Removing barriers to accessing medical cannabis for paediatric patients.

Medical cannabis (MC) may offer therapeutic benefits for children with complex neurological conditions and chronic diseases. In Canada, parents, and caregivers frequently report encountering barriers when accessing MC for their children. These include negative preconceived notions about risks and benefits, challenges connecting with a knowledgeable healthcare provider (HCP), the high cost of MC products, and navigating MC product shortages. In this manuscript, we explore several of these barriers and provide recommendations to decision-makers to enable a family-centered and evidence-based approach to MC medicine and research for children.

Calmer: a robot for managing acute pain effectively in preterm infants in the neonatal intensive care unit.

INTRODUCTION: For preterm infants in the neonatal intensive care unit, early exposure to repeated procedural pain is associated with negative effects on the brain. Skin-to-skin contact with parents has pain-mitigating properties, but parents may not always be available during procedures. Calmer, a robotic device that simulates key pain-reducing components of skin-to-skin contact, including heart beat sounds, breathing motion, and touch, was developed to augment clinical pain management. OBJECTIVE: Our objective was to evaluate the initial efficacy of Calmer for mitigating pain in preterm infants. We hypothesized that, compared to babies who received a human touch-based treatment, facilitated tucking, infants on Calmer would have lower behavioural and physiological pain indices during a single blood test required for clinical care. METHODS: Forty-nine preterm infants, born between 27 and 36 weeks of gestational age, were randomized either to facilitated tucking or Calmer treatment. Differences between groups in changes across 4 procedure phases (baseline 1, baseline 2, poke, and recovery) were evaluated using (1) the Behavioral Indicators of Infant Pain scored by blind coders from bedside videotape and (2) heart rate and heart rate variability continuously recorded from a single-lead surface ECG (lead II) (Biopac, Canada) sampled at 1000 Hz using a specially adapted portable computer system and processed using Mindware. RESULTS: No significant differences were found between groups on any outcome measures. CONCLUSION: Calmer provided similar treatment efficacy to a human touch-based treatment. More research is needed to determine effects of Calmer for stress reduction in preterm infants in the neonatal intensive care unit over longer periods.

Evaluating pain in cerebral palsy: comparing assessment tools using the International Classification of Functioning, Disability and Health.

Purpose: Pain is prevalent and affects functioning and quality of life of children with cerebral palsy (CP). However, pain in CP is under recognized. The International Classification of Functioning, Disabiity and Health (ICF) guides the selection of comprehensive chronic pain assessment tools. Our objectives were to identify measures addressing pain in children with CP, characterize the content of each measure using the ICF, and identify gaps and overlaps. Materials and methods: Measures were identified from: (1) a systematic review of outcome measures (1998-2012) and (2) a scan of chronic pain measures (2013-2015). Included measures were those published in English, used in children and youth with CP, and contained an item/domain addressing pain. Constructs of the measures were linked to the ICF. Results: Overall, 31 measures addressing chronic pain in CP were included. Considerable variability was found in the degree to which their content represented the ICF. Most of pain measures address pain intensity and pain location (body functions) as opposed to functional impact of pain (activities and participation). Conclusions: Functional dimensions are poorly represented in pain measures. Our findings may guide the selection of measures for research and clinical needs for comprehensive chronic pain management in children with CP. Implications for Rehabilitation Chronic pain is prevalent among children with cerebral palsy and significantly interfere with functional activities. To effectively manage chronic pain in children with cerebral palsy, measures capturing functional-based information need to be part of routine chronic pain assessment.

Pediatric analgesic clinical trial designs, measures, and extrapolation: report of an FDA scientific workshop.

Analgesic trials pose unique scientific, ethical, and practical challenges in pediatrics. Participants in a scientific workshop sponsored by the US Food and Drug Administration developed consensus on aspects of pediatric analgesic clinical trial design. The standard parallel-placebo analgesic trial design commonly used for adults has ethical and practical difficulties in pediatrics, due to the likelihood of subjects experiencing pain for extended periods of time. Immediate-rescue designs using opioid-sparing, rather than pain scores, as a primary outcome measure have been successfully used in pediatric analgesic efficacy trials. These designs maintain some of the scientific benefits of blinding, with some ethical and practical advantages over traditional designs. Preferred outcome measures were recommended for each age group. Acute pain trials are feasible for children undergoing surgery. Pharmacodynamic responses to opioids, local anesthetics, acetaminophen, and nonsteroidal antiinflammatory drugs appear substantially mature by age 2 years. There is currently no clear evidence for analgesic efficacy of acetaminophen or nonsteroidal antiinflammatory drugs in neonates or infants younger than 3 months of age. Small sample designs, including cross-over trials and N of 1 trials, for particular pediatric chronic pain conditions and for studies of pain and irritability in pediatric palliative care should be considered. Pediatric analgesic trials can be improved by using innovative study designs and outcome measures specific for children. Multicenter consortia will help to facilitate adequately powered pediatric analgesic trials.

Does breastfeeding reduce acute procedural pain in preterm infants in the neonatal intensive care unit? A randomized clinical trial.

Managing acute procedural pain effectively in preterm infants in the neonatal intensive care unit remains a significant problem. The objectives of this study were to evaluate the efficacy of breastfeeding for reducing pain and to determine if breastfeeding skills were altered after this treatment. Fifty-seven infants born at 30-36 weeks gestational age were randomized to be breastfed (BF) or to be given a soother during blood collection. Changes in the Behavioral Indicators of Infant Pain (BIIP) and in mean heart rate (HR) across 3 phases of blood collection were measured. In the BF group, the Premature Infant Breastfeeding Behaviors (PIBBS) scale was scored before and 24 hours after blood collection. Longitudinal regression analysis was used to compare changes in Lance/squeeze and Recovery phases of blood collection between groups, with gestational age at birth, baseline BIIP scores, and mean HR included as covariates. Differences in PIBBS scores were assessed using a paired t-test. Relationships between PIBBS scores, BIIP scores, and HR were evaluated with Pearson correlations. No differences between treatment groups were found: BIIP (P=0.44, confidence interval [CI] -1.60-0.69); HR (P=0.73, CI -7.0-10.0). Infants in the BF group showed improved PIBBS scores after the treatment (P<0.01, CI -2.7 to -0.2). Lower BIIP scores during the Lance/squeeze were associated significantly with more mature sucking patterns (r=-0.39, P<0.05). Breastfeeding during blood collection did not reduce pain indices or interfere with the acquisition of breastfeeding skills. Exploratory analyses indicate there may be benefit for infants with mature breastfeeding abilities.

Biobehavioural reactivity to pain in preterm infants: a marker of neuromotor development.

In this preliminary study, it was examined whether capacity to react to external stress (acute pain) during neonatal intensive care predicts later neuromotor development at 4 and 8 months corrected chronological age (CCA) in high-risk preterm infants. Behavioural and cardiac reactivity to blood collection at 32 weeks postconceptional age (PCA) were recorded in addition to developmental outcomes at 4 and 8 months CCA in 35 preterm infants (17 males, 18 females) born