 18 years of age who had been admitted to 32 inpatient units at eight Canadian pediatric hospitals between October 2007 and April 2008. We recorded all of the painful procedures performed and the pain management interventions that had been implemented in the 24-hour period preceding data collection. We performed descriptive and comparative (analysis of variance, χ2) analyses. Results Of the 3822 children included in the study, 2987 (78.2%) had undergone at least one painful procedure in the 24-hour period preceding data collection, for a total of 18 929 painful procedures (mean 6.3 per child who had any painful procedure). For 2334 (78.1%) of the 2987 children who had a painful procedure, a pain management intervention in the previous 24 hours was documented in the chart: 1980 (84.8%) had a pharmacologic intervention, 609 (26.1%) a physical intervention, 584 (25.0%) a psychologic intervention and 753 (32.3%) a combination of interventions. However, for only 844 (28.3%) of the 2987 children was one or more pain management interventions administered and documented specifically for a painful procedure. Pediatric intensive care units reported the highest proportion of painful procedures and analgesics administered. Interpretation For less than one-third of painful procedures was there documentation of one or more specific pain management interventions. Strategies for implementing changes in pain management must be tailored to the type of hospital unit.

Hair Cortisol as a Potential Biologic Marker of Chronic Stress in Hospitalized Neonates

Background: As preterm and term infants in the neonatal intensive care unit (NICU) undergo multiple stressful/painful procedures, research is required that addresses chronic stress. Objectives: To determine whether (a) hair cortisol levels differed between term and preterm infants exposed to stress in the NICU and (b) an association exists between hair cortisol levels and severity of illness or indicators of acute stress. Methods: Hair cortisol levels were determined using the ELISA method (solid-phase enzyme-linked immunoassay, Alpco Diagnostics, Windham, N.H., USA) in 60 infants >25 weeks gestational age at birth. Results: No significant differences were found between the hair cortisol levels of term infants compared to preterm infants in the NICU. When compared to a group of healthy term infants, hospitalized infants had significantly higher hair cortisol levels (t (76) = 2.755, p = 0.004). A subgroup analysis of the term NICU infants showed a statistically significant association between total number of ventilator days and hair cortisol levels. For every extra day on the ventilator, hair cortisol levels increased on average by 0.2 nmol/g (p = 0.03). 21% of the variance in hair cortisol levels was explained by the total number of days on the ventilator. Conclusions: Hair cortisol is influenced by days of ventilation in NICU term infants. This is a potentially valid outcome for chronic neonatal stress in these infants and warrants further investigation.

Procedural pain in newborns at risk for neurologic impairment

In the past decade, our knowledge of pain in newborn infants has advanced considerably. However, infants at significant risk for neurologic impairment (NI) have been systematically excluded from almost all research on pain in neonates. The objectives of this study were to compare: (a) the nature, frequency and prevalence of painful procedures, (b) analgesics and sedatives administered, and (c) the relationship between painful procedures and analgesia for neonates at risk for NI. One hundred and ninety‐four infants at high (cohort A, n=67), moderate (cohort B, n=59) and low (cohort C, n=68) risk for NI from two tertiary level Neonatal Intensive Care Units in Canada were included in a retrospective cohort study on the first 7 days of life. Data were collected from medical records and analyzed using chi‐square, ANOVA and regression approaches. All cohorts had a mean of >10 painful procedures per day during the first 2 days of life. There was an interaction effect between cohort group and day of life (F5,188=2.13, P<0.06) with cohort A having significantly more painful procedures on day 1 (F2,191=4.79, P<0.009). There was no statistical difference in the number of infants who received continuous infusion (F2,20=1.9, P=0.13) or bolus (F2,20=1.3, P=0.25) opioids or sedatives (F2,20=0.45, P=0.84) by cohort over the 7 day period. There was a statistical difference in bolus opioid administration for days 1 (P<0.05) and 2 (P<0.001) with less than 10% of infants in cohort A receiving bolus opioids compared with approximately 22–33% of infants in cohorts B and C. There was a statistically significant correlation between painful procedures and analgesic use (r=0.29, P<0.001), although significant associations existed for cohorts B and C only. The number of painful procedures and study site primarily accounted for the variance (61% in cohort B and 35% in cohort C) in analgesic use, while in cohort A, only study site contributed to the variance (16%). Neonates at the highest risk for NI had the greatest number of painful procedures and the least amount of opioids administered during the first day of life. There was no relationship between painful procedures and analgesic use in this group. As these infants are vulnerable to pain and its consequences, the rational underlying health professional strategies regarding painful procedures and analgesic use for procedural pain in this population urgently awaits exploration.

