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1.
Vaccine ; 40(52): 7667-7675, 2022 12 12.
Article in English | MEDLINE | ID: mdl-36372667

ABSTRACT

This study examined perceptions of children and parents about a new web-based CARD (Comfort, Ask, Relax, Distract) game that teaches children how to cope with needle-related pain and fear. A convenience sample of 15 child-parent dyads (children, 6-12 years) participated. Children played the game on a handheld device while being virtually monitored. Activity tracking revealed most children engaged with multiple components. Children reported they understood the game, it was easy to play, they learned coping strategies and believed they could implement them. Children reported lower fear of needles after playing. Parents liked the simplicity and variety of game activities. Most children and parents reported they would use the game or its coping strategies for future needles and would recommend the game. In summary, children and parents found the CARD web game acceptable and appropriate. Future studies can evaluate its effectiveness when integrated into upcoming needle procedures like COVID-19 vaccinations.


Subject(s)
COVID-19 , Needles , Humans , Fear , Pain , Adaptation, Psychological
2.
J Pain ; 18(9): 1060-1066, 2017 09.
Article in English | MEDLINE | ID: mdl-28455250

ABSTRACT

The objective was to determine if consistent pain management during vaccine injections has a beneficial effect on future infant pain reactivity. This was a multicenter, longitudinal, double-blind, double-dummy, add-on, randomized controlled trial. Healthy infants were randomized to 1 of 4 add-on pain management regimens for all vaccinations in the first year of life: 1) placebo control (standard care), 2) parent video education about infant soothing (video), 3) video and oral sucrose solution (sucrose), 4) video and sucrose and topical liposomal lidocaine (lidocaine). At 15-month vaccinations, all active pain interventions were administered (video and sucrose and lidocaine); however, individuals remained blinded to the original treatments given. Pain at 15 months was evaluated during 3 procedure phases (baseline, needle injection, and recovery) by a researcher unaware of group allocation using a validated measure, the Modified Behavioural Pain Scale (range, 0-10). Altogether, 352 infants participated; characteristics did not differ among groups (P > .05). Pain scores did not differ among groups during baseline (P = .642), needle injection (P = .739), or recovery (P = .750) phases. In conclusion, there was no evidence of a long-term benefit of consistent use of pain interventions in the first year of life on future infant pain responsivity at 15-month vaccinations. PERSPECTIVE: This randomized controlled trial did not find a long-term benefit of consistent pain management during infant vaccinations on future infant pain responsivity at 15 months. The results are relevant to clinicians and researchers studying and evaluating pain interventions in children undergoing medical procedures.


Subject(s)
Pain Management , Stress, Psychological/prevention & control , Vaccination/psychology , Ambulatory Care/methods , Analysis of Variance , Anesthetics, Local/administration & dosage , Dietary Sucrose , Double-Blind Method , Education, Nonprofessional , Female , Humans , Infant , Lidocaine/administration & dosage , Longitudinal Studies , Male , Pain Management/methods , Patient Education as Topic , Treatment Failure , Vaccination/methods
4.
CMAJ ; 189(6): E227-E234, 2017 Feb 13.
Article in English | MEDLINE | ID: mdl-27956393

ABSTRACT

BACKGROUND: 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. METHODS: 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. RESULTS: 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). INTERPRETATION: Only liposomal lidocaine provided consistent analgesia within an additive pain intervention regimen during vaccinations in infants. Trial registration: ClinicalTrials.gov, no. NCT01503060.


