Toward integrated pediatric medicine: Key learnings from the pediatric integrative medicine trial.

OBJECTIVE: The purpose of this study is to explore the facilitators to integrating complementary therapies in conventional pediatric hospital practice based on the experiences of parents, healthcare providers, and complementary therapy providers. DESIGN: This study is part of a larger research study that examined the introduction of a pediatric integrative medicine service in an acute care children's hospital in Canada. A qualitative descriptive study was conducted using semi-structured one-on-one telephone and in-person interviews with a sample of parents of children, as well as healthcare providers and complementary therapy providers. RESULTS: A total of 50 individuals, from key-stakeholder groups, were interviewed between May 2014 and January 2016. This study identified the following facilitators for the integration of complementary therapies within conventional care: 1) stakeholders' open-mindedness and familiarity with care practices outside of their experiences; 2) stakeholders' open communication, respect for eachothers' roles in the process of care, and appreciation for the role of complementary therapies within conventional medicine; and 3) stakeholders' receptiveness to redefining the meaning of a 'positive outcome' in the context of hospital care. CONCLUSION: The findings of this study demonstrate that some of the existing barriers to the integration of complementary therapies in conventional hospital care could be mediated by creating an environment where the fundamental value of commitment to patient wellbeing is equally shared by all stakeholders.

Comparative Effectiveness of Pediatric Integrative Medicine: A Pragmatic Cluster-Controlled Trial.

Symptoms of pain, nausea/vomiting, and anxiety (PNVA) are highly prevalent in pediatric inpatients. Poorly managed symptoms can lead to decreased compliance with care, and prolonged recovery times. Pharmacotherapy used to manage PNVA symptoms is of variable effectiveness and carries safety risks. Complementary therapies to manage these symptoms are gaining popularity due to their perceived benefits and low risk of harm. Pediatric integrative medicine (PIM) is the combination of complementary therapies with conventional medicine in pediatric populations. A two-arm, cluster-controlled, pragmatic clinical trial was carried out to compare the effectiveness of a PIM service in conjunction with usual care, versus usual care only to treat PNVA symptoms in hospitalized pediatric patients. The primary outcome was the improvement of PNVA symptom severity using a 10-point numerical rating scale. Participant enrollment occurred between January 2013 and January 2016. A total of 872 participants (usual care n = 497; PIM n = 375) were enrolled. The PIM therapies significantly reduced PNVA symptom severity (p < 0.001). This study found that a hospital-based PIM service is both safe and effective for alleviating PNVA symptoms. Future research should carry out this work in other pediatric inpatient divisions, and in other sites to determine the reproducibility of findings.

Massage therapy for paediatric procedural pain: A rapid review.

BACKGROUND: Pain is a common paediatric problem, and procedural pain, in particular, can be difficult to manage. Complementary therapies are often sought for pain management, including massage therapy (MT). We assessed the evidence for use of MT for acute procedural pain management in children. METHODS: We searched five main databases for (i) primary studies in English, (ii) included children 0 to 18 years of age, (iii) compared MT for procedural pain management to standard care alone or placebo, and (iv) measured pain as the primary or secondary outcome. The data were extracted by one author and verified by a second author. Randomized controlled trials were evaluated using the Cochrane Risk of Bias tool. RESULTS: Eleven paediatric trials of procedural pain in neonatal, burn, and oncology populations, a total of 771 participants, were identified. Eight reported statistically significant reductions in pain after MT compared to standard care. Pain was measured using validated pain scