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Relative effectiveness of additive pain interventions during vaccination in infants.

ABSTRACT: Vaccine injections can cause acute pain and distress in infants, which can contribute to dissatisfaction with the vaccination experience and vaccine hesitancy. We sought to compare the effectiveness of additive pain interventions administered consistently during vaccine injections in the first year of life.We conducted a multicentre, longitudinal, double-blind, add-on, randomized controlled trial. Healthy infants were randomly assigned to 1 of 4 levels of pain management for all vaccine injections at 2, 4, 6 and 12 months: (i) placebo control; (ii) parent-directed video education about infant soothing; (iii) the video plus sucrose administered orally or (iv) the video plus sucrose plus liposomal lidocaine applied topically. All infants benefit from injection techniques that minimize pain. We used a double-dummy design; hence all parents watched a video (active psychological intervention or placebo) and all infants received oral solution (sucrose or placebo) and topical cream (lidocaine or placebo). We assessed infant distress during 3 phases - preinjection (baseline), vaccine injection (needle), and 1 minute postinjection (recovery) - using the Modified Behavioural Pain Scale (range 0-10). We compared scores between groups and across infant ages using a mixed-model repeated-measures analysis.A total of 352 infants participated in the study, from Jan. 17, 2012, to Feb. 2, 2016. Demographics did not differ among intervention groups (p > 0.05). Baseline pain scores did not differ among intervention groups (p = 0.4), but did differ across ages (p < 0.001). Needle pain scores differed among groups (p = 0.003) and across ages (p < 0.001). The mean (± standard deviation) needle score was 6.3 (± 0.8) in the video-sucrose-lidocaine group compared with 6.7 (± 0.8) in each of the other groups. There were no other between-group differences. Recovery scores did not differ among groups (p = 0.98), but did differ across ages (p < 0.001).Only liposomal lidocaine provided consistent analgesia within an additive pain intervention regimen during vaccinations in infants. Trial registration: ClinicalTrials.gov, no. NCT01503060.

SUBMITTER: Taddio A

PROVIDER: S-EPMC5305402 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature

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Relative effectiveness of additive pain interventions during vaccination in infants.

Taddio Anna A Riddell Rebecca Pillai RP Ipp Moshe M Moss Steven S Baker Stephen S Tolkin Jonathan J Malini Dave D Feerasta Sharmeen S Govan Preeya P Fletcher Emma E Wong Horace H McNair Caitlin C Mithal Priyanjali P Stephens Derek D

CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne 20161212 6

<h4>Background</h4>Vaccine injections can cause acute pain and distress in infants, which can contribute to dissatisfaction with the vaccination experience and vaccine hesitancy. We sought to compare the effectiveness of additive pain interventions administered consistently during vaccine injections in the first year of life.<h4>Methods</h4>We conducted a multicentre, longitudinal, double-blind, add-on, randomized controlled trial. Healthy infants were randomly assigned to 1 of 4 levels of pain ...[more]

