Carol McNair

A randomized controlled trial evaluating the efficacy of tetracaine gel for pain relief from peripherally inserted central catheters in infants.

BACKGROUNDInsertion of peripherally inserted central catheters (PICC) is a commonly performed procedure in both preterm and term infants. Tetracaine 4% gel (Ametop; Smith & Nephew Inc, St. Laurent, Quebec), a topical anesthetic, although reported to be effective for reducing the pain of venipuncture in neonates, has not been investigated for the management of pain associated with the PICC procedure. PURPOSETo determine the efficacy of tetracaine gel for managing the pain associated with the PICC procedure in preterm and term infants. METHODSA double-blind, placebo-controlled, randomized controlled trial (RCT) design was used. Infants undergoing nonurgent PICC insertion were randomized to receive either the treatment (1.0 g of tetracaine 4% gel) or placebo control (1.0 g of eucerin-plus cream) applied to the skin under occlusion for 30 minutes before the procedure. Data on the behavioral (facial expression) and physiologic (heart rate and oxygen saturation) indicators of pain were collected via videotaping and computer monitoring throughout the procedure. Data then were coded and measured by independent observers using the Premature Infant Pain Profile (PIPP; Stevens et al, 1996), and analyzed using descriptive statistics and repeated-measures analyses of variance. RESULTSForty-nine infants, gestational age 27 to 41 weeks (mean = 33; SD = 4.2) and age at time of insertion 2 to 85 days (mean = 18; SD = 22.5) participated. No differences were found between the groups at the time of randomization. There were no adverse cardiorespiratory events or local skin reactions in either group. There was a significant within-subjects main effect of time across the procedure (F[48,3] = 11.03; P < 0.0001). There was no significant between-subjects main effect of group (F[48,1] = 0.11; P = 0.74) and no (group × time) interaction (F[48,3] = 0.45; P = 0.72). CONCLUSIONTetracaine gel was not effective for pain relief for PICC insertion in infants. Its use for pain relief cannot be recommended based on the results of this study. Other pharmacologic, behavioral, and physical interventions should be investigated for safety and relief of procedural pain in this population of infants.

Variability in clinical practice guidelines for sweetening agents in newborn infants undergoing painful procedures

ObjectiveSweetening agents have been recommended in position statements and consensus documents for procedural pain management in neonates; however, it is not clear if this has resulted in widespread adoption in clinical practice. The objective of this study was to investigate unit-specific protocols for the use of sweetening agents. MethodsStructured telephone survey with qualified personnel in special care (level II) nurseries and neonatal intensive care (level III) units across Canada. The frequency and pattern of recommended use of sweetening agents was documented. ResultsEighty-six of 92 units (93.5%) participated. Sixty-four percent recommended sucrose and 2.3% recommended glucose for procedural pain management; 87.7% had a guideline. Sweetening agents were most commonly recommended for venipuncture/venous cannulation (91.2% for both), lumbar puncture (87.7%), and heel lance (82.5%). Dosing guidelines ranged from 0.05u2009mL of 24% sucrose solution to 3u2009mL of 25% sucrose solution. Sweeteners were not recommended for infants with necrotizing enterocolitis (77.2%) or those who were nil per os (75%). ConclusionsSweetening agents were recommended for procedural pain management in two-thirds of special care nurseries and neonatal intensive care units across Canada with extensive variability in specific dosing guidelines. Audits of pain management practices should therefore account for unit-specific practice guidelines.

Nonpharmacological Management of Pain During Common Needle Puncture Procedures in Infants. Current Research Evidence and Practical Considerations

All infants undergo painful procedures involving skin puncture as part of routine medical care. Pain from needle puncture procedures is suboptimally managed. Numerous nonpharmacologic interventions are available for these painful procedures, including swaddling, holding, skin-to-skin care, pacifier, sweet-tasting solutions, and breast-feeding. Adoption of nonpharmacologic pain-relieving interventions into routine clinical practice is feasible and should be a standard of care in the delivery of quality health care for infants. This review summarizes current knowledge about the epidemiology of pain from common needle puncture procedures in infants, the effectiveness of nonpharmacologic interventions, implementation considerations, and unanswered questions for future research.

A randomized trial of rotavirus vaccine versus sucrose solution for vaccine injection pain.

OBJECTIVEnSucrose 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.nnnMETHODSnInfants 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.nnnRESULTSnAltogether, 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.nnnCONCLUSIONnRotavirus 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.

Canadian neonatologist practices regarding opioid use in ventilated and spontaneously breathing infants undergoing medical procedures.

ObjectivesOpioids are indicated for the management of procedural pain in neonates. There are limited data describing factors influencing patterns of use. Patients and MethodsWe conducted an online English survey of Canadian neonatologists using Survey Monkey, whereby they answered questions about the frequency and pattern of use of opioids, and specifically, of morphine and fentanyl, for ventilated and spontaneously breathing infants undergoing selected painful medical procedures. ResultsHundred and twenty nine of 225 (57%) eligible neonatologists participated. They reported that opioids were part of their practice for managing procedural pain in 100% of ventilated infants and 93% of spontaneously breathing infants. Frequency of opioid use was associated with infant ventilation status: spontaneously breathing infants were 28% less likely to receive them (P=0.013). For morphine, the most commonly used dose was 100u2009μg/kg in ventilated infants and 50u2009μg/kg in spontaneously breathing infants. For fentanyl, 1u2009μg/kg was the most frequently used dose in both infant populations. Use of morphine and fentanyl were significantly associated with 2-way interactions (P<0.0001) between infant ventilation status, gestational age, and opioid dose. Eighty-two percent of respondents cited respiratory depression as a concern for spontaneously breathing infants compared with 31% for ventilated infants (P<0.0001). ConclusionsNeonatologists frequently report using opioids to manage procedural pain, however, spontaneously breathing infants are less likely to receive them, and their use varies according to infant and procedure characteristics. These data point to the need to further investigate, in a more controlled design, the pharmacologic effects of opioids in this population to better guide clinicians about their optimal use.

