Pharmacological and combined interventions to reduce vaccine injection pain in children and adults systematic review and meta-analysis

Background: This systematic review assessed the effectiveness and safety of pharmacotherapy and combined interventions for reducing vaccine injection pain in individuals across the lifespan. Design/Methods: Electronic databases were searched for relevant randomized and quasi-randomized controlled trials. Self-reported pain and fear as well as observer-rated distress were critically important outcomes. Data were combined using standardized mean difference (SMD) or relative risk with 95% confidence intervals (CI). Results: Fifty-five studies that examined breastfeeding (which combines sweet-tasting solution, holding, and sucking), topical anesthetics, sweet-tasting solutions (sucrose, glucose), vapocoolants, oral analgesics, and combination of 2 versus 1 intervention were included. The following results report findings of analyses of critical outcomes with the largest number of participants. Compared with control, acute distress was lower for infants breastfed: (1) during vaccination (n=792): SMD -1.78 (CI, -2.35, -1.22) and (2) before vaccination (n=100): SMD -1.43 (CI, -2.14, -0.72). Compared with control/placebo, topical anesthetics showed benefit on acute distress in children (n=1424): SMD -0.91 (CI, -1.36, -0.47) and self-reported pain in adults (n=60): SMD -0.85 (CI, -1.38, -0.32). Acute and recovery distress was lower for children who received sucrose (n=2071): SMD -0.76 (CI, -1.19, -0.34) or glucose (n=818): SMD -0.69 (CI, -1.03, -0.35) compared with placebo/no treatment. Vapocoolants reduced acute pain in adults [(n=185), SMD -0.78 (CI, -1.08, -0.48)] but not children. Evidence from other needle procedures showed no benefit of acetaminophen or ibuprofen. The administration of topical anesthetics before and breastfeeding during vaccine injections showed mixed results when compared with topical anesthetics alone. There were no additive benefits of combining glucose and non-nutritive sucking (pacifier) compared with glucose or non-nutritive sucking (pacifier) alone or breastfeeding and sucrose compared with breastfeeding or sucrose alone. Conclusions: Breastfeeding, topical anesthetics, sweet-tasting solutions, and combination of topical anesthetics and breastfeeding demonstrated evidence of benefit for reducing vaccine injection pain in infants and children. In adults, limited data demonstrate some benefit of topical anesthetics and vapocoolants

Implementation Effectiveness of a Parent-Directed YouTube Video ("It Doesn't Have To Hurt") on Evidence-Based Strategies to Manage Needle Pain: Descriptive Survey Study

Background: Despite the availability of high-quality evidence and clinical practice guidelines for the effective management of pediatric pain, this evidence is rarely used in practice for managing children’s pain from needle procedures such as vaccinations. Parents are generally unaware of pain management strategies they can use with their children. Objective: This study aimed to develop, implement, and evaluate the implementation effectiveness of a parent-directed YouTube video on evidence-based strategies to manage needle pain in children. Methods: This was a descriptive study. Analytics were extracted from YouTube to describe video reach. A Web-based survey was used to seek parent and health care professional (HCP) feedback about the video. The 2-minute 18-second video was launched on YouTube on November 4, 2013. In the video, a 4-year-old girl tells parents what they should and should not do to help needles hurt less. The key evidence-based messages shared in the video were distraction, deep breathing, and topical anesthetic creams. A group of parents (n=163) and HCPs (n=278) completed the Web-based survey. Measures of reach included number of unique views, country where the video was viewed, sex of the viewer, and length of watch time. The Web-based survey assessed implementation outcomes of the video, such as acceptability, appropriateness, penetration, and adoption. Results: As of November 4, 2018 (5 years after launch), the video had 237,132 unique views from 182 countries, with most viewers watching an average of 55.1% (76/138 seconds) of the video. Overall, both parents and HCPs reported strong acceptance of the video (ie, they liked the video, found it helpful, and felt more confident) and reported significant improvements in plans to use distraction, deep breathing, and topical anesthetic creams. Conclusions: This parent-directed YouTube video was an acceptable and appropriate way to disseminate evidence about the procedure of pain management to a large number of parents

Exploring key elements of approaches that support childrens' preferences during painful and stressful medical procedures: A scoping review