Subject(s)
Acute Pain/prevention & control , Anesthetics, Local/therapeutic use , Injections/adverse effects , Lidocaine/therapeutic use , Parents/education , Sucrose/therapeutic use , Sweetening Agents/therapeutic use , Vaccines/administration & dosage , Acute Pain/etiology , Administration, Cutaneous , Audiovisual Aids , Double-Blind Method , Female , Humans , Infant , Infant Care/methods , Liposomes , Longitudinal Studies , Male , Pain Management , Pain Measurement
5.
Vaccine ; 34(39): 4672-4677, 2016 09 07.
Article in English | MEDLINE | ID: mdl-27527817

ABSTRACT

OBJECTIVE: This study compared the pain caused from fast vs. slow vaccine injections. METHODS: Infants aged 2-6months receiving primary immunizations were randomized to fast (2-4mL/s) or slow (5-10mL/s) injections during routine 0.5mL Diphtheria, Tetanus, acellular Pertussis, Inactivated Polio Virus, Haemophilus influenzae type b vaccine (DTaP-IPV-Hib) injections. Those aged 2 and 4months additionally received 0.5mL Pneumococcal Conjugate Vaccine (PCV) injections. A research assistant and parent unaware of treatment allocation and hypothesis assessed pain using validated and recommended tools, including; the Modified Behavioural Pain Scale (MBPS, range 0-10), cry duration, and Numerical Rating Scale (NRS, range 0-10). The primary outcome was infant pain score using the MBPS. RESULTS: Altogether, 120 were recruited; 61 were randomized to fast injections and 59 to slow injections. One hundred and ninteen infants participated. There were no differences in characteristics, including; age (p=0.994) and sex (p=0.540). The mean MPBS score (standard deviation) during DTaP-IPV-Hib injection was lower in the fast injection group: 6.4 (2.7) vs. 7.4 (2.5), respectively; p=0.046. Regression analysis demonstrated a positive correlation between injection speed and pain. There were no other differences between groups. CONCLUSION: Fast injection reduced injection-induced pain in infants receiving DTaP-IPV-Hib but not PCV vaccine. Fast injections are recommended when administering vaccines because of the potential for a reduction in pain, feasibility and practicality. TRIAL REGISTRATION: NCT02504398.


Subject(s)
Acute Pain/etiology , Injections, Intramuscular/adverse effects , Injections, Intramuscular/methods , Vaccination/adverse effects , Vaccination/methods , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Female , Haemophilus Vaccines/adverse effects , Humans , Infant , Male , Pain Measurement , Pain, Procedural/etiology , Pneumococcal Vaccines/adverse effects , Poliovirus Vaccine, Inactivated/adverse effects , Vaccines, Conjugate/adverse effects
6.
Cogn Behav Ther ; 45(3): 217-35, 2016 Apr.
Article in English | MEDLINE | ID: mdl-27007463

ABSTRACT

Needle fear typically begins in childhood and represents an important health-related issue across the lifespan. Individuals who are highly fearful of needles frequently avoid health care. Although guidance exists for managing needle pain and fear during procedures, the most highly fearful may refuse or abstain from such procedures. The purpose of a clinical practice guideline (CPG) is to provide actionable instruction on the management of a particular health concern; this guidance emerges from a systematic process. Using evidence from a rigorous systematic review interpreted by an expert panel, this CPG provides recommendations on exposure-based interventions for high levels of needle fear in children and adults. The AGREE-II, GRADE, and Cochrane methodologies were used. Exposure-based interventions were included. The included evidence was very low quality on average. Strong recommendations include the following. In vivo (live/in person) exposure-based therapy is recommended (vs. no treatment) for children seven years and older and adults with high levels of needle fear. Non-in vivo (imaginal, computer-based) exposure (vs. no treatment) is recommended for individuals (over seven years of age) who are unwilling to undergo in vivo exposure. Although there were no included trials which examined children < 7 years, exposure-based interventions are discussed as good clinical practice. Implementation considerations are discussed and clinical tools are provided. Utilization of these recommended practices may lead to improved health outcomes due to better health care compliance. Research on the understanding and treatment of high levels of needle fear is urgently needed; specific recommendations are provided.


Subject(s)
Fear/psychology , Implosive Therapy/methods , Needles , Phobic Disorders/therapy , Adult , Child , Humans , Phobic Disorders/psychology
7.
Clin J Pain ; 31(10 Suppl): S20-37, 2015 Oct.
Article in English | MEDLINE | ID: mdl-26352919

ABSTRACT

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.


