How effective is tetracaine 4% gel, before a peripherally inserted central catheter, in reducing procedural pain in infants: a randomized double-blind placebo controlled trial [ISRCTN75884221]

BACKGROUND: Procedural pain relief is sub-optimal in infants, especially small and vulnerable ones. Tetracaine gel 4% (Ametop(®), Smith-Nephew) provides pain relief in children and larger infants, but its efficacy in smaller infants and for peripherally inserted central catheters (PICC) remains uncertain. The objective of this trial was to assess the safety and efficacy of tetracaine gel on the pain response of very low birth weight (VLBW) infants during insertion of a PICC. METHODS: Medically stable infants greater than or equal to 24 weeks gestation, requiring a non-urgent PICC, were included. Following randomization and double blinding, 1.1 g of tetracaine or placebo was applied to the skin for 30 minutes. The PICC was inserted according to a standard protocol. Pain was assessed using the Premature Infant Pain Profile (PIPP). A 3-point change in the pain score was considered clinically significant, leading to a sample size of 54 infants, with 90% statistical power. Local skin reactions and immediate adverse cardiorespiratory events were noted. The primary outcome, PIPP score at 1 minute, was analysed using an independent Student's t-test. RESULTS: Fifty-four infants were included, 27 +/- 2 weeks gestation, 916 +/- 292 grams and 6.5 +/- 3.2 days of age. Baseline characteristics were similar between groups. The mean PIPP score in the first minute was 10.88 in the treatment group as compared to 11.74 in the placebo group (difference 0.86, 95% CI -1.86, 3.58). Median duration of crying in non-intubated infants was 181 seconds in the tetracaine group compared to 68 seconds in the placebo group (difference -78, 95% CI -539, 117). Local skin erythema was observed transiently in 4 infants (3 in the treatment and 1 in the placebo group). No serious harms were observed. CONCLUSION: Tetracaine 4% when applied for 30 minutes was not beneficial in decreasing procedural pain associated with a PICC in very small infants

How effective is tetracaine 4% gel, before a venipuncture, in reducing procedural pain in infants: a randomized double-blind placebo controlled trial

BACKGROUND: Procedural pain relief is sub-optimal in neonates. Topical tetracaine provides pain relief in children. Evidence of its efficacy and safety in neonates is limited. The objective of this study was to assess the efficacy and safety of topical tetracaine on the pain response of neonates during a venipuncture. METHODS: Medically stable infants greater than or equal to 24 weeks gestation, requiring a venipuncture, were included. Following randomization and double blinding, 1.1 g of tetracaine or placebo was applied to the skin for 30 minutes. Participants received oral sucrose if they met local eligibility criteria. The venipuncture was performed according to a standard protocol. A medium effect size in the pain score (corresponding to about 2 point difference in the PIPP score) was considered clinically significant, leading to a sample size of 142 infants, with 80% statistical power. Local skin reactions and immediate adverse cardiorespiratory events were noted. The primary outcome, PIPP score at 1 minute, was analysed using an independent Student's t-test. RESULTS: One hundred and forty two infants were included, 33 +/- 4 weeks gestation, 2100 +/- 900 grams and 6 +/- 3 days of age. There was almost no difference in PIPP scores at 1 minute between groups (mean difference -0.09; 95% confidence interval [CI]: -1.68 to 1.50; P = . 91). Similarly, there were no differences in PIPP scores during the 2(nd), 3(rd )and 4th minute. Duration of cry did not differ between the groups (median difference, 0; 95% CI, -3 to 0; P = . 84). The majority of infants in both groups received sucrose 24%. Sucrose had a significant effect on the PIPP score, as assessed by an ANOVA model (p = 0.0026). Local skin erythema was observed transiently in 11 infants (7 in the tetracaine and 4 in the placebo group). No serious side effect was observed. CONCLUSION: Tetracaine did not significantly decrease procedural pain in infants undergoing a venipuncture, when used in combination with routine sucrose administration

