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A Taddio

Publications and source records attributed to A Taddio.

At least 19 recordsLinked to original sources

Use of antidepressants by pregnant women: evaluation of perception of risk, efficacy of evidence based counseling and determinants of decision making.

BACKGROUND: The World Health Organization predicts that by 2012, depression will be the number one disease in the world. Thus, many women who become pregnant will require treatment with antidepressants. We are aware that women and their health care providers remain hesitant to prescribe and take these drugs during pregnancy, despite evidence of the relative safety. OBJECTIVES: 1) To determine perception of risk of antidepressant drugs by pregnant women with depression, 2) to determine the efficacy of evidence-based counseling, and 3) to identify determinants that influence women in their decision making regarding the continuation/discontinuation of antidepressants during pregnancy. METHODS: Women who called The Motherisk Program requesting information about the safety of an antidepressant during pregnancy were compared with two other groups: 1) Women who called about antibiotic use (i.e., non-teratogenic drugs used short-term) and 2) women who called about gastric medications (i.e., non-teratogenic drugs used long-term). Their perception of risk was measured before and after evidenced-based information was given and determinants of decision making was also evaluated. RESULTS: We recruited 100 women taking antidepressants during pregnancy and 100 in each comparison group. Despite receiving evidence-based reassuring information, 15% of antidepressant users, compared to 4% using gastric drugs and 1% using antibiotics, chose to discontinue their medication. The main determinants of decision making were based on: information received prior to calling Motherisk, family and friends advice, the internet, sequence of advice given and if a women was undecided at the time of call. CONCLUSIONS: Women continue to fear taking antidepressants during pregnancy, more so than non psychiatric drugs, however, evidence based counseling can lower this fear, although not totally. Deciding whether to continue to take a medication or not during pregnancy, is a complex decision for women and their healthcare providers to make.

Adult↗

Pain management for neonatal circumcision.

Circumcision is the most common surgical procedure performed in the neonatal period in North America. If untreated, the pain of circumcision causes both short and long term changes in infant behaviours. The most widely studied pharmacological intervention for pain management during circumcision is dorsal penile nerve block (DPNB) by injected lidocaine (lignocaine). Randomised controlled trials have demonstrated its efficacy; infants premedicated with lidocaine have significantly smaller changes in physiological and pain-related behaviours compared with infants who are not given analgesics. A meta-analysis of injection-related adverse effects (bruising/haematoma) yielded a risk of 6.7% (95% confidence interval, 0.5 to 12.9%). Systemic toxicity from injected local anaesthesia has not been reported. Less effective modalities include topical anaesthesia with lidocaine-prilocaine cream [Eutectic Mixture of Local Anaesthetics (EMLA)], lidocaine cream and oral administration of sucrose. The good tolerability of lidocaine-prilocaine cream has been demonstrated by a lack of clinically significant methaemoglobinaemia when used appropriately. Nonpharmacological interventions (pacifier, specially designed restraint chair) reduce distress during the procedure, and paracetamol (acetaminophen) may provide postoperative analgesia. No single agent has been demonstrated to ameliorate pain for all infants undergoing circumcision. A multimodal approach of pharmacotherapy is currently recommended. Studies evaluating the efficacy of combined analgesia have demonstrated significant benefits for combinations of 2 or more forms of treatment (such as DPNB and sucrose-dipped pacifier) compared with single interventions. The instrument used to perform the circumcision is also important. The Mogen clamp has been shown to be associated with a shorter procedure time and less pain compared with the Gomco clamp. If circumcision is to be performed on infants, it is, therefore, recommended that combined analgesia and the Mogen clamp technique are used, and nonpharmacological stress reducing interventions such as pacifiers and comfortable restraining chairs should also be employed.

Acetaminophen↗

Combined analgesia and local anesthesia to minimize pain during circumcision.