Subject(s)
Pain Management , Pain , Physical Therapy Modalities , Randomized Controlled Trials as Topic , Vaccination , Humans , Pain/etiology , Pain/prevention & control , Physical Examination , Vaccination/adverse effects
9.
Vaccine ; 33(25): 2939-43, 2015 Jun 09.
Article in English | MEDLINE | ID: mdl-25917674

ABSTRACT

OBJECTIVE: Sucrose solutions are analgesic in infants. Oral rotavirus vaccine contains sucrose, however, it is not known if it possesses analgesic properties. The objective was to compare the analgesic effectiveness of rotavirus vaccine to sucrose solution when administered prior to injectable vaccines. METHODS: Infants 2-4 months of age receiving oral rotavirus vaccine and two separate injectable vaccines on the same day were randomized to rotavirus vaccine (Rotarix) first followed by the injectable vaccines and sucrose (Tootsweet) afterwards, or vice versa. Pain was assessed by blinded raters using the Numerical Rating Scale (NRS, range 0-10) (parents, clinicians), or Modified Behavioural Pain Scale (MBPS, range 0-10) and cry duration (observers). Data were analyzed using t-tests or χ(2)-tests; Bonferroni correction was applied to correct for multiple comparisons, as appropriate. RESULTS: Altogether, 120 infants participated: 60 were randomized to rotavirus vaccine first. Groups did not differ in demographics, including; age (p=0.448) and sex (p=0.464). The mean pain score (standard deviation) for both vaccine injections did not differ between infants given rotavirus vaccine first versus sucrose solution first: observer MBPS, parent NRS and clinician NRS scores were 7.4 (1.6) vs. 7.7 (1.6), 4.9 (2.1) vs. 5.8 (2.1), and 4.2 (2.1) vs. 4.6 (2.2), respectively. Similarly, there was no difference between groups in cry duration. CONCLUSION: Rotavirus vaccine did not differ from sucrose solution in reducing injection-induced pain. Based on the findings, it is recommended that rotavirus vaccine be administered prior to injectable vaccines in infants aged 2 and 4 months.


Subject(s)
Analgesics/administration & dosage , Pain/prevention & control , Rotavirus Vaccines/administration & dosage , Sucrose/administration & dosage , Vaccination , Administration, Oral , Female , Healthy Volunteers , Humans , Infant , Injections, Intramuscular , Male , Pain Measurement , Parents , Vaccines, Attenuated/administration & dosage
10.
BMC Med Educ ; 15: 45, 2015 Mar 12.
Article in English | MEDLINE | ID: mdl-25881321

ABSTRACT

BACKGROUND: Adapting educational tools to meet user needs is a critical aspect of translating research evidence into best clinical practices. The objectives of this study were to evaluate usability and effectiveness of educational tools about infant vaccination pain management directed to postnatal nurses. METHODS: Mixed methods design. A template pamphlet and video included in a published clinical practice guideline were subjected to heuristic usability evaluation and then the revised tools were reviewed by postnatal hospital nurses in three rounds of interviews involving 8 to 12 nurses per round. Nurses' knowledge about evidence-based pain management interventions was evaluated at three time points: baseline, after pamphlet review, and after video review. RESULTS: Of 32 eligible postnatal nurses, 29 agreed to participation and data were available for 28. Three overarching themes were identified in the interviews: 1) utility of information, 2) access to information, and 3) process for infant procedures. Nurses' knowledge improved significantly (p < 0.05) from the baseline phase to the pamphlet review phase, and again from the pamphlet review phase to the video review phase. CONCLUSIONS: This study demonstrated usability and knowledge uptake from a nurse-directed educational pamphlet and video about managing infant vaccination pain. Future studies are needed to determine the impact of implementing these educational tools in the postnatal hospital setting on parental utilization of analgesic interventions during infant hospitalization and future infant vaccinations.