A randomized controlled trial of sucrose and/or pacifier as analgesia for infants receiving venipuncture in a pediatric emergency department

<p>Abstract</p> <p>Background</p> <p>Although sucrose has been accepted as an effective analgesic agent for procedural pain in neonates, previous studies are largely in the NICU population using the procedure of heel lance. This is the first report of the effect of sucrose, pacifier or the combination thereof for the procedural pain of venipuncture in infants in the pediatric emergency department population.</p> <p>Methods</p> <p>The study design was a double (sucrose) and single blind (pacifier), placebo-controlled randomized trial – factorial design carried out in a pediatric emergency department. The study population was infants, aged 0 – 6 months. Eighty-four patients were randomly assigned to one of four groups: a) sucrose b) sucrose & pacifier c) control d) control & pacifier. Each child received 2 ml of either 44% sucrose or sterile water, by mouth. The primary outcome measure: FLACC pain scale score change from baseline. Secondary outcome measures: crying time and heart rate change from baseline.</p> <p>Results</p> <p>Sucrose did not significantly reduce the FLACC score, crying time or heart rate. However sub-group analysis revealed that sucrose had a much greater effect in the younger groups. Pacifier use reduced FLACC score (not statistically significant), crying times (statistically significant) but not heart rate. Subgroup analysis revealed a mean crying time difference of 76.52 seconds (p < 0.0171) (0–1 month) and 123.9 seconds (p < 0.0029) (1–3 month). For subgroup age > 3 months pacifier did not have any significant effect on crying time. Age adjusted regression analysis revealed that both sucrose and pacifier had significant effects on crying time. Crying time increased with both increasing age and increasing gestational age.</p> <p>Conclusion</p> <p>Pacifiers are inexpensive, effective analgesics and are easy to use in the PED for venipuncture in infants aged 0–3 months. The benefits of sucrose alone as an analgesic require further investigation in the older infant, but sucrose does appear to provide additional benefit when used with a pacifier in this age group.</p> <p>Trial registration</p> <p>Current Controlled Trials ISRCTN15819627</p

Co-bedding as a Comfort measure For Twins undergoing painful procedures (CComForT Trial)

<p>Abstract</p> <p>Background</p> <p>Co-bedding, a developmental care strategy, is the practice of caring for diaper clad twins in one incubator (versus separating and caring for each infant in separate incubators), thus creating the opportunity for skin-to-skin contact and touch between the twins. In studies of mothers and their infants, maternal skin-to-skin contact has been shown to decrease procedural pain response according to both behavioral and physiological indicators in very preterm neonates. It is uncertain if this comfort is derived solely from maternal presence or from stabilization of regulatory processes from direct skin contact. The intent of this study is to compare the comfort effect of co-bedding (between twin infants who are co-bedding and those who are not) on infant pain response and physiologic stability during a tissue breaking procedure (heelstick).</p> <p>Methods/Design</p> <p>Medically stable preterm twin infants admitted to the Neonatal Intensive Care Unit will be randomly assigned to a co-bedding group or a standard care group. Pain response will be measured by physiological and videotaped facial reaction using the Premature Infant Pain Profile scale (PIPP). Recovery from the tissue breaking procedure will be determined by the length of time for heart rate and oxygen saturation to return to baseline. Sixty four sets of twins (n = 128) will be recruited into the study. Analysis and inference will be based on the intention-to-treat principle.</p> <p>Discussion</p> <p>If twin contact while co-bedding is determined to have a comforting effect for painful procedures, then changes in current neonatal care practices to include co-bedding may be an inexpensive, non invasive method to help maintain physiologic stability and decrease the long term psychological impact of procedural pain in this high risk population. Knowledge obtained from this study will also add to existing theoretical models with respect to the exact mechanism of comfort through touch.</p> <p>Trial registration</p> <p>NCT00917631</p

Acute Pain and a Motivational Pathway in Adult Rats: Influence of Early Life Pain Experience