PMID: 27956393

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Project description:BACKGROUND:Previous systematic reviews have examined preterm infants' long-term neurodevelopment after neonatal intensive care unit (NICU) discharge, although none have explored the effectiveness of interventions on preterm infants' neurodevelopment during NICU hospitalization. The aim of this review is to evaluate whether interventions, i.e., sensory stimulation, parental involvement, and control of environment, improve preterm infants' neurodevelopment during their NICU hospitalization. METHODS:Experimental studies such as randomized controlled/clinical trials (RCTs) and cluster RCT will be included in this systematic review. Selected studies will be published in English or in French, in the past 15 years from 2002 to 2017. The following electronic databases will be searched to locate relevant studies: CINAHL, MEDLINE, PubMed, EMBASE (OVID), Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science. For all steps in selecting studies, agreement will be reached between two experts in neonatology. Data extraction will be performed independently by the two same experts and will then be compared. The Cochrane assessment tool will be used to screen the studies for risk of bias. A meta-analysis will be performed if the included studies are sufficiently homogeneous. Results will be analyzed using a standardized mean difference (with a 95% confidence interval). Statistical heterogeneity will be evaluated using the ? 2 test at the significance level of 0.1 and the I 2 with the classification suggested by PRISMA-P. If possible, subgroup analyses will be carried out considering preterm infants' gestational age, length of NICU hospitalization, and the characteristics of the intervention such as who delivered it, the type, the dose, the frequency, and the duration. Data synthesis will be performed using the RevMan 5.1 software. Publication bias and selection of variables in publication will be examined using the graphical method of funnel plot and with the statistical test of Egger. Quality of the evidence of all outcomes will be assessed using the Grades of Recommendations Assessment, Development and Evaluation (GRADE) Working Group. DISCUSSION:The results of this systematic review will highlight which interventions are effective for promoting preterm infants' neurodevelopment during NICU hospitalization and will contribute to the body of knowledge in neonatal care by providing guidance for NICU clinical practice and research. SYSTEMATIC REVIEW REGISTRATION:PROSPERO CRD42017047072.

Project description:BackgroundAlthough global progress in measles control has been realized, achieving elimination has proven difficult in many regions of the world. China has adopted a goal of measles elimination but recent outbreaks predominantly affecting children <8 months who are ineligible for vaccination and incompletely protected by maternal antibodies has impeded progress. We assess the cost-effectiveness of adding an initial measles vaccine dose in China to earlier than the currently recommended 8 months of age.MethodsWe conducted a cost-utility analysis comparing the costs and health benefits associated with adding a measles vaccine dose to the routine schedule at 4, 5, 6 or 7 months compared to the current recommendation for the first dose at age 8 months. A decision analytic model was developed in Microsoft Excel, including five non-severe and two fatal health outcomes associated with measles infection. Model parameters were informed by the literature and surveillance data. Future costs and health benefits were discounted at 3%. Primary outcomes included costs, Quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER) over a lifetime time horizon.ResultsLowering the recommended age for initiating the measles vaccination series to address susceptibility in children <8 months provided incremental health gains compared to minimal costs at the individual-level. The ICER was most favorable ($232.70 per QALY gain) for administering an initial dose at 4 months of age due to fewer incremental program costs when shifting measles administration to an immunization visit already established under the Chinese vaccination program.ConclusionWe found potential beneficial health gains at a minimum cost associated with adding an earlier measles dose <8 months of age in China. Further investigation about disease transmission dynamics is required to more fully assess the tradeoffs of administering measles at a younger age to infants in China.

Project description:BackgroundNewborn infants affected by hypoxic-ischemic encephalopathy (HIE) undergo therapeutic hypothermia. As this treatment seems to be associated with pain, and intensive and invasive care is needed, pharmacological interventions are often used. Moreover, painful procedures in the newborn period can affect pain responses later in life, impair brain development, and possibly have a long-term negative impact on neurodevelopment and quality of life.ObjectivesTo determine the effects of pharmacological interventions for pain and sedation management in newborn infants undergoing therapeutic hypothermia. Primary outcomes were analgesia and sedation, and all-cause mortality to discharge.Search methodsWe searched CENTRAL, PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and the trial register ISRCTN in August 2021. We also checked the reference lists of relevant articles to identify additional studies.Selection criteriaWe included randomized controlled trials (RCT), quasi-RCTs and cluster-randomized trials comparing drugs used for the management of pain or sedation, or both, during therapeutic hypothermia: any opioids (e.g. morphine, fentanyl), alpha-2 agonists (e.g. clonidine, dexmedetomidine), N-Methyl-D-aspartate (NMDA) receptor antagonist (e.g. ketamine), other analgesics (e.g. paracetamol), and sedatives (e.g. benzodiazepines such as midazolam) versus another drug, placebo, no intervention, or non-pharmacological interventions. Primary outcomes were analgesia and sedation, and all-cause mortality to discharge.Data collection and analysisTwo review authors independently assessed studies identified by the search strategy for inclusion. We planned to use the GRADE approach to assess the certainty of evidence. We planned to assess the methodological quality of included trials using Cochrane Effective Practice and Organisation of Care Group (EPOC) criteria (assessing randomization, blinding, loss to follow-up, and handling of outcome data). We planned to evaluate treatment effects using a fixed-effect model with risk ratio (RR) for categorical data and mean, standard deviation (SD), and mean difference (MD) for continuous data. MAIN RESULTS: We did not find any completed studies for inclusion. Amongst the four excluded studies, topiramate and atropine were used in two and one trial, respectively; one study used dexmedetomidine and was initially reported in 2019 to be a randomized trial. However, it was an observational study (correction in 2021). We identified one ongoing study comparing dexmedetomidine to morphine.Authors' conclusionsWe found no studies that met our inclusion criteria and hence there is no evidence to recommend or refute the use of pharmacological interventions for pain and sedation management in newborn infants undergoing therapeutic hypothermia.