Subject(s)
Neonatal Nursing/education , Pain Management/nursing , Teaching Materials/standards , Vaccination/nursing , Educational Measurement , Humans , Infant, Newborn
11.
Clin J Pain ; 30(11): 987-94, 2014 Nov.
Article in English | MEDLINE | ID: mdl-24300222

ABSTRACT

OBJECTIVE: To evaluate knowledge uptake from a parent-directed factsheet about managing pain during infant vaccinations, and the added influence of a pretest. MATERIALS AND METHODS: Solomon 4-group randomized controlled trial. New mothers hospitalized after the birth of an infant were randomized to 1 of 4 groups: 2 included the intervention (factsheet about pain management) and 2 included the control (information on another topic). A pretest was given to 1 intervention and 1 control group. Following maternal review of allocated information, posttests were administered in all groups. Both control groups received the information after posttesting. A follow-up telephone survey after 2 months measured knowledge retention and utilization of pain management interventions. RESULTS: A total of 120 mothers participated (July, 2012 to February, 2013); demographics did not differ among groups. The 2 factsheet groups demonstrated more knowledge (P<0.05) about effective pain management (mean without pretest: 5.6 [SD=2.0]; with pretest: 6.9 [1.6]) compared with the 2 control groups (without pretest: 3.2 [2.2]; with pretest: 3.4 [2.5]) immediately after review; and the factsheet and pretest group scored higher than the factsheet only group. In groups with a prefactsheet baseline knowledge test, knowledge was higher at follow-up compared with baseline. Follow-up knowledge and utilization of pain management interventions did not differ among groups. CONCLUSIONS: The factsheet led to acute gains in knowledge and knowledge gains persisted after 2 months. Acutely, knowledge was bolstered by the pretest. These results can be used to guide future research and implementation of the factsheet.


Subject(s)
Health Knowledge, Attitudes, Practice , Mothers , Pain Management/methods , Patient Education as Topic/methods , Vaccination/adverse effects , Vaccination/methods , Adult , Analysis of Variance , Evidence-Based Medicine , Female , Follow-Up Studies , Humans , Infant , Infant, Newborn , Male , Parents
12.
BMC Pediatr ; 13: 23, 2013 Feb 08.
Article in English | MEDLINE | ID: mdl-23394070

ABSTRACT

BACKGROUND: Although numerous evidence-based and feasible interventions are available to treat pain from childhood vaccine injections, evidence indicates that children are not benefitting from this knowledge. Unrelieved vaccination pain puts children at risk for significant long-term harms including the development of needle fears and subsequent health care avoidance behaviours. Parents report that while they want to mitigate vaccination pain in their children, they lack knowledge about how to do so. An evidence-based clinical practice guideline for managing vaccination pain was recently developed in order to address this knowledge-to-care gap. Educational tools (pamphlet and video) for parents were included to facilitate knowledge transfer at the point of care. The objectives of this study were to evaluate usability and effectiveness in terms of knowledge acquisition from the pamphlet and video in parents of newly born infants. METHODS: Mixed methods design. Following heuristic usability evaluation of the pamphlet and video, parents of newborn infants reviewed revised versions of both tools and participated in individual and group interviews and individual knowledge testing. The knowledge test comprised of 10 true/false questions about the effectiveness of various pain management interventions, and was administered at three time points: at baseline, after review of the pamphlet, and after review of the video. RESULTS: Three overarching themes were identified from the interviews regarding usability of these educational tools: receptivity to learning, accessibility to information, and validity of information. Parents' performance on the knowledge test improved (p≤0.001) from the baseline phase to after review of the pamphlet, and again from the pamphlet review phase to after review of the video. CONCLUSIONS: Using a robust testing process, we demonstrated usability and conceptual knowledge acquisition from a parent-directed educational pamphlet and video about management of vaccination pain. Future studies are planned to determine the impact of these educational tools when introduced in clinical settings on parent behaviors during infant vaccinations.