Consistent management of repeated procedural pain with sucrose in preterm neonates: Is it effective and safe for repeated use over time?

Objective:Preterm neonates undergo numerous painful procedures in the neonatal intensive care unit (NICU). Sucrose, with and without pacifiers, is effective and safe for relieving pain from single painful events. However, repeated use of sucrose for multiple painful procedures has not been adequately evaluated. The study objectives were to: 1) determine the efficacy and safety of consistent management of repeated procedural pain with sucrose; and 2) explore the impact of consistent pain management on clinical outcomes and neurobiological risk status. Methods:Sixty-six preterm infants were randomized to receive standard care (positioning and swaddling; n = 21), sterile water plus pacifier (n = 23), or 24% sucrose plus pacifier (n = 22) prior to all painful procedures in the NICU during the first 28 days of life. Also, at a routine heel lance at 7, 14, 21, and 28 days of life, data were collected to determine efficacy and immediate and long-term adverse events. Data on clinical outcomes and neurobiological risk status were collected at 28 days or NICU discharge. Results:There was no intervention by time interaction (P = 0.60). There was a significant main effect of intervention (P = 0.03) between the sucrose plus pacifier group, and the standard care group (P = 0.01), but there was no main effect of time (P = 0.72). No group differences existed for adverse events, clinical outcomes, or neurobiological risk status. Discussion:Consistent management of painful procedures with sucrose plus pacifier was effective and safe for preterm neonates during their stay in the NICU. Further exploration of consistent pain management with sucrose on clinical, developmental, and neurobiological outcomes is required.

Efficacy of sweet solutions for analgesia in infants between 1 and 12 months of age: a systematic review

Objective To compare the efficacy of oral sweet solutions to water or no treatment in infants aged 1–12 months during immunisation. Methods Randomised controlled trials (RCTs) were retrieved through internet searches or manual searches of reference lists. Search terms included newborn, infant, pain, sucrose and alternative names for sweet solutions. Summary estimates with 95% CIs were calculated and included relative risk (RR), risk difference (RD) and number needed to treat to benefit (NNTB) for dichotomous outcomes, and weighted mean differences (WMD) for continuous outcomes. Where pooling of results was not possible, a narrative summary of study results is presented. Results Of the 695 studies identified, 14 RCTs with 1674 injections met the inclusion criteria. Sucrose or glucose, compared to water or no treatment decreased crying during or following immunisation in 13 of the 14 studies. Infants receiving 30% glucose (three trials, 243 infants) had a decreased RR in crying incidence following immunisation (typical RR 0.80, 95% CI 0.69 to 0.93; RD −0.17, 95% CI −0.29 to −0.05; NNTB 6, 95% CI 3 to 20). With sucrose or glucose, there was a 10% WMD reduction in proportion of crying time (95% CI −18 to −2) and a 12 s reduction in crying duration (95% CI −23 to −0.7 s). An optimal dose of sucrose or glucose could not be ascertained due to the varied volumes and concentrations used. Conclusion Infants aged 1–12 months administered sucrose or glucose before immunisation had moderately reduced incidence and duration of crying. Healthcare professionals should consider using sucrose or glucose before and during immunisation.

The premature infant pain profile: evaluation 13 years after development.