BACKGROUND: Pain of circumcision is only partially relieved by single modalities, such as penile nerve block, lidocaine-prilocaine cream, and sucrose pacifiers. OBJECTIVE: To assess the effectiveness of a combination of interventions on the pain response of infants undergoing circumcision. METHODS: Cohort study. Group 1 included infants circumcised using the Mogen clamp and combined analgesics (lidocaine dorsal penile nerve block, lidocaine-prilocaine, acetaminophen, and sugar-coated gauze dipped in grape juice). Group 2 included infants circumcised using the Gomco clamp and lidocaine-prilocaine. Infants were videotaped during circumcision, and pain was assessed using facial activity scores and percentage of time spent crying. RESULTS: There were 57 infants in group 1 and 29 infants in group 2. Birth characteristics did not differ between groups. Infants in group 1 were older than infants in group 2 (17 days vs 2 days) (P < .001). The mean duration of the procedure was 55 seconds and 577 seconds for infants in group 1 and 2, respectively (P < .001). Facial action scores and percentage of time spent crying were significantly lower during circumcision for infants in group 1 (P < .001). The percentage of time spent crying was 18% and 40% for infants in groups 1 and 2, respectively. No adverse effects were observed in infants in group 1; 1 infant in group 2 had a local skin infection. CONCLUSIONS: Infants circumcised with the Mogen clamp and combined analgesia have substantially less pain than those circumcised with the Gomco clamp and lidocaine-prilocaine cream. Because of the immense pain during circumcision, combined local anesthesia and analgesia using the Mogen clamp should be considered.

Acetaminophen↗

Lidocaine-prilocaine cream for analgesia during circumcision in newborn boys.

BACKGROUND: Neonates routinely undergo tissue-damaging interventions as part of medical treatment. The skin is the site of noxious stimulation for many procedures, including circumcision. EMLA (eutectic mixture of local anesthetics) penetrates intact skin and has the potential to reduce pain associated with circumcision. OBJECTIVES: To determine the effectiveness of EMLA compared to placebo or no treatment as an analgesic for circumcision in male newborns. SEARCH STRATEGY: The guidelines of the Cochrane Neonatal Review Group were followed. No language restrictions were applied. Three reviewers (AT, KO, AO) agreed through a consensus process on the inclusion of a specific study. SELECTION CRITERIA: Randomized controlled trials assessing the efficacy/effectiveness of EMLA to prevent circumcision associated pain. Behavioral and physiological outcome data were accepted for efficacy/effectiveness. DATA COLLECTION AND ANALYSIS: Data abstracted from each report included gestational age at birth, timing and dosage regimen of EMLA, control group treatment and outcomes. Abstracted data were verified by the three investigators (AT, KO, AO). MAIN RESULTS: During the different stages of the surgical procedure for circumcision, the increase in heart rate was 12 - 27 beats per minute less for the EMLA group compared to placebo. In a single study, neonates treated with EMLA showed a higher oxygen saturation. Although the data from the three studies could not be combined, crying during circumcision was reported as less in the EMLA treated groups. In two studies, facial action was lower in the EMLA treated groups compared to placebo. REVIEWER'S CONCLUSIONS: EMLA reduces pain response during circumcision in newborn male infants. Other potentially more effective forms of analgesia for circumcision (such as dorsal penile nerve block, ring block) should be subjected to systematic reviews.

Anesthetics, Local↗

Intravenous midazolam infusion for sedation of infants in the neonatal intensive care unit.

