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PEDIATRICS
  • Achievement of Targeted Saturation Values in Extremely Low Gestational Age Neonates Resuscitated With Low or High Oxygen Concentrations: A Prospective, Randomized Trial

    OBJECTIVE. Extremely low gestational age neonates have very low oxygen saturation in utero and an immature antioxidant defense system. Abrupt increases in oxygen saturation after birth may cause oxidative stress. We compared achievement of a targeted oxygen saturation of 85% at 10 minutes of life when resuscitation was initiated with low or high fractions of inspired oxygen and levels were adjusted according to preductal pulse oxygen saturation values.

    METHODS. A prospective, randomized, clinical trial was performed in 2 level III neonatal referral units. Patients of ≤28 weeks of gestation who required active resuscitation were randomly assigned to the low-oxygen group (fraction of inspired oxygen: 30%) or the high-oxygen group (fraction of inspired oxygen: 90%). Every 60 to 90 seconds, the fraction of inspired oxygen was increased in 10% steps if bradycardia occurred (<100 beats per minute) or was decreased in similar steps if pulse oxygen saturation reached values of >85%. Preductal pulse oxygen saturation was continuously monitored.

    RESULTS. The fraction of inspired oxygen in the low-oxygen group was increased stepwise to 45% and that in the high-oxygen group was reduced to 45% to reach a stable pulse oxygen saturation of ~85% at 5 to 7 minutes in both groups. No differences in oxygen saturation in minute-to-minute registers were found independent of the initial fraction of inspired oxygen used 4 minutes after cord clamping. No differences in mortality rates in the early neonatal period were detected.

    CONCLUSIONS. Resuscitation can be safely initiated for extremely low gestational age neonates with a low fraction of inspired oxygen (~30%), which then should be adjusted to the infant's needs, reducing the oxygen load to the neonate.



  • Pulse Oxygen Saturation Levels and Arterial Oxygen Tension Values in Newborns Receiving Oxygen Therapy in the Neonatal Intensive Care Unit: Is 85% to 93% an Acceptable Range?

    OBJECTIVE. Our aim was to define the relationship of Pao2 and pulse oxygen saturation values during routine clinical practice and to evaluate whether pulse oxygen saturation values between 85% and 93% were associated with Pao2 levels of <40 mmHg.

    METHODS. Prospective comparison of Pao2 and pulse oxygen saturation values in 7 NICUs at sea level in 2 countries was performed. The Pao2 measurements were obtained from indwelling arterial catheters; simultaneous pulse oxygen saturation values were recorded if the pulse oxygen saturation values changed <1% before, during, and after the arterial gas sample was obtained.

    RESULTS. We evaluated 976 paired Pao2/pulse oxygen saturation values in 122 neonates. Of the 976 samples, 176 (18%) from infants breathing room air had a mean pulse oxygen saturation of 93.9 ± 4.3% and a median of 95.5%. The analysis of 800 samples from infants breathing supplemental oxygen revealed that, when pulse oxygen saturation values were 85% to 93%, the mean Pao2 was 56 ± 14.7 mmHg and the median 54 mmHg. At this pulse oxygen saturation level, 86.8% of the samples had Pao2 values of 40 to 80 mmHg, 8.6% had values of <40 mmHg, and 4.6% had values of >80 mmHg. When the pulse oxygen saturation values were >93%, the mean Pao2 was 107.3 ± 59.3 mmHg and the median 91 mmHg. At this pulse oxygen saturation level, 39.5% of the samples had Pao2 values of 40 to 80 mmHg and 59.5% had values of >80 mmHg.

    CONCLUSIONS. High Pao2 occurs very rarely in neonates breathing supplemental oxygen when their pulse oxygen saturation values are 85% to 93%. This pulse oxygen saturation range also is infrequently associated with low Pao2 values. Pulse oxygen saturation values of >93% are frequently associated with Pao2 values of >80 mmHg, which may be of risk for some newborns receiving supplemental oxygen.



  • Healthy Children With Frequent Fractures: How Much Evaluation Is Needed?