Project description:BackgroundRespiratory syncytial virus (RSV) is the dominant cause of severe lower respiratory tract infection in infants, with the most severe cases concentrated among younger infants.MethodsHealthy pregnant women, at 28 weeks 0 days through 36 weeks 0 days of gestation, with an expected delivery date near the start of the RSV season, were randomly assigned in an overall ratio of approximately 2:1 to receive a single intramuscular dose of RSV fusion (F) protein nanoparticle vaccine or placebo. Infants were followed for 180 days to assess outcomes related to lower respiratory tract infection and for 364 days to assess safety. The primary end point was RSV-associated, medically significant lower respiratory tract infection up to 90 days of life, and the primary analysis of vaccine efficacy against the primary end point was performed in the per-protocol population of infants (prespecified criterion for success, lower bound of the 97.52% confidence interval [CI] of ≥30%).ResultsA total of 4636 women underwent randomization, and there were 4579 live births. During the first 90 days of life, the percentage of infants with RSV-associated, medically significant lower respiratory tract infection was 1.5% in the vaccine group and 2.4% in the placebo group (vaccine efficacy, 39.4%; 97.52% CI, -1.0 to 63.7; 95% CI, 5.3 to 61.2). The corresponding percentages for RSV-associated lower respiratory tract infection with severe hypoxemia were 0.5% and 1.0% (vaccine efficacy, 48.3%; 95% CI, -8.2 to 75.3), and the percentages for hospitalization for RSV-associated lower respiratory tract infection were 2.1% and 3.7% (vaccine efficacy, 44.4%; 95% CI, 19.6 to 61.5). Local injection-site reactions among the women were more common with vaccine than with placebo (40.7% vs. 9.9%), but the percentages of participants who had other adverse events were similar in the two groups.ConclusionsRSV F protein nanoparticle vaccination in pregnant women did not meet the prespecified success criterion for efficacy against RSV-associated, medically significant lower respiratory tract infection in infants up to 90 days of life. The suggestion of a possible benefit with respect to other end-point events involving RSV-associated respiratory disease in infants warrants further study. (Funded by Novavax and the Bill and Melinda Gates Foundation; ClinicalTrials.gov NCT02624947.).