BACKGROUND: The need for sedation for neonates undergoing uncomfortable procedures in the neonatal intensive care unit (NICU) has often been overlooked. Proper sedation may reduce stress and avoid complications during procedures such as mechanical ventilation. Midazolam is a short acting benzodiazepine that has been increasingly used in the NICU. However, the effectiveness of intravenous midazolam as a sedative in neonates has not been systematically evaluated. OBJECTIVES: To determine whether intravenous midazolam infusion is an effective sedative, as evaluated by behavioural and/or physiologic measurements, for critically ill neonates undergoing intensive care, and to assess clinically significant short and long term adverse effects associated with its use. SEARCH STRATEGY: Literature search according to the Cochrane Neonatal Collaborative Review Group search strategy. Randomized and quasi-randomized controlled trials of intravenous midazolam use in neonates were identified by searching MEDLINE, EMBASE, the Cochrane Controlled Trials Register, reference lists of published studies, personal files, and abstracts published in Pediatric Research from 1990-1999. SELECTION CRITERIA: Randomized controlled trials of intravenous midazolam infusion in infants </= 28 days of age for sedation during mechanical ventilation or radiologic investigations were selected for review. Studies on midazolam use as an anesthetic or an anticonvulsant were excluded. Studies involving neonates and older infants and children were excluded if data for neonates could not be extracted. DATA COLLECTION AND ANALYSIS: Data regarding the primary outcome of level of sedation (as evaluated by behavioural scales or physiologic parameters) were abstracted. Secondary outcomes including intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), death within 28 days of age, adverse effects associated with midazolam (hemodynamic and neurologic), days of ventilation, days of supplemental oxygen use, pneumothorax, length of NICU stay, and long term neurodevelopmental outcome were assessed. When appropriate, meta-analyses were performed using relative risk (RR), risk difference (RD), along with their 95% confidence intervals (95% CI) for categorical variables and weighted mean difference (WMD) for continuous variables. MAIN RESULTS: Two trials were eligible for inclusion in the review. Data on level of sedation from the two trials could not be combined because of differences in tools used to measure sedation levels. One study (Jacqz-Aigrain 1994) showed statistically a significant higher level of sedation in the midazolam group compared to the placebo group. The other study (Anand 1999) comparing midazolam to morphine and placebo found no statistically significant difference in sedation level among the three groups, but statistically significantly higher level of sedation was found in the midazolam group compared with the placebo group during the treatment infusion. However, since the sedation scales used in both studies have not been validated in preterm infants, the effectiveness of midazolam as a sedative in this population could not be ascertained based on the findings of these two studies. In the study by Jacqz-Aigrain (1994), blood pressures were statistically significantly lower in the midazolam group than in the placebo group on days 1 and 2, although there was no statistically significant difference in the incidence of hypotension requiring albumin or vasoactive drugs between groups. The study by Anand (1999) showed a statistically significant higher incidence of adverse neurologic events (death, grade III-IV IVH, PVL) in the midazolam group compared with the other groups. In addition, the midazolam group had a statistically significantly longer duration of NICU stay compared to the placebo group (WMD 5.4 days, 95%CI 0.4, 10.5). (ABSTRACT TRUNCATED)

Humans↗

Management of pain from heel lance with lidocaine-prilocaine (EMLA) cream: is it safe and efficacious in preterm infants?

Hospitalized preterm infants undergo multiple painful heel lances. A two-phase, randomized, controlled trial was undertaken to determine the safety and efficacy of lidocaine-prilocaine 5% cream (EMLA, Astra Pharmaceuticals, L.P, Westborough, MA) for relieving pain from heel lance. One hundred twenty infants were randomly assigned to receive 0.5 g of EMLA or placebo cream for 30 minutes (Phase 1) or 60 minutes (Phase 2) before a routine heel lance. Efficacy was assessed using the Premature Infant Pain Profile (PIPP). Safety was determined by methemoglobin concentration 8 hours after EMLA application and by clinical signs of methemoglobinemia. No significant differences existed on PIPP scores between EMLA and placebo groups in Phase 1 (p < .480) or Phase 2 (p < .831). No infant had any clinical signs of methemoglobinemia. The mean methemoglobin concentration was 1.19% (.47). Approximately 10% of infants had minor skin reactions, and approximately 20% of EMLA-treated infants had blanching at the application site. The authors conclude that EMLA is safe but not efficacious for relieving pain from heel lance in preterm infants.

Anesthetics, Combined↗

Relative efficacy of amethocaine gel and lidocaine-prilocaine cream for Port-a-Cath puncture in children.