    OBJECTIVE. We performed a case-control study to determine whether occult bone disease is associated with a history of frequent fractures in children.

    METHODS. Healthy children with ≥2 incidences of low-energy fractures were recruited (n = 68). Children with no history of fractures served as control subjects (n = 57). Food logs, activity surveys, physical examinations, laboratory tests, and dual-energy radiographic absorptiometry were used.

    RESULTS. Bone mineral density z scores were significantly reduced in case subjects, compared with control subjects. Three case subjects (4.3%) and 1 control subject (1.8%) had bone mineral density z scores below the expected range. Of those 4 subjects, 2 had dairy avoidance and 2 had delayed puberty. An additional case subject had evidence of vitamin D deficiency. A significant number of subjects (20% of case subjects and 23% of control subjects) had idiopathic hypercalcuria, based on 24-hour urine collections. Among the case subjects, bone mineral density z scores were significantly lower for those with idiopathic hypercalcuria. Among the control subjects, the presence of idiopathic hypercalcuria did not affect bone mineral density. The case subjects with idiopathic hypercalcuria accounted for virtually all of the differences in bone mineral density between the case and control groups. Analysis of parathyroid hormone and 1,25-dihydroxy-vitamin D levels showed that children with frequent fractures and hypercalcuria had renal hypercalcuria, whereas children with no fractures and hypercalcuria had absorptive hypercalcuria.

    CONCLUSIONS. We identified a significant association between a history of frequent fractures and hypercalcuria in children. We propose that the appropriate screening evaluation for children who present with a history of frequent fractures consists of a dietary history targeted at calcium and vitamin D intakes, a physical examination to assess for pubertal delay, and urinary calcium concentration/creatinine ratio determination to assess for hypercalcuria. Children with abnormalities in this screening should undergo dual-energy radiographic absorptiometry and appropriate evaluation.



  • Impact of Immunization at Sick Visits on Well-Child Care

    OBJECTIVE. We assessed the impact of immunization at sick visits on subsequent and overall well-child care.

    METHODS. We performed a retrospective cohort study using electronic health record data from 4 urban practices affiliated with an academic medical center. Participants included all children born between September 1, 2003, and July 31, 2004, with a visit at a study practice before 6 weeks of age and ≥1 sick visit (n = 1675). The main outcome measures were (1) attendance at a well-child visit within 60 days after an index sick visit by children due for vaccines and preventive care and (2) the overall number of well-child visits kept by children between 6 weeks and 13 months of age.

    RESULTS. Among all demographic and health-related factors considered, immunization receipt at a sick visit was associated most strongly with decreased subsequent well-child care. Among children already delayed (late) for vaccines, 31% returned for well-child care if immunizations were given at eligible sick visits, compared with 47% of those who received no vaccines (risk difference, with adjustment for covariates: –16%). Among those without immunization delay, 42% of children who received vaccines returned for well-child care, compared with 73% of those who received no vaccines (risk difference: –31%). Although 5 well-child visits are recommended, children with no immunizations at sick visits had an adjusted predicted number of 3.8 well-child visits, those with 1 sick visit with immunizations had 3.3 visits, and those with ≥2 sick visits with immunizations had 2.8 visits between 6 weeks and 13 months of age.

    CONCLUSIONS. Immunization at sick visits was associated with decreased rates of well-child care, especially among those without previous vaccine delay. This strong association between immunization at sick visits and well-child care should be considered in any plan to restructure pediatric preventive care.



  • Patterns of Brain Injury in Neonates Exposed to Perinatal Sentinel Events

    OBJECTIVES. We studied (1) the pattern of brain injury in term neonates with encephalopathy with evidence of a preceding hypoxic sentinel event, (2) prenatal and perinatal risk factors, and (3) the correlation between neuroimaging findings and developmental outcomes.

    METHODS. We identified, among 500 term neonates with encephalopathy who were studied with MRI between 1992 and 2005, 48 infants with evidence of a preceding acute hypoxic event, and we reviewed their MRI scans retrospectively. Prenatal and perinatal data were compared with those for term normal low-risk infants. Neurodevelopmental outcomes were assessed at a minimum of 12 months.