Project description:ImportanceIn developed countries, bronchiolitis is the most common reason for infants to be admitted to the hospital, and all international bronchiolitis guidelines recommend supportive care; however, significant variation in practice continues with infants receiving non-evidence-based therapies. Deimplementation research aims to reduce the use of low-value care, and advancing science in this area is critical to delivering evidence-based care.ObjectiveTo determine the effectiveness of targeted interventions vs passive dissemination of an evidence-based bronchiolitis guideline in improving treatment of infants with bronchiolitis.Design, setting, and participantsThis international, multicenter cluster randomized clinical trial included 26 hospitals (clusters) in Australia and New Zealand providing tertiary or secondary pediatric care (13 randomized to intervention, 13 to control) during the 2017 bronchiolitis season. Data were collected on 8003 infants for the 3 bronchiolitis seasons (2014-2016) before the implementation period and 3727 infants for the implementation period (2017 bronchiolitis season, May 1-November 30). Data were analyzed from November 16, 2018, to December 9, 2020.InterventionsInterventions were developed using theories of behavior change to target key factors that influence bronchiolitis management. These interventions included site-based clinical leads, stakeholder meetings, a train-the-trainer workshop, targeted educational delivery, other educational and promotional materials, and audit and feedback.Main outcomes and measuresThe primary outcome was compliance during the first 24 hours of care with no use of chest radiography, albuterol, glucocorticoids, antibiotics, and epinephrine, measured retrospectively from medical records of randomly selected infants with bronchiolitis who presented to the hospital. There were no patient-level exclusions.ResultsA total of 26 hospitals were randomized without dropouts. Analysis was by intention to treat. Baseline data collected on 8003 infants for 3 bronchiolitis seasons (2014-2016) before the implementation period were similar between intervention and control hospitals. Implementation period data were collected on 3727 infants, including 2328 boys (62%) and 1399 girls (38%), with a mean (SD) age of 6.0 (3.2) months. A total of 459 (12%) were Māori (New Zealand), and 295 (8%) were Aboriginal/Torres Strait Islander (Australia). Compliance with recommendations was 85.1% (95% CI, 82.6%-89.7%) in intervention hospitals vs 73.0% (95% CI, 65.3%-78.8%) in control hospitals (adjusted risk difference, 14.1%; 95% CI, 6.5%-21.7%; P < .001).Conclusions and relevanceTargeted interventions led to improved treatment of infants with bronchiolitis. This study has important implications for bronchiolitis management and the development of effective interventions to deimplement low-value care.Trial registrationAustralian and New Zealand Clinical Trials Registry: ACTRN12616001567415.

Project description:BackgroundAs preterm infants' neurodevelopment is shaped by NICU-related factors during their hospitalization, it is essential to evaluate which interventions are more beneficial for their neurodevelopment at this specific time. The objective of this systematic review and meta-analysis was to evaluate the effectiveness of interventions initiated during NICU hospitalization on preterm infants' early neurodevelopment during their hospitalization and up to two weeks corrected age (CA).MethodsThis systematic review referred to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses [PRISMA] guidelines and was registered in PROSPERO (CRD42017047072). We searched CINAHL, MEDLINE, PubMed, EMBASE (OVID), Cochrane Systematic Reviews, CENTRAL, and Web of Science from 2002 to February 2020 and included randomized controlled/clinical trials conducted with preterm infants born between 24 and 366/7 weeks of gestation. All types of interventions instigated during NICU hospitalization were included. Two independent reviewers performed the study selection, data extraction, assessment of risks of bias and quality of evidence.ResultsFindings of 12 studies involving 901 preterm infants were synthesized. We combined three studies in a meta-analysis showing that compared to standard care, the NIDCAP intervention is effective in improving preterm infants' neurobehavioral and neurological development at two weeks CA. We also combined two other studies in a meta-analysis indicating that parental participation did not significantly improve preterm infants' neurobehavioral development during NICU hospitalization. For all other interventions (i.e., developmental care, sensory stimulation, music and physical therapy), the synthesis of results shows that compared to standard care or other types of comparators, the effectiveness was either controversial or partially effective.ConclusionsThe overall quality of evidence was rated low to very low. Future studies are needed to identify interventions that are the most effective in promoting preterm infants' early neurodevelopment during NICU hospitalization or close to term age. Interventions should be appropriately designed to allow comparison with previous studies and a combination of different instruments could provide a more global assessment of preterm infants' neurodevelopment and thus allow for comparisons across studies.Trial registrationProspero CRD42017047072 .

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Relative effectiveness of additive pain interventions during vaccination in infants.

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Relative effectiveness of additive pain interventions during vaccination in infants.

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