PROBLEM: Children undergoing medical procedures can experience pain and distress. While numerous interventions exist to mitigate pain and distress, the ability to individualize the intervention to suit the needs and preferences of individual children is emerging as an important aspect of providing family-centered care and shared decision making. To date, the approaches for supporting children to express their preferences have not been systematically identified and described. A scoping review was conducted to identify such approaches and to describe the elements that are included in them. ELIGIBILITY CRITERIA: Studies that (a) described approaches with the aim to support children to express their coping preferences during medical procedures; (b) included the option for children to choose coping interventions; (c) included a child (1--18 years). SAMPLE: Searches were conducted in December 2019 and November 2020 in the following databases: Cinahl, Embase, PubMed and Psycinfo. RESULTS: Thirteen studies were identified that included six distinct approaches. Four important key elements were identified: 1) Aid to express preferences or choice, 2) Information Provision, 3) Assessment of feelings/emotions, 4) Feedback/Reflection and Reward. CONCLUSIONS: Identified approaches incorporate components of shared decision-making to support children in expressing their preferences during medical procedures and treatments. IMPLICATIONS: Children undergoing medical procedures can be supported in expressing their coping needs and preferences by using components of shared decision-making

Psychological interventions for vaccine injections in children and adolescents: Systematic review of randomized and quasi-randomized controlled trials

Background: This systematic review evaluated the effectiveness of psychological interventions for reducing vaccination pain and related outcomes in children and adolescents. Design/Methods: Database searches identified relevant randomized and quasi-randomized controlled trials. Data were extracted and pooled using established methods. Pain, fear, and distress were considered critically important outcomes. Results: Twenty-two studies were included; 2 included adolescents. Findings showed no benefit of false suggestion (n=240) for pain (standardized mean difference [SMD] -0.21 [-0.47, 0.05]) or distress (SMD -0.28 [-0.59, 0.11]), or for use of repeated reassurance (n=82) for pain (SMD -0.18 [-0.92, 0.56]), fear (SMD -0.18 [-0.71, 0.36]), or distress (SMD 0.10 [-0.33, 0.54]). Verbal distraction (n=46) showed reduced distress (SMD -1.22 [-1.87, -0.58]), but not reduced pain (SMD -0.27 [-1.02, 0.47]). Similarly, video distraction (n=328) showed reduced distress (SMD -0.58 [-0.82, -0.34]), but not reduced pain (SMD -0.88 [-1.78, 0.02]) or fear (SMD 0.08 [-0.25, 0.41]). Music distraction demonstrated reduced pain when used with children (n=417) (SMD -0.45 [-0.71, -0.18]), but not with adolescents (n=118) (SMD -0.04 [-0.42, 0.34]). Breathing with a toy (n=368) showed benefit for pain (SMD -0.49 [-0.85, -0.13]), but not fear (SMD -0.60 [-1.22, 0.02]); whereas breathing without a toy (n=136) showed no benefit for pain (SMD -0.27 [-0.61, 0.07]) or fear (SMD -0.36 [-0.86, 0.15]). There was no benefit for a breathing intervention (cough) in children and adolescents (n=136) for pain (SMD -0.17 [-0.41, 0.07]). Conclusions: Psychological interventions with some evidence of benefit in children include: verbal distraction, video distraction, music distraction, and breathing with a toy

HELPinKids & Adults knowledge synthesis of the management of vaccination pain and high levels of needle fear limitations of the evidence and recommendations for future research

The HELPinKids&Adults knowledge synthesis for the management of vaccination-related pain and high levels of needle fear updated and expanded upon the 2010 HELPinKIDS knowledge synthesis and clinical practice guideline for pain mitigation during vaccine injections in childhood. Interventions for vaccine pain management in adults and treatment of individuals with high levels of needle fear, phobias, or both were included, thereby broadening the reach of this work. The present paper outlines the overarching limitations of this diverse evidence base and provides recommendations for future research. Consistent with the framing of clinical questions in the systematic reviews, the Participants, Intervention, Comparison, Outcome, Study design (PICOAS) framework was used to organize these predominant issues and research directions. The major limitations we identified across systematic reviews were an overall dearth of trials on vaccination, lack of methodological rigor, failure to incorporate important outcomes, poor study reporting, and various sources of heterogeneity. Future research directions in terms of conducting additional trials in the vaccination context, improving methodological quality and rigor, assessment of global acceptability and feasibility of interventions, and inclusion of outcomes that stakeholders consider to be important (eg, compliance) are recommended. Given concerns about pain and fear are known contributors to vaccine hesitancy, improving and expanding this evidence base will be integral to broader efforts to improve vaccine compliance and public health worldwide