    RESULTS. Five patterns of brain injury were identified, as follows: pattern I, basal ganglia and thalami lesions associated with severe white matter damage (n = 6; 14%); pattern II, basal ganglia and thalami lesions with mild or moderate white matter changes (n = 24; 56%); pattern III, isolated thalamic injury (n = 2; 5%); pattern IV, moderate white matter damage only (n = 1; 2%); pattern V, mild white matter changes or normal findings (n = 10; 23%). No scan showed evidence of long-standing injury. The internal capsule was abnormal in 93% of infants with patterns I and II, and 86% of those infants died or developed cerebral palsy. Infants with patterns III and IV had developmental delay and diplegic cerebral palsy, respectively. Pattern V was associated with normal outcomes. Case infants were significantly more often of African descent, born to pluriparous or hypertensive mothers. Uterine rupture followed previous cesarean section in 8 of 11 cases. Cord prolapse accompanied undiagnosed breech presentation in 4 of 9 cases.

    CONCLUSIONS. Basal ganglia and thalami lesions are the imaging signature in term neonates exposed to hypoxic-ischemic sentinel events. Patterns of central gray matter and secondary white matter injury were associated with higher risks of severe morbidity and death. Affected infants did not seem intrinsically different from our low-risk population. These data support the need for anticipating sentinel events and expediting delivery.



  • Systematic Intervention to Reduce Central Line-Associated Bloodstream Infection Rates in a Pediatric Cardiac Intensive Care Unit

    OBJECTIVE. Our goal was to determine whether an intervention involving staff education, increased awareness, and practice changes would decrease central line–associated bloodstream infection rates in a pediatric cardiac ICU.

    METHODS. A retrospective, interventional study using an interrupted time-series design was conducted to compare central line–associated bloodstream infection rates during 3 time periods for all patients admitted to our pediatric cardiac ICU between April 1, 2004, and December 31, 2006. During the preintervention period (April 2004 to December 2004), a committee was convened to track and prevent nosocomial infections. Pretesting demonstrated knowledge deficits regarding nosocomial infection prevention, and educational tools were developed. During the partial intervention period (January 2005 to March 2006), a comprehensive central line–associated bloodstream infection prevention initiative was implemented, including establishment of a unit-based infection control nurse position, education for physicians and nurses, real-time feedback on central line–associated bloodstream infection data, implementation of central venous line insertion, access, and maintenance bundles, and introduction of daily goal sheets on rounds that emphasized timely central venous line removal. Central line–associated bloodstream infection rates in the preintervention, partial intervention, and full intervention (April 2006 to December 2006) periods were compared.

    RESULTS. The estimated mean preintervention central line–associated bloodstream infection rate was 7.8 infections per 1000 catheter-days, which decreased to 4.7 infections per 1000 catheter-days in the partial intervention period and 2.3 infections per 1000 catheter-days in the full intervention period. The preintervention central line–associated bloodstream infection rate was significantly higher than the median rate of 3.5 infections per 1000 catheter-days for multidisciplinary PICUs reporting to the National Healthcare Safety Network. During the full intervention period, our central line–associated bloodstream infection rate was lower than this pediatric benchmark, although statistical significance was not achieved.

    CONCLUSIONS. A multidisciplinary, evidence-based initiative resulted in a significant reduction in central line–associated bloodstream infections in our pediatric cardiac ICU.



  • Usefulness of Childhood Non-High Density Lipoprotein Cholesterol Levels Versus Other Lipoprotein Measures in Predicting Adult Subclinical Atherosclerosis: The Bogalusa Heart Study

    OBJECTIVE. This study sought to examine the usefulness of childhood non–high-density lipoprotein cholesterol level versus low-density lipoprotein cholesterol level, high-density lipoprotein cholesterol level, triglyceride level, apolipoprotein B level, apolipoprotein A-I level, total cholesterol/high-density lipoprotein cholesterol ratio, and apolipoprotein B/apolipoprotein A-I ratio in predicting adult excess carotid intima-media thickness, an indicator of subclinical atherosclerosis.