BACKGROUND: Lidocaine-prilocaine cream (EMLA) is currently standard therapy to alleviate procedural pain in children. One of the disadvantages of lidocaine-prilocaine is the need to wait for 60 minutes for adequate skin anesthesia. Amethocaine gel (Ametop) is a new topical anesthetic that requires a shorter application time for skin anesthesia. OBJECTIVES: To compare the relative efficacy and safety of amethocaine gel and lidocaine-prilocaine cream in children with cancer undergoing Port-a-Cath puncture and to determine which patient factors influence judgments about pain. METHODS: Randomized, blinded, crossover study. Each child received either 1 g of amethocaine gel for 30 minutes, preceded by a placebo gel for 30 minutes, or 1 g of lidocaine-prilocaine cream for 60 minutes. Children rated the pain using the faces scale, for which scores ranged from 0 to 5. Parents and attending nurse operators rated pain on a 10-cm visual analog scale. RESULTS: Thirty-nine children participated. The mean age was 10.2 years (range: 5-16 years), and 69% were male. There were no differences in mean pain assessments between amethocaine and lidocaine-prilocaine as rated by the children (2.0 vs 0.5), parents (2.6 vs 6.4), or nurse operators (2.0 vs 0.9). No serious adverse effects were detected with either preparation. Pain scores assigned by parents and children were not influenced by age, gender, duration of diagnosis, or anesthetic regimen (amethocaine versus lidocaine-prilocaine) in the child. Nurses, however, rated pain higher for younger children, and in males during pretreatment with lidocaine-prilocaine. CONCLUSION: Amethocaine achieves similar anesthesia to lidocaine-prilocaine during Port-a-Cath administration in children, with an application time that is half of lidocaine-prilocaine. Pain assessments were not influenced by age, gender, or duration of diagnosis of the child. Nurses may perceive that pain is greater for younger children and in males. lidocaine-prilocaine, amethocaine, pain, children, Port-a-Cath puncture.

Adolescent↗

Pharmacokinetics of three doses of epidural ropivacaine during hysterectomy and comparison with bupivacaine.

PURPOSE: Ropivacaine is a new long-acting aminoamide local anaesthetic, structurally related to bupivacaine. The clinical efficacy of 125 mg, 187.5 mg and 250 mg ropivacaine have been reported and compared with 125 mg bupivacaine for epidural analgesia during hysterectomy. In the pharmacokinetic part of this study the objectives were to 1) determine the dose proportionality in the pharmacokinetics of epidural ropivacaine, and 2) compare the pharmacokinetics of 125 mg ropivacaine and 125 mg bupivacaine. METHODS: In a randomized, double-blind controlled study, patients received one of four treatment regimens with ropivacaine (125, 187.5 or 250 mg) or bupivacaine (125 mg) as a 25 ml epidural bolus administered over three minutes. Peripheral venous blood samples were collected over 24 hr for ropivacaine or bupivacaine quantification using gas chromatography with nitrogen sensitive detection. Pharmacokinetic variables were derived from plasma concentration-time curve data. RESULTS: Fifty two women entered the study. Demographic characteristics were similar among groups. Six patients were excluded due to inadequate sensory block or an insufficient number of plasma samples. The peak plasma concentration (Cmax) of ropivacaine and the total area under the plasma concentration-time curve (AUC) increased proportionally with the dose. Apparent plasma clearance (CL) and the terminal half-life (t1/2) were similar in the three ropivacaine groups. When compared with the 125 mg ropivacaine group, the bupivacaine group had a longer terminal half life (P < 0.05). CONCLUSIONS: Epidural ropivacaine displays dose-proportional pharmacokinetic behaviour for doses of 125 mg to 250 mg. Ropivacaine has a shorter terminal half-life than bupivacaine.

Adult↗

Randomised controlled trial of paracetamol for heel prick pain in neonates.

AIM: To evaluate the effectiveness of paracetamol in decreasing the pain from heel prick. METHODS: A prospective randomised double blind placebo controlled trial was conducted of 75 term neonates undergoing heel prick. Sixty to 90 minutes before the procedure neonates received paracetamol orally in a dose of 20 mg/kg (group 1) or an equal volume of placebo (group 2). Heel prick was performed in a standardised manner. Pain assessments were made using per cent facial action (brow bulge, eye squeeze, and nasolabial fold (range 0-300%) and per cent of time spent crying (range 0-100%). RESULTS: Thirty eight neonates were enrolled in group 1 and 37 neonates in group 2. There were no significant differences in the demographic characteristics between groups. Mean gestational age was 39 (SD 1.4) vs 39.4 (SD 1.2) weeks, p = 0.86, mean birthweight 3.45 (SD 0.45) vs 3.44 (SD 0.42) kg; p = 0.31 for groups 1 and 2, respectively. Facial action pain scores did not differ between groups (143.5 (SD 54.2)% vs 131.1 (SD 59.6)%; p = 0.38). Cry scores also did not differ (29.4 (SD 19.9)% vs 26.8 (SD 20.2)%; p = 0.60). No adverse effects were observed. CONCLUSION: Paracetamol is ineffective for decreasing the pain from heel prick in term neonates.