Process interventions for vaccine injections: Systematic review of randomized controlled trials and quasi-randomized controlled trials

Background: This systematic review evaluated the effectiveness of process interventions (education for clinicians, parent presence, education of parents [before and on day of vaccination], and education of patients on day of vaccination) on reducing vaccination pain, fear, and distress and increasing the use of interventions during vaccination. Design/Methods: Databases were searched using a broad search strategy to identify relevant randomized and quasi-randomized controlled trials. Critical outcomes were pain, fear, distress (when applicable), and use of pain management interventions. Data were extracted according to procedure phase (preprocedure, acute, recovery, combinations of these) and pooled using established methods. Analyses were conducted using standardized mean differences (SMD) and risk ratios (RR). Results: Thirteen studies were included. Results were generally mixed. On the basis of low to very low-quality evidence, the following specific critical outcomes showed significant effects suggesting: (1) clinicians should be educated about vaccine injection pain management (use of interventions: SMD 0.66; 95% confidence interval [CI]: 0.47, 0.85); (2) parents should be present (distress preprocedure: SMD -0.85; 95% CI: -1.35, -0.35); (3) parents should be educated before the vaccination day (use of intervention preprocedure: SMD 0.83; 95% CI: 0.25, 1.41 and RR, 2.08; 95% CI: 1.51, 2.86; distress acute: SMD, -0.35; 95% CI: -0.57, -0.13); (4) parents should be educated on the vaccination day (use of interventions: SMD 1.02; 95% CI: 0.22, 1.83 and RR, 2.42; 95% CI: 1.47, 3.99; distress preprocedure+acute+ recovery: SMD -0.48; 95% CI: -0.82, -0.15); and (5) individuals 3 years of age and above should be educated on the day of vaccination (fear preprocedure: SMD -0.67; 95% CI: -1.28, -0.07). Conclusions: Educating individuals involved in the vaccination procedure (clinicians, parents of children being vaccinated; individuals above 3 y of age) is beneficial to increase use of pain management strategies, reduce distress surrounding with vaccination, and to reduce fear. When possible, parent presence is also recommended for children undergoing vaccination

Procedural and physical interventions for vaccine injections systematic review of randomized controlled trials and quasi-randomized controlled trials

Background: This systematic review evaluated the effectiveness of physical and procedural interventions for reducing pain and related outcomes during vaccination. Design/Methods: Databases were searched using a broad search strategy to identify relevant randomized and quasi-randomized controlled trials. Data were extracted according to procedure phase (preprocedure, acute, recovery, and combinations of these) and pooled using established methods. Results: A total of 31 studies were included. Acute infant distress was diminished during intramuscular injection without aspiration (n=313): standardized mean difference (SMD) -0.82 (95% confidence interval [CI]: -1.18, -0.46). Injecting the most painful vaccine last during vaccinations reduced acute infant distress (n=196): SMD -0.69 (95%CI: -0.98, -0.4). Simultaneous injections reduced acute infant distress compared with sequential injections (n=172): SMD -0.56 (95%CI: -0.87, -0.25). There was no benefit of simultaneous injections in children. Less infant distress during the acute and recovery phases combined occurred with vastus lateralis (vs. deltoid) injections (n=185): SMD -0.70 (95%CI: -1.00, -0.41). Skin-to-skin contact in neonates (n=736) reduced acute distress: SMD -0.65 (95% CI: -1.05, -0.25). Holding infants reduced acute distress after removal of the data from 1 methodologically diverse study (n=107): SMD -1.25 (95% CI: -2.05, -0.46). Holding after vaccination (n=417) reduced infant distress during the acute and recovery phases combined: SMD -0.65 (95% CI: -1.08, -0.22). Self-reported fear was reduced for children positioned upright (n=107): SMD -0.39 (95% CI: -0.77, -0.01). Non-nutritive sucking (n=186) reduced acute distress in infants: SMD -1.88 (95% CI: -2.57, -1.18). Manual tactile stimulation did not reduce pain across the lifespan. An external vibrating device and cold reduced pain in children (n=145): SMD -1.23 (95% CI: -1.58, -0.87). There was no benefit of warming the vaccine in adults. Muscle tension was beneficial in selected indices of fainting in adolescents and adults. Conclusions: Interventions with evidence of benefit in select populations include: no aspiration, injecting most painful vaccine last, simultaneous injections, vastus lateralis injection, positioning interventions, non-nutritive sucking, external vibrating device with cold, and muscle tension