    METHODS. This retrospective cohort study included 437 black and white subjects (70% white and 40% male) who participated in the Bogalusa Heart Study as children 5 to 17 years of age and as adults 16 to 19 years later.

    RESULTS. In analyses of each lipoprotein measure as a risk factor for predicting excess carotid intima-media thickness in adulthood, non–high-density lipoprotein cholesterol level, low-density lipoprotein cholesterol level, total cholesterol/high-density lipoprotein cholesterol ratio, apolipoprotein B level, and apolipoprotein B/apolipoprotein A-I ratio emerged as significant predictors, with respective odds ratios of 2.60, 2.95, 1.78, 1.44, and 1.69, after adjustment for childhood BMI, systolic blood pressure, other lipoprotein measures, and follow-up years; the odds ratios for high-density lipoprotein cholesterol, triglyceride, and apolipoprotein A-I levels were not significant. Regarding the discriminating value of different childhood lipoprotein measures in predicting excess carotid intima-media thickness in adulthood, analyses of the area under the receiver operating characteristic curve for each lipoprotein measure, adjusted for the aforementioned nonlipoprotein covariates, indicated that the value of 0.65 for the non–high-density lipoprotein cholesterol level was similar in magnitude to those for other lipoprotein measures, with values ranging from 0.62 to 0.66.

    CONCLUSIONS. Childhood non–high-density lipoprotein cholesterol levels are as good as other lipoprotein measures in predicting subclinical atherosclerosis in adulthood, which has practical implications for coronary artery disease risk assessment and intervention in pediatric populations.



  • Injuries Among Infants Treated in Emergency Departments in the United States, 2001-2004

    OBJECTIVE. The objective of this study was to present a detailed examination of unintentional injuries in infants ≤12 months of age treated in emergency departments.

    METHODS. We conducted a retrospective analysis of data for infants ≤12 months of age from the National Electronic Surveillance System-All Injury Program for 2001–2004. Sample weights provided by the National Electronic Surveillance System-All Injury Program were used to make national estimates.

    RESULTS. An estimated 1314000 injured infants were treated in US emergency departments for nonfatal unintentional injuries during the 4-year period of 2001–2004, ~1 infant every 1.5 minutes. Falls were the leading cause of nonfatal unintentional injuries for infants. Overall, the patients were more likely to be male (55.2%) than female (44.8%). Contusions/abrasions were the leading diagnosis overall (26.7%). Contusion/abrasion, laceration, hematoma, foreign-body, and puncture injuries occurred most frequently to the head or neck region. More than one third of fractures (37.2%) were to the arm or hand. Bed was the product most frequently noted as being involved in the injury event for every age except 2 and 12 months (car seat was the most frequently noted product at 2 months of age, and stairs were top ranked at 12 months). Product rank changed markedly as age increased.

    CONCLUSIONS. The influences of the social environment, the physical environment, and products change as infants mature in the first year of life; this was substantiated in our study by the shift in the relative importance of products involved in injuries according to month of age. The concept that aspects of safety must adapt in anticipation of developmental stage is critical.



  • Underimmunization of American Indian and Alaska Native Children

    OBJECTIVE. The goal was to determine whether disparities in childhood immunization coverage exist between American Indian/Alaska Native children and non-Hispanic white children.

    METHODS. We compared immunization coverage with the 4 diphtheria-tetanus-pertussis, 3 poliovirus, 1 measles-mumps-rubella, 3 Haemophilus influenza type b, and 3 hepatitis B(4:3:1:3:3) series and its individual vaccine components (≥4 doses of diphtheria, tetanus, and pertussis vaccine; ≥3 doses of oral or inactivated polio vaccine; ≥1 dose of measles, mumps, and rubella vaccine; ≥3 doses of Haemophilus influenzae type b vaccine; and ≥3 doses of hepatitis B vaccine) between American Indian/Alaska Native children and non-Hispanic white children from 2000 to 2005, using data from the National Immunization Survey.