Acetaminophen↗

A systematic review of lidocaine-prilocaine cream (EMLA) in the treatment of acute pain in neonates.

OBJECTIVE: Neonates routinely undergo painful cutaneous procedures as part of their medical treatment. Lidocaine-prilocaine 5% cream (EMLA) is a topical anesthetic that may be useful for diminishing the pain from these procedures. EMLA is routinely used in children and adults. There is substantial apprehension about its use in neonates because of concerns that it may cause methemoglobinemia. The objective of this review was to determine the efficacy and safety of EMLA as an analgesic for procedural pain treatment in neonates and provide evidence-based recommendations for clinical practice. METHODS: Systematic review techniques were used. Studies were identified using manual and computer-aided searches (Medline, EMBASE, Reference Update, personal files, scientific meeting proceedings). Behavioral (eg, facial action, crying) and physiologic (eg, heart rate, oxygen saturation, blood pressure, respiratory rate) outcome data from prospective nonrandomized controlled studies and randomized controlled trials in full-term and preterm neonates were accepted for inclusion to establish efficacy of EMLA. The risk of methemoglobinemia (defined as methemoglobin concentration >5% and requiring medical intervention) was estimated from all prospective studies. RESULTS: Eleven studies of the efficacy of EMLA were included in the analysis. Infant gestational age at the time of delivery ranged from 26 weeks to full-term. Two studies included data from both neonates and older infants. The following procedures were studied: circumcision (n = 3), heel lancing (n = 4), venipuncture (n = 1), venipuncture and arterial puncture (n = 1), lumbar puncture (n = 1), and percutaneous venous catheter placement (n = 1). Nine studies were randomized controlled trials. The total sample size for each study ranged from 13 to 110 neonates. The dose of EMLA used was 0.5 g to 2 g in 9 studies, and was not specified in the others. The duration of application ranged from 10 minutes to 3 hours. The three studies that investigated the efficacy of EMLA for decreasing the pain of circumcision used a randomized controlled trial design. All of them demonstrated significantly reduced crying time during the procedure in the infants in the EMLA group compared with the infants in the control group. Facial grimacing, assessed in two of the studies, was also significantly lower in the EMLA group. Using meta-analytic techniques, the heart rate outcome data for two studies was summarized. Increases in heart rate compared with baseline values were 12 to 27 beats per minute less for the EMLA group than in the placebo group during various stages of the surgical procedure. Three studies that investigated the pain from heel lancing were randomized controlled trials; the other was a nonrandomized controlled study. None demonstrated a significant benefit of EMLA for any of the outcome measures used to assess pain (ie, behavioral pain scores, infant crying, heart rate, blood pressure, respiratory rate, oxygenation parameters). One randomized controlled study of the pain from venipuncture showed that infants treated with EMLA had significantly lower heart rates and cry duration compared with infants treated with a placebo. In one nonrandomized study, a significantly lower behavioral pain score was observed for infants treated with EMLA compared with the control group. Infant heart rate, however, did not differ between the groups. In one randomized controlled study of pain from percutaneous venous catheter placement, EMLA resulted in a significantly lower increase in heart rate and respiratory rate. Behavioral pain scores were significantly lower during arterial puncture in one nonrandomized controlled study. EMLA did not reduce physiologic changes or behavioral pain scores in one randomized controlled trial in infants undergoing lumbar puncture. Meta-analytic techniques revealed that methemoglobin concentrations did not differ between EMLA-treated and placebo-treated infants (weighted mean di

Acute Disease↗

Efficacy and safety of lidocaine-prilocaine cream for pain during circumcision.