Subject(s)
Consumer Health Information/methods , Health Knowledge, Attitudes, Practice , Pain Management/methods , Pamphlets , Parents/education , Vaccination , Video Recording , Adult , Child , Child, Preschool , Female , Humans , Infant , Interviews as Topic , Male , Practice Guidelines as Topic , Qualitative Research
13.
Vaccine ; 30(32): 4807-12, 2012 Jul 06.
Article in English | MEDLINE | ID: mdl-22617633

ABSTRACT

Needle fears are a documented barrier to immunization in children and adults. There is a paucity of data, however, regarding the prevalence of needle fears and their impact on immunization compliance. In this cross-sectional survey, a convenience sample of parents (n=883) and children (n=1024) attending a public museum in Toronto, Canada answered questions about needle fears and non-compliance with immunization due to needle fear. Altogether, 24% of parents and 63% of children reported a fear of needles. Needle fear was the primary reason for immunization non-compliance for 7% and 8% of parents and children, respectively. Interventions aimed at improving education about, and access to, analgesic interventions during immunization injections performed in childhood are recommended in order to prevent the development of needle fears and vaccine non-compliance.


Subject(s)
Fear , Needles , Patient Compliance/psychology , Vaccination/psychology , Adolescent , Adult , Canada , Child , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Pain/prevention & control , Prevalence , Vaccination/methods
14.
Clin J Pain ; 28(3): 238-42, 2012.
Article in English | MEDLINE | ID: mdl-21904197

ABSTRACT

OBJECTIVE: Pain from vaccine injections remains undertreated, despite the availability of numerous pain-relieving strategies. Healthcare providers report lack of time within current office workflows as a major barrier to routine pain management. The objective was to document the total time involved in outpatient vaccine appointments to test the hypothesis that offering pain-relieving strategies can be practically implemented when considering the element of time to vaccine injection. PATIENTS AND METHODS: Prospective naturalistic study in 8 urban outpatient primary care clinics (4 pediatric and 4 family practice) in Toronto. For 48 to 59 consecutive childhood vaccination appointments at each site, child waiting time from clinic arrival until first vaccine injection was tracked. RESULTS: Altogether, 405 vaccine appointments were included. The median age of the child undergoing vaccination was 12 months. The mean (SD) time from clinic arrival until first vaccine injection was 41.6 minutes (20.9), with a range of 7 to 132 minutes. Linear regression identified a significant (P<0.05) difference according to clinic [ranging from 19.4 min (6.5) to 57.5 min (20.2)] and number of family members in the appointment [ranging from 40.6 min (21.0) for an appointment in the index child only to 50 min (14.3) for an appointment in the index child and 2 other family members]. CONCLUSIONS: Contrary to healthcare provider perceptions, the timing of outpatient childhood vaccine appointments allows for the inclusion of pain management interventions. Efforts should now focus on educating healthcare providers and parents about the value of pain management and how to implement evidence-based strategies.


Subject(s)
Pain Management , Pain/etiology , Parents/psychology , Vaccination/adverse effects , Adolescent , Ambulatory Care Facilities , Child , Child, Preschool , Female , Humans , Infant , Infant, Newborn , Linear Models , Male , Pain/prevention & control , Time Factors , Tornadoes
15.
Acad Pediatr ; 11(1): 66-74, 2011.
Article in English | MEDLINE | ID: mdl-21272826