    RESULTS. Although immunization coverage increased for both populations from 2001 to 2004, American Indian/Alaska Native children had significantly lower immunization coverage, compared with non-Hispanic white children, over that time period. In 2005, coverage continued to increase for American Indian/Alaska Native children but decreased for non-Hispanic white children, and no statistically significant disparity in 4:3:1:3:3 coverage was evident in that year.

    CONCLUSIONS. Disparities in immunization coverage for American Indian/Alaska Native children have been present, but unrecognized, since 2001. The absence of a disparity in coverage in 2005 is encouraging but is tempered by the fact that coverage for non-Hispanic white children decreased in that year.



  • Ibuprofen-Induced Patent Ductus Arteriosus Closure: Physiologic, Histologic, and Biochemical Effects on the Premature Lung

    OBJECTIVE. The goal was to study the pulmonary, biochemical, and morphologic effects of a persistent patent ductus arteriosus in a preterm baboon model of bronchopulmonary dysplasia.

    METHODS. Preterm baboons (treated prenatally with glucocorticoids) were delivered at 125 days of gestation (term: 185 days), given surfactant, and ventilated for 14 days. Twenty-four hours after birth, newborns were randomly assigned to receive either ibuprofen (to close the patent ductus arteriosus; n = 8) or no drug (control; n = 13).

    RESULTS. After treatment was started, the ibuprofen group had significantly lower pulmonary/systemic flow ratio, higher systemic blood pressure, and lower left ventricular end diastolic diameter, compared with the control group. There were no differences in cardiac performance indices between the groups. Ventilation index and dynamic compliance were significantly improved with ibuprofen. The improved pulmonary mechanics in ibuprofen-treated newborns were not attributable to changes in levels of surfactant protein B, C, or D, saturated phoshatidylcholine, or surfactant inhibitory proteins. There were no differences in tracheal concentrations of cytokines commonly associated with the development of bronchopulmonary dysplasia. The groups had similar messenger RNA expression of genes that regulate inflammation and remodeling in the lung. Lungs from ibuprofen-treated newborns were significantly drier (lower wet/dry ratio) and expressed 2.5 times more epithelial sodium channel protein than did control lungs. By 14 days after delivery, control newborns had morphologic features of arrested alveolar development (decreased alveolar surface area and complexity), compared with age-matched fetuses. In contrast, there was no evidence of alveolar arrest in the ibuprofen-treated newborns.

    CONCLUSIONS. Ibuprofen-induced patent ductus arteriosus closure improved pulmonary mechanics, decreased total lung water, increased epithelial sodium channel expression, and decreased the detrimental effects of preterm birth on alveolarization.



  • Social-Emotional Screening Status in Early Childhood Predicts Elementary School Outcomes

    OBJECTIVE. The goal was to examine whether children who screen positive for social-emotional/behavioral problems at 12 to 36 months of age are at elevated risk for social-emotional/behavioral problems in early elementary school.

    METHODS. The sample studied (N = 1004) comprised an ethnically (33.3% minority) and socioeconomically (17.8% living in poverty and 11.3% living in borderline poverty) diverse, healthy, birth cohort from a metropolitan region of the northeastern United States. When children were 12 to 36 months of age (mean age: 23.8 months; SD: 7.1 months), parents completed the Brief Infant-Toddler Social and Emotional Assessment and questions concerning their level of worry about their child's behavior, emotions, and social development. When children were in early elementary school (mean age: 6.0 years; SD: 0.4 years), parents completed the Child Behavior Checklist and teachers completed the Teacher Report Form regarding behavioral problems. In a subsample (n = 389), parents reported child psychiatric status.