BACKGROUND: Neonatal circumcision is a painful surgical procedure often performed without analgesia. We assessed the efficacy and safety of 5 percent lidocaine-prilocaine cream (Emla) in neonates undergoing circumcision. METHODS: We carried out a double-blind, randomized, controlled trial in 68 full-term male neonates: 38 were assigned to receive lidocaine-prilocaine cream, and 30 to receive placebo. One gram of lidocaine-prilocaine or placebo cream was applied to the penis under an occlusive dressing for 60 to 80 minutes before circumcision. Behavioral (facial activity and time spent crying) and physiologic (heart rate and blood pressure) responses were recorded during the procedure. Blood samples were obtained at various times after drug application for measurements of methemoglobin and plasma lidocaine, prilocaine, and o-toluidine (a metabolite of prilocaine). RESULTS: A total of 68 and 59 neonates were included in the safety and efficacy analyses, respectively. Demographic characteristics such as gestational age and birth weight did not differ between the lidocaine-prilocaine and placebo groups. During circumcision, the neonates in the lidocaine-prilocaine group had less facial activity (P= 0.01), spent less time crying (P<0.001), and had smaller increases in heart rate (P=0.007) than the neonates in the placebo group. Facial-activity scores were 12 to 49 percent lower during various steps of the procedure in the lidocaine-prilocaine group. As compared with neonates in the placebo group, infants in the lidocaine-prilocaine group cried less than half as much and had heart-rate increases of 10 beats per minute less. Blood methemoglobin concentrations (expressed as a percentage of the hemoglobin concentration) were similar (1.3 percent) in both groups. Lidocaine and prilocaine were detected in plasma in 23 (61 percent) and 21 (55 percent) of the infants treated with lidocaine-prilocaine cream, respectively. CONCLUSIONS: Lidocaine-prilocaine cream is efficacious and safe for the prevention of pain from circumcision in neonates.

Anesthesia, Local↗

Effect of neonatal circumcision on pain response during subsequent routine vaccination.

BACKGROUND: Preliminary studies suggested that pain experienced by infants in the neonatal period may have long-lasting effects on future infant behaviour. The objectives of this study were to find out whether neonatal circumcision altered pain response at 4-month or 6-month vaccination compared with the response in uncircumcised infants, and whether pretreatment of circumcision pain with lidocaine-prilocaine cream (Emla) affects the subsequent vaccination response. METHODS: We used a prospective cohort design to study 87 infants. The infants formed three groups--uncircumcised infants, and infants who had been randomly assigned Emla or placebo in a previous clinical trial to assess the efficacy of Emla cream as pretreatment for pain in neonatal circumcision. Infants were videotaped during vaccination done at the primary care physician's clinic. Videotapes were scored without knowledge of circumcision or treatment status by a research assistant who had been trained to measure infant facial action, cry duration, and visual analogue scale pain scores. FINDINGS: Birth characteristics and infant characteristics at the time of vaccination, including age and temperament scores, did not differ significantly among groups. Multivariate ANOVA revealed a significant group effect (p < 0.001) in difference (vaccination minus baseline) values for percentage facial action, percentage cry time, and visual analogue scale pain scores. Univariate ANOVAs were significant for all outcome measures (p < 0.05): infants circumcised with placebo had higher difference scores than uncircumcised infants for percentage facial action (136.9 vs 77.5%), percentage cry duration (53.8 vs 24.7%), and visual analogue scale pain scores (5.1 vs 3.1 cm). There was a significant linear trend on all outcome measures, showing increasing pain scores from uncircumcised infants, to those circumcised with Emla, to those circumcised with placebo. INTERPRETATION: Circumcised infants showed a stronger pain response to subsequent routine vaccination than uncircumcised infants. Among the circumcised group, preoperative treatment with Emla attenuated the pain response to vaccination. We recommend treatment to prevent neonatal circumcision pain.

Analysis of Variance↗

The efficacy of sucrose for relieving procedural pain in neonates--a systematic review and meta-analysis.

The objective was to determine the efficacy and optimal dose of sucrose for relieving procedural pain in neonates. Data were obtained using MEDLINE, EMBASE, Reference Update and personal files and assessed for quality of the methods. Data from all randomized controlled trials where term and preterm neonates received a heelstick or venipuncture were examined for the efficacy of different sucrose doses (0.18 g, 0.24 g, 0.48 g or 0.50 g, 1.0 g) and water (placebo). The primary outcome was the proportion of time crying during 3 min after the painful stimulus. Data were combined across studies using a random effects model, adapted for use with single groups, producing a point estimate and 95% confidence interval (CI). Thirteen trials were identified; eight were rejected as data were inappropriate, non-extractable, or the primary outcome was not measured. Five studies provided data on 271 infants. The proportion of time crying did not differ between 0.18 g of sucrose and water (p > 0.05) but was significantly lower in all other sucrose groups. There were no differences in proportion of time crying between term and preterm neonates. Sucrose reduced the proportion of time crying during painful procedures in neonates. The 0.18 g dose of sucrose was ineffective. Doses of 0.24 g (2 ml of 12% sucrose solution) were most effective. A dose of 0.50 g provided no additional benefit.