ABSTRACT

OBJECTIVE: The pandemic influenza H1N1 2009 (pH1N1) virus is expected to remain a prominent circulating strain in the current and subsequent influenza seasons. The objective of this study was to compare the clinical course of infection with laboratory-confirmed pH1N1 and seasonal influenza A and B in a cohort of previously healthy children managed in the outpatient setting without antiviral therapy. METHODS: Previously healthy children 17 years of age or younger were prospectively enrolled during the first wave of the 2009 pandemic (May-July 2009) and the 2 preceding influenza seasons from a single primary care physician office and a tertiary children's hospital emergency department. Inclusion criteria were: age ≤17 years; laboratory-confirmed influenza; and not receiving antiviral agents. Follow-up telephone interviews were conducted approximately 2 days and 14 days after presentation to assess symptom duration. RESULTS: A total of 251 patients (101 with pH1N1, 90 with seasonal influenza A, 60 with seasonal influenza B) were included. Presenting symptoms and duration of symptoms associated with pH1N1 were similar to those with seasonal influenza. Median fever duration in pH1N1 was 3 days and had resolved within 8 days in 95% of patients. Among patients with pH1N1, abnormalities on chest auscultation (10 of 101), the hospitalization rate (2 of 101), the proportion of children receiving intravenous fluid therapy (1 of 101) or supplemental oxygen (1 of 101) were not significantly different from patients with seasonal influenza. CONCLUSIONS: In most children without underlying risk factors for severe influenza, pH1N1 virus causes an uncomplicated respiratory tract illness, no more severe than seasonal influenza.


Subject(s)
Influenza, Human/diagnosis , Adolescent , Child , Child, Preschool , Emergency Service, Hospital , Female , Hospitals, Pediatric , Humans , Infant , Influenza A Virus, H1N1 Subtype/isolation & purification , Influenza B virus/isolation & purification , Influenza, Human/epidemiology , Influenza, Human/therapy , Interviews as Topic , Male , Ontario/epidemiology , Pandemics , Pediatrics , Primary Health Care , Prospective Studies , Treatment Outcome
16.
Vaccine ; 29(7): 1390-4, 2011 Feb 04.
Article in English | MEDLINE | ID: mdl-21195076

ABSTRACT

There is a need to identify a primary measure of infant pain that can be used to assess pain in infants undergoing vaccine injections in order to facilitate vaccine outcomes research. The aim of the present study was to determine the reliability, validity and practicality of 3 measures of acute pain in infants; the Modified Behavioural Pain Scale (MBPS), Neonatal Infant Pain Scale (NIPS), and Face Legs Activity Cry Consolability Scale (FLACC). Five raters rated pain from videotapes in 120 infants aged 2-6 months undergoing vaccine injections that participated in a randomized controlled trial designed to compare pain responses between two vaccines, DPTaP-Hib vaccine and PCV vaccine. Inter-rater reliability coefficients for baseline and vaccine injections were all greater than 0.85. Cronbach's alpha ranged from 0.83 to 0.94. Construct validity was demonstrated for all measures by vaccine injection scores that were higher (p<0.001) than baseline scores and by PCV scores that were higher than DPTaP-Hib scores. Concurrent validity was demonstrated by bi-variate correlation coefficients that ranged from 0.84 to 0.92. Intra-rater reliability coefficients for scores obtained after a single viewing (simulating real time assessment) versus multiple viewings were ≥ 0.96. All measures demonstrated a significant difference in pain scores between the more painful (PCV) and less painful (DPTaP-Hib) vaccine for scores obtained after a single viewing. The majority of raters (4 out of 5) preferred the MBPS. Together, these results provide preliminary support for the MBPS as the primary outcome of pain during vaccine injections in infants.


Subject(s)
Immunization/adverse effects , Injections/adverse effects , Pain Measurement/methods , Female , Humans , Infant , Male , Randomized Controlled Trials as Topic , Reproducibility of Results , Video Recording
19.
Pediatrics ; 125(3): e639-44, 2010 Mar.
Article in English | MEDLINE | ID: mdl-20156906