    RESULTS. Brief Infant-Toddler Social and Emotional Assessment screen status and parental worry were associated significantly with school-age symptoms and psychiatric disorders. In multivariate analyses that included Brief Infant-Toddler Social and Emotional Assessment status and parental worry, Brief Infant-Toddler Social and Emotional Assessment scores significantly predicted all school-age problems, whereas worry predicted only parent reports with the Child Behavior Checklist. Children with of-concern scores on the problem scale of the Brief Infant-Toddler Social and Emotional Assessment were at increased risk for parent-reported subclinical/clinical levels of problems and for psychiatric disorders. Low competence scores predicted later teacher-reported subclinical/clinical problems and parent-reported disorders. Worry predicted parent-reported subclinical/clinical problems. Moreover, the Brief Infant-Toddler Social and Emotional Assessment identified 49.0% of children who exhibited subclinical/clinical symptoms according to teachers and 67.9% of children who later met the criteria for a psychiatric disorder.

    CONCLUSIONS. Screening with a standardized tool in early childhood has the potential to identify the majority of children who exhibit significant emotional/behavioral problems in early elementary school.



  • The Best-Interest Standard Is Not Applied for Neonatal Resuscitation Decisions

    OBJECTIVE. Legal and ethical standards require resuscitation when it is considered to be in the patient's best interest. We hypothesized that newborn infants might be dealt with according to different standards, compared with older patients.

    METHODS. An anonymous questionnaire describing 8 currently incompetent patients with potential neurologic sequelae who required resuscitation was administered to groups of physicians and students. Survival and morbidity rates were explicitly described; a very preterm infant, a full term infant and a 2-month-old infant had identical outcomes. Two patients, a 7-month-old infant and an 80-year-old patient, were previously significantly impaired. Respondents were asked whether resuscitation was in the patient's best interest and whether they would comply with the families' wishes if resuscitation was refused.

    RESULTS. There was an 85% response rate (n = 524). The largest proportions of respondents stated that it was in the best interests of the 2-month-old infant and the 7-year-old child to be resuscitated (97% and 94%, respectively), followed by the 50-year-old patient and the term infant (87%), the 2 patients with 5% chance of survival (76% and 80%), the premature infant (69%), and finally the 80-year-old patient (32%). Approximately one fifth of the respondents who thought that it was in a patient's best interests to be resuscitated would nevertheless accept the family's refusal of resuscitation for all scenarios except the 80-year-old patient (72% acceptance) and the preterm infant (54% acceptance).

    CONCLUSIONS. Whether resuscitation is considered in a patient's best interests is not closely related to survival rates or disability. Newborn infants and particularly preterm infants are systematically devalued, in comparison with older patients whose outcomes are the same or worse. Accepting a family's refusal of resuscitation, even among respondents who thought that resuscitation was in the patient's best interest, was much more common for the newborns.



  • Newborn Hearing Screening and Detection of Congenital Cytomegalovirus Infection

    OBJECTIVES. The objectives were to determine the frequency of congenital cytomegalovirus infection among newborns who did not pass hearing screening tests or had confirmed hearing loss and to determine how often abnormal hearing screening results were the only manifestation of congenital cytomegalovirus infection.

    METHODS. Retrospective chart review was performed for newborns who had abnormal hearing screening results and positive urine cytomegalovirus culture results at Parkland Memorial Hospital between September 1, 1999, and August 31, 2004.

    RESULTS. During the 5-year study period, 572 of 79047 newborns (7 of 1000 live births) did not pass hearing screening tests. Cytomegalovirus infection was identified in 24 (5%) of 483 tested infants and 16 (6%) of the 256 infants with subsequently confirmed hearing impairment. Of those 16 infants, 12 (75%) were identified as having congenital cytomegalovirus infection only because of failure to pass newborn hearing screening tests.

    CONCLUSIONS. Congenital cytomegalovirus infection was present for 6% of newborns with confirmed hearing impairment, and the majority of those infants were identified on the basis of abnormal newborn hearing screening results.



  • Unbound Bilirubin Concentration is Associated With Abnormal Automated Auditory Brainstem Response for Jaundiced Newborns

    OBJECTIVE. This study was conducted to determine whether incidental jaundice affects automated auditory brainstem response results.