Simple psychological interventions for reducing pain from common needle procedures in adults: Systematic review of randomized and quasi-randomized controlled trials

Background: This systematic review evaluated the effectiveness of simple psychological interventions for managing pain and fear in adults undergoing vaccination or related common needle procedures (ie, venipuncture/venous cannulation). Design/Methods: Databases were searched to identify relevant randomized and quasi-randomized controlled trials. Self-reported pain and fear were prioritized as critically important outcomes. Data were combined using standardized mean difference (SMD) or relative risk (RR) with 95% confidence intervals (CI). Results: No studies involving vaccination met inclusion criteria; evidence was drawn from 8 studies of other common needle procedures (eg, venous cannulation, venipuncture) in adults. Two trials evaluating the impact of neutral signaling of the impending procedure (eg, ready? ) as compared with signaling of impending pain (eg, sharp scratch ) demonstrated lower pain when signaled about the procedure (n=199): SMD=-0.97 (95% CI, -1.26, -0.68), after removal of 1 trial where self-reported pain was significantly lower than the other 2 included trials. Two trials evaluated music distraction (n=156) and demonstrated no difference in pain: SMD=0.10 (95% CI, -0.48, 0.27), or fear: SMD= -0.25 (95% CI, -0.61, 0.10). Two trials evaluated visual distraction and demonstrated no difference in pain (n=177): SMD= -0.57 (95% CI, -1.82, 0.68), or fear (n=81): SMD= -0.05 (95% CI, -0.50, 0.40). Two trials evaluating breathing interventions found less pain in intervention groups (n=138): SMD= -0.82 (95% CI, -1.21, -0.43). The quality of evidence across all trials was very low. Conclusions: There are no published studies of simple psychological interventions for vaccination pain in adults. There is some evidence of a benefit from other needle procedures for breathing strategies and neutral signaling of the start of the procedure. There is no evidence for use of music or visual distraction

Interventions for individuals with high levels of needle fear: Systematic review of randomized controlled trials and quasi-randomized controlled trials

Background: This systematic review evaluated the effectiveness of exposure-based psychological and physical interventions for the management of high levels of needle fear and/or phobia and fainting in children and adults. Design/Methods: A systematic review identified relevant randomized and quasi-randomized controlled trials of children, adults, or both with high levels of needle fear, including phobia (if not available, then populations with other specific phobias were included). Critically important outcomes were self-reported fear specific to the feared situation and stimulus (psychological interventions) or fainting (applied muscle tension). Data were pooled using standardized mean difference (SMD) or relative risk with 95% confidence intervals. Results: The systematic review included 11 trials. In vivo exposurebased therapy for children 7 years and above showed benefit on specific fear (n=234; SMD: -1.71 [95% CI: -2.72, -0.7]). In vivo exposure-based therapy with adults reduced fear of needles posttreatment (n=20; SMD: -1.09 [-2.04, -0.14]) but not at 1-year follow-up (n=20; SMD: -0.28 [-1.16, 0.6]). Compared with single session, a benefit was observed for multiple sessions of exposure-based therapy posttreatment (n=93; SMD: -0.66 [-1.08, -0.24]) but not after 1 year (n=83; SMD: -0.37 [-0.87, 0.13]). Non in vivo e.g., imaginal exposure-based therapy in children reduced specific fear posttreatment (n=41; SMD: -0.88 [-1.7, -0.05]) and at 3 months (n=24; SMD: -0.89 [-1.73, -0.04]). Non in vivo exposure-based therapy for adults showed benefit on specific fear (n=68; SMD: -0.62 [-1.11, -0.14]) but not procedural fear (n=17; SMD: 0.18 [-0.87, 1.23]). Applied tension showed benefit on fainting posttreatment (n=20; SMD: -1.16 [-2.12, -0.19]) and after 1 year (n=20; SMD: -0.97 [-1.91, -0.03]) compared with exposure alone. Conclusions: Exposure-based psychological interventions and applied muscle tension show evidence of benefit in the reduction of fear in pediatric and adult populations