The importance of neonatal experience upon behaviour in later life is increasingly recognised. The overlap between pain and reward pathways led us to hypothesise that neonatal pain experience influences reward-related pathways and behaviours in adulthood

Multidimensional pain assessment of preterm newborns at the 1st, 3rd and 7th days of life

CONTEXT AND OBJECTIVE: It is challenge to assess and treat pain in premature infants. The objective of this study was to compare the multidimensional pain assessment of preterm neonates subjected to an acute pain stimulus at 24 hours, 72 hours and seven days of life. DESIGN AND SETTING: Prospective cohort study, at Universidade Federal de São Paulo (UNIFESP). METHODS: Eleven neonates with gestational age less than 37 weeks that needed venepuncture for blood collection were studied. The exclusion criteria were Apgar score < 7 at five minutes, presence of any central nervous system abnormality, and discharge or death before seven days of life. Venepuncture was performed in the dorsum of the hand, and the heart rate, oxygen saturation and pain scales [Neonatal Facial Coding System (NFCS), Neonatal Infant Pain Scale (NIPS), and Premature Infant Pain Profile (PIPP)] were assessed at 24 hours, 72 hours and 7 days of life. NFCS and NIPS were evaluated prior to procedure (Tpre), during venepuncture (T0), and two (T2) and five (T5) minutes after needle withdrawal. Heart rate, O2 saturation and PIPP were measured at Tpre and T0. Mean values were compared by repeated-measurement analysis of variance. RESULTS: The pain parameters did not differ at 24 hours, 72 hours and 7 days of life: heart rate (p = 0.22), oxygen saturation (p = 0.69), NFCS (p = 0.40), NIPS (p = 0.32) and PIPP (p = 0.56). CONCLUSION: Homogeneous pain scores were observed following venepuncture in premature infants during their first week of life.CONTEXTO E OBJETIVO: É um desafio avaliar e tratar a dor do bebê prematuro. O objetivo deste estudo foi comparar, diante de um mesmo estímulo doloroso agudo, as respostas multidimensionais à dor obtidas ao longo da primeira semana de vida de prematuros. TIPO DE ESTUDO E LOCAL: Coorte prospectiva, na Universidade Federal de São Paulo (UNIFESP). MÉTODOS: Estudo de 11 neonatos com idade gestacional inferior a 37 semanas e necessidade de punção venosa para coleta de sangue, sendo excluídos aqueles com Apgar < 7 aos cinco minutos, alterações do sistema nervoso central e os que faleceram ou tiveram alta até sete dias de vida. A punção venosa foi feita no dorso da mão e avaliou-se a freqüência cardíaca, a saturação de oxigênio e as seguintes escalas de dor: NFCS (Neonatal Facial Coding System), NIPS (Neonatal Infant Pain Scale) e PIPP (Premature Infant Pain Profile) com 24, 72 horas e no sétimo dia de vida. A NFCS e a NIPS foram pontuadas antes da punção venosa (Tpré), durante (T0), dois (T2) e cinco (T5) minutos após. A freqüência cardíaca, a saturação de oxigênio e a PIPP foram analisadas em Tpré e T0. Compararam-se os valores médios das variáveis nos três momentos por análise de variância com medidas repetidas. RESULTADOS: Não houve diferenças no primeiro, terceiro e sétimo dias para freqüência cardíaca (p = 0,22), saturação de oxigênio (p = 0,69), NFCS (p = 0,40), NIPS (p = 0,32) e PIPP (p = 0,56). CONCLUSÃO: Houve homogeneidade da avaliação da dor causada por punção venosa em prematuros, ao longo da primeira semana de vida.Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)Universidade Federal de São Paulo (UNIFESP) Escola Paulista de Medicina Department of PediatricsUniversidade Federal de São Paulo (UNIFESP) Escola Paulista de Medicina Department of Preventive MedicineUNIFESP, EPM, Department of PediatricsUNIFESP, EPM, Department of Preventive MedicineCAPES: 1068-02SciEL