Analgesics↗

Neonatal pain response to heel stick vs venepuncture for routine blood sampling.

Neonatal pain response and adverse effects and maternal anxiety were assessed in 27 infants who were randomly allocated to venepuncture or heel stick. Pain was assessed by nurses using the Neonatal Infant Pain Scale (NIPS) and a three point scale for the mothers. NIPS scores were higher in the heel stick group compared with the venepuncture group. Maternal anxiety was higher before the procedure while perception of an infant's pain was lower in the venepuncture group compared with the heel stick group. Venepuncture is less painful than heel stick in newborn infants undergoing routine blood sampling.

Anxiety↗

Excretion of fluoxetine and its metabolite, norfluoxetine, in human breast milk.

A study was conducted to measure breast milk concentrations of fluoxetine and its active metabolite, norfluoxetine, excreted in breast milk in a cohort of nursing women using fluoxetine, and to estimate infant dose from nursing. The study included 10 women nursing 11 infants (median age, 185 days). The mean fluoxetine dose was 0.39 mg/kg/day. Each patient manually collected 3 to 6 milk samples throughout a dosing interval. Concentrations of fluoxetine and norfluoxetine in milk were measured by gas-liquid chromatography. Mothers reported whether they observed adverse effects in their infants. The average infant doses of fluoxetine and norfluoxetine, as estimated for an exclusively breast-fed infant ingesting 1000 mL of milk per day, were 0.077 mg (SD = 0.054 mg) and 0.084 mg (SD = 0.043 mg), respectively. The total dose of fluoxetine and norfluoxetine (expressed as fluoxetine equivalents) was 0.165 mg (SD = 0.092 mg), which was equivalent to 10.8% (SD = 2.2%) of the maternal dose, adjusted on a mg/kg basis in a 4-kg infant. No adverse events were reported by mothers in their infants. Approximately one tenth of the adult therapeutic dose of fluoxetine is excreted in breast milk. Although short-term adverse effects in the infant from exposure through nursing were not reported in this cohort, future studies that assess the potential long-term consequences are needed.

Adult↗

Premature Infant Pain Profile: development and initial validation.

OBJECTIVE: Inadequate assessment of pain in premature infants is a persistent clinical problem. The objective of this research was to develop and validate a measure for assessing pain in premature infants that could be used by both clinicians and researchers. DESIGN: The Premature Infant Pain Profile (PIPP) was developed and validated using a prospective and retrospective design. Indicators of pain were identified from clinical experts and the literature. Indicators were retrospectively tested using four existing data sets. PATIENTS AND SETTINGS: Infants of varying gestational ages undergoing different painful procedures from three different settings were utilized to develop and validate the measure. METHODS AND RESULTS: The largest data set (n = 124) was used to develop the PIPP. The development process included determining the factor structure of the data, developing indicators and indicator scales and establishing internal consistency. The remaining three data sets were utilized to establish beginning construct validity. CONCLUSIONS: The PIPP is a newly developed pain assessment measure for premature infants with beginning content and construct validity. The practicality and feasibility for using the PIPP in clinical practice will be determined in prospective research in the clinical setting.

Gestational Age↗

Effect of neonatal circumcision on pain responses during vaccination in boys.

Using data from one of our randomised trials, we investigated post-hoc whether male neonatal circumcision is associated with a greater pain response to routine vaccination at 4 or 6 months. Pain response during routine vaccination with diphtheria-pertussis-tetanus (DPT) alone or DPT followed by Haemophilus influenzae type b conjugate (HIB) was scored blind. 42 boys received DPT and 18 also received HIB. After DPT, median visual analogue scores by an observer were higher in the circumcised group (40 vs 26 mm, p = 0.03). After HIB, circumcised infants had higher behavioural pain scores (8 vs 6, p = 0.01) and cried longer (53 vs 19 s, p = 0.02). Thus neonatal circumcision may affect pain response several months after the event.

Circumcision, Male↗