Arrhythmia Associated With Tetracaine in an Extremely Low Birth Weight Premature Infant

Infants in NICUs undergo a variety of painful procedures. The management of pain has become an integral part of newborn infant care with the use of both systemic and topical agents to provide analgesia and anesthesia for procedural pain. Tetracaine and prilocaine-lidocaine are the 2 topical anesthetics most frequently used. Tetracaine belongs to an ester group of local anesthetics available as a topical 4% gel (Ametop, Smith and Nephew, Canada). The major side effects reported when using topical anesthetics are cutaneous reactions. There are no definite reports of systemic toxicity in the published literature. We present a recent case of an extremely low birth weight premature infant who developed a clinically significant arrhythmia after topical tetracaine was applied before the insertion of a peripherally inserted central catheter. The infant had no other identifiable cause for the resulting bradycardia that occurred only after Ametop was applied. The cardiac symptoms resolved with treatment. This case highlights a significant potential adverse event when using topical tetracaine.

The minimally effective dose of sucrose for procedural pain relief in neonates: a randomized controlled trial

BackgroundOrally administered sucrose is effective and safe in reducing pain intensity during single, tissue-damaging procedures in neonates, and is commonly recommended in neonatal pain guidelines. However, there is wide variability in sucrose doses examined in research, and more than a 20-fold variation across neonatal care settings. The aim of this study was to determine the minimally effective dose of 24% sucrose for reducing pain in hospitalized neonates undergoing a single skin-breaking heel lance procedure.MethodsA total of 245 neonates from 4 Canadian tertiary neonatal intensive care units (NICUs), born between 24 and 42xa0weeks gestational age (GA), were prospectively randomized to receive one of three doses of 24% sucrose, plus non-nutritive sucking/pacifier, 2 min before a routine heel lance: 0.1xa0ml (Group 1; nu2009=u200981), 0.5xa0ml (Group 2; nu2009=u200981), or 1.0xa0ml (Group 3; nu2009=u200983). The primary outcome was pain intensity measured at 30 and 60xa0s following the heel lance, using the Premature Infant Pain Profile-Revised (PIPP-R). The secondary outcome was the incidence of adverse events. Analysis of covariance models, adjusting for GA and study site examined between group differences in pain intensity across intervention groups.ResultsThere was no difference in mean pain intensity PIPP-R scores between treatment groups at 30xa0s (Pu2009=u2009.97) and 60xa0s (Pu2009=u2009.93); however, pain was not fully eliminated during the heel lance procedure. There were 5 reported adverse events among 5/245 (2.0%) neonates, with no significant differences in the proportion of events by sucrose dose (Pu2009=u2009.62). All events resolved spontaneously without medical intervention.ConclusionsThe minimally effective dose of 24% sucrose required to treat pain associated with a single heel lance in neonates was 0.1xa0ml. Further evaluation regarding the sustained effectiveness of this dose in reducing pain intensity in neonates for repeated painful procedures is warranted.Trial registrationClinicalTrials.gov: NCT02134873. Date: May 5, 2014 (retrospectively registered).

A cohort study of intranasal fentanyl for procedural pain management in neonates

ObjectivesnThe objective of this cohort study was to document experience with intranasal (IN) fentanyl analgesia for procedural pain management in neonates in a surgical neonatal intensive care unit. A consecutive sample of 23 neonates without intravenous access treated with IN fentanyl was included.nnnMethodsnData were extracted from medical charts, including infant characteristics, indication for IN fentanyl, dose, physiologic parameters (heart rate, respiratory rate, oxygen saturation, blood pressure) and pain scores. Physiologic parameters were recorded for 6 hours before and after IN fentanyl. Pain scores were recorded during and after the procedure using the Premature Infant Pain Profile (PIPP).nnnResultsnThe mean (SD) postmenstrual age of included infants was 31.8 weeks (4.1), and 52% were receiving some form of ventilator support. The mean dose of IN fentanyl was 1.3 mcg/kg (0.4) and most common indication was analgesia for peripheral insertion of central catheter. There were six cases of cardiorespiratory depression as defined, however, clinical factors could account for all of them. The mean PIPP score during and after the procedure was 4.3 (1.8) and 3.6 (1.5), respectively (scores <6 indicate no pain).nnnConclusionsnThis small study provides some preliminary evidence of the benefits and risks of IN fentanyl in this population.

Safety of fentanyl for peripherally inserted central catheter in non-intubated infants in the neonatal intensive care unit

ObjectiveTo evaluate the safety of fentanyl in non-intubated infants undergoing peripherally inserted central catheter (PICC) placement.MethodsA retrospective chart review of PICC placements over a 3 years’ period. We compared the 12h periods before and after fentanyl for clinically significant cardiorespiratory events (spells).ResultsOf the 998 neonates screened, 258 were eligible. The mean standard deviation gestational age was 34.1 (4.3) weeks and the median (inter-quartile range) postnatal age was 4 (7, 11) days. The mean (standard deviation) fentanyl dose was 0.6 (0.2) µg/kg. Respiratory depression occurred only in two infants (prevalence rateu2009=u20090.78%, 95% CI (0, 1.85)). No cases of hypotension or chest wall rigidity occurred. There was no evidence of an increase in the number of infants with spells or in the number of spells per infant (pu2009=u20090.34 and pu2009=u20090.06, respectively).ConclusionFentanyl appears to be associated with only a small risk of respiratory depression in non-intubated infants.