ABSTRACT

BACKGROUND: The rapidly evolving pandemic of novel 2009 swine-origin influenza A (H1N1) virus (S-OIV) demands that accurate and practical diagnostics be urgently evaluated for their potential clinical utility. OBJECTIVE: To determine the diagnostic accuracy of a rapid influenza diagnostic test (RIDT) and direct fluorescent antibody (DFA) assay for S-OIV by using reverse-transcription polymerase chain reaction (RT-PCR) as the reference standard. METHODS: We prospectively recruited children (aged 0-17 years) assessed in the emergency department of a pediatric referral hospital and a community pediatric clinic for influenza-like illness between May 22 and July 25, 2009. RIDT (performed on-site) and DFA were compared with RT-PCR to determine their sensitivity and specificity for S-OIV. We also compared the sensitivity of RIDT for S-OIV to that for seasonal influenza over 2 preceding seasons. RESULTS: Of 820 children enrolled, 651 were from the emergency department and 169 were from the clinic. RIDT sensitivity was 62% (95% confidence interval [CI]: 52%-70%) for S-OIV, with a specificity of 99% (95% CI: 92%-100%). DFA sensitivity was 83% (95% CI: 75%-89%) and was superior to that of RIDT (P < .001). RIDT sensitivity for S-OIV was comparable to that for seasonal influenza when using DFA supplemented with culture as the reference standard. RIDT sensitivity for influenza viruses was significantly higher in children 5 years of age or younger (P = .003) and in patients presenting < or =2 days after symptom onset (P < .001). CONCLUSIONS: The sensitivity of RIDT for detection of S-OIV is higher than recently reported in mixed adult-pediatric populations but remains suboptimal.


Subject(s)
Influenza, Human/diagnosis , Adolescent , Child , Child, Preschool , Diagnostic Tests, Routine/standards , Humans , Infant , Prospective Studies , Sensitivity and Specificity , Time Factors
20.
Clin Ther ; 31 Suppl 2: S152-67, 2009.
Article in English | MEDLINE | ID: mdl-19781434

ABSTRACT

BACKGROUND: Immunization is regarded as one of the most significant medical achievements of all time. Recently, increasing attention has been paid to the pain resulting from routine childhood immunizations. OBJECTIVE: This narrative review summarizes existing knowledge about: (1) the epidemiology of childhood immunization pain; (2) the pain experience of children undergoing immunization; (3) current analgesic practices; (4) barriers to practicing pain management in children; and (5) recommendations for improvements in pain management during immunization. METHODS: We conducted a search of MEDLINE, PsycINFO, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials for primary research and review articles published from inception of the databases through October 2008. Key search terms included immunization, pain, child/infant, vaccine, and intervention. Additional studies were identified through searches of the reference lists in the retrieved articles. No language restrictions were imposed regarding the type of article (eg, full article, abstract) or language. RESULTS: Vaccine injections are the most common iatrogenic procedure performed in childhood and a major source of distress for children (of all ages), their parents, and the participating health care professionals, as well as a direct cause of vaccine nonadherence. In addition, lack of adequate pain management during immunization exposes children to unnecessary suffering and the potential for long-term consequences, such as fear of needles. Numerous pain management strategies are available to reduce vaccine injection pain, including: (1) physical interventions and injection techniques; (2) psychological interventions; and (3) phar-macologic and combined interventions. However, adoption of pain-relieving techniques into clinical practice has been suboptimal. The underutilization of pain management strategies can be attributed to a lack of knowledge about pain and effective pain prevention strategies, and the persistence of attitudes about pain that interfere with optimal clinical practices. Current analgesic practices could be improved substantially if all stakeholders involved in immunization (eg, policy makers, practitioners, consumers) participate in efforts to reduce pain. Treating pain during childhood immunization has the potential to reduce distress during the procedure and greatly improve satisfaction with the immunization experience through more positive experiences for children and their families. Other potential benefits include improved adherence to immunization schedules and reduced sequelae of untreated pain. CONCLUSION: Immunization is a global health priority. Medical care can be improved if pain management becomes a routine aspect of the delivery of vaccine injections.


Subject(s)
Immunization/adverse effects , Injections/adverse effects , Pain/etiology , Pain/prevention & control , Analgesia , Child , Child, Preschool , Humans , Infant , Pain/epidemiology , Patient Compliance
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