ObjectiveTo review the (1) reliability, validation, feasibility, and clinical utility and (2) the use of the Premature Infant Pain Profile (PIPP) from 1996 to 2009 to determine the effectiveness of pain management strategies. MethodsData sources included MEDLINE, CINAHL, EMBASE, PsycINFO, and the Web of Science. Published studies evaluating the measurement properties of the PIPP and intervention studies using the PIPP as an outcome measure of acute pain were included. One reviewer screened studies for relevance and inclusion. Four reviewers rated intervention studies for methodological quality and extracted data for the evidence tables. ResultsOf the 62 studies included, 14 focused on the measurement properties of the PIPP. Reliability of the PIPP was supported in 5 studies and construct validation was supported in 13 studies. The feasibility of the PIPP was addressed in 4 studies, whereas clinical utility was discussed in 2 studies. Twenty-seven of the 48 studies that were considered to have high methodological quality used the PIPP as the major outcome to evaluate the effectiveness of pain management interventions in infants. DiscussionThe PIPP continues to be a reliable and valid measure of acute pain in infants with numerous positive validation studies. There is substantial support for the use of the PIPP as an effective outcome measure in pain intervention studies in infants. Further research with health professionals is required to better support the feasibility and clinical utility of this measure.

Comparison of Pain Responses in Infants of Different Gestational Ages

Background: There is a plethora of infant pain measures; however, none of them have been validated for extremely low for gestational age (ELGA) infants (<27 weeks’ gestation). To date, clinicians, researchers and parents use information gleaned from more mature infants to make inferences about pain in ELGA infants. Using physiological or behavioral pain indicators derived from more mature infants may lead to inaccurate assessments and management. Objectives: To compare physiological (heart rate, oxygen saturation) and behavioral (9 facial activities, cry) pain indicators of ELGA infants with infants of varying more mature gestational ages (GAs). Methods: The aim was to determine the effects of GA on pain response. GA was categorized into four mutually exclusive strata: <27 6/7 weeks, 28–31 6/7 weeks, 32–35 6/7 weeks and >36 weeks. Physiological data during four phases of a routine heel lance were collected by placing disposable ECG electrodes and pulse oximetry probes on the infant’s chest. Behavioral data were collected by videotaping facial activities, and cry data were collected by audio recording. Results: Four facial activities (brow bulge, eye squeeze, nasolabial furrow, vertical mouth stretch) in response to acute pain were present in ELGA infants. Facial activities increased following painful procedures and the magnitude of responses was proportional to GA with the youngest infants (<27 6/7 weeks GA) showing the least amount of change. Decreased oxygen saturation and increased heart rate were associated with the most invasive phase of the heel lance; however, the differences were neither clinically or statistically significant across age groups. Cry was not a sensitive pain indicator in ELGA infants, due to the presence of endotracheal tubes in this high-risk population. Discussion: ELGA infants have similar pain responses to older infants, but the responses are dampened. Other factors such as severity of illness, frequency of painful procedures or medication use should be examined, as they may influence the pain responses in ELGA infants.

A systematic review and meta-analyses of nonsucrose sweet solutions for pain relief in neonates.

BACKGROUND Sucrose has been demonstrated to provide analgesia for minor painful procedures in infants. However, results of trials investigating other sweet solutions for neonatal pain relief have not yet been synthesized. OBJECTIVE To establish the efficacy of nonsucrose sweet-tasting solutions for pain relief during painful procedures in neonates. METHOD The present article is a systematic review and meta-analyses of the literature. Standard methods of the Cochrane Neonatal Collaborative Review Group were used. Literature searches were reviewed for randomized controlled trials investigating the use of sweet solutions, except sucrose, for procedural pain management in neonates. Outcomes assessed included validated pain measures and behavioural and physiological indicators. RESULTS Thirty-eight studies (3785 neonates) were included, 35 of which investigated glucose. Heel lancing was performed in 21⁄38 studies and venipuncture in 11⁄38 studies. A 3.6-point reduction in Premature Infant Pain Profile scores during heel lances was observed in studies comparing 20% to 30% glucose with no intervention (two studies, 124 neonates; mean difference -3.6 [95% CI -4.6 to -2.6]; P<0.001; I2=54%). A significant reduction in the incidence of cry after venipuncture for infants receiving 25% to 30% glucose versus water or no intervention was observed (three studies, 130 infants; risk difference -0.18 [95% CI -0.31 to -0.05]; P=0.008, number needed to treat = 6 [95% CI 3 to 20]; I2=63%). CONCLUSIONS The present systematic review and meta-analyses demonstrate that glucose reduces pain scores and crying during single heel lances and venipunctures. Results indicate that 20% to 30% glucose solutions have analgesic effects and can be recommended as an alternative to sucrose for procedural pain reduction in healthy term and preterm neonates.