    METHODS. We reviewed the medical charts of jaundiced newborns of ≥34 weeks of gestation who underwent automated auditory brainstem response testing within 4 hours of plasma total bilirubin concentration and unbound bilirubin concentration measurements. We tested the hypothesis that the likelihood of abnormal automated auditory brainstem response results would increase as total bilirubin and unbound bilirubin concentrations increased.

    RESULTS. Forty-four infants with proximate total bilirubin concentration, unbound bilirubin concentration, and automated auditory brainstem response measurements were identified, and 4 (9%) had bilateral refer automated auditory brainstem response results. The mean total bilirubin concentration of 21.4 mg/dL (SD: 4.0 mg/dL; range: 14.4–29.5 mg/dL) for the 40 infants with bilateral pass automated auditory brainstem response results was not significantly different from that of 23.0 mg/dL (range: 14.9–33.1 mg/dL) for the 4 infants with bilateral refer automated auditory brainstem response results. However, the mean unbound bilirubin concentration of 1.32 µg/dL (range: 0.22–2.99 µg/dL) for the 40 infants with bilateral pass results was significantly lower than the mean of 2.62 µg/dL (range: 0.88–4.41 µg/dL) for the 4 infants with bilateral refer results. Logistic regression showed that increasing unbound bilirubin concentrations but not increasing total bilirubin concentrations were associated with of bilateral refer automated auditory brainstem response results.

    CONCLUSIONS. The probability of bilateral refer automated auditory brainstem response results increases significantly with increasing unbound bilirubin concentrations but not with increasing total bilirubin concentrations. Because unbound bilirubin concentrations are also more closely correlated with bilirubin neurotoxicity than are total bilirubin concentrations, bilateral refer automated auditory brainstem response results for jaundiced newborns may indicate increased risk of bilirubin neurotoxicity, in addition to the possibility of congenital deafness.



  • Needle-Free Powder Lidocaine Delivery System Provides Rapid Effective Analgesia for Venipuncture or Cannulation Pain in Children: Randomized, Double-Blind Comparison of Venipuncture and Venous Cannulation Pain After Fast-Onset Needle-Free Powder Lidocaine or Placebo Treatment Trial

    OBJECTIVE. The Comparison of Venipuncture and Venous Cannulation Pain After Fast-Onset Needle-Free Powder Lidocaine or Placebo Treatment trial was a randomized, single-dose, double-blind, phase 3 study investigating whether a needle-free powder lidocaine delivery system (a sterile, prefilled, disposable system that delivers lidocaine powder into the epidermis) produces effective local analgesia within 1 to 3 minutes for venipuncture and peripheral venous cannulation procedures in children.

    METHODS. Pediatric patients (3–18 years of age) were randomly assigned to treatment with the needle-free powder lidocaine delivery system (0.5 mg of lidocaine and 21 ± 1 bar of pressure; n = 292) or a sham placebo system (n = 287) at the antecubital fossa or the back of the hand 1 to 3 minutes before venipuncture or cannulation. All patients rated the administration comfort of the needle-free systems and the pain of the subsequent venous access procedures with the Wong-Baker Faces Pain Rating Scale (from 0 to 5). Patients 8 to 18 years of age also provided self-reports with a visual analog scale, and parents provided observational visual analog scale scores for their child's venous access pain. Safety also was assessed.

    RESULTS. Immediately after administration, mean Wong-Baker Faces scale scores were 0.54 and 0.24 in the active system and sham placebo system groups, respectively. After venipuncture or cannulation, mean Wong-Baker Faces scale scores were 1.77 ± 0.09 and 2.10 ± 0.09 and mean visual analog scale scores were 22.62 ± 1.80 mm and 31.97 ± 1.82 mm in the active system and sham placebo system groups, respectively. Parents' assessments of their child's procedural pain were also lower in the active system group (21.35 ± 1.43 vs 28.67 ± 1.66). Treatment-related adverse events were generally mild and resolved without sequelae. Erythema and petechiae were more frequent in the active system group.

    CONCLUSIONS. The needle-free powder lidocaine delivery system was well tolerated and produced significant analgesia within 1 to 3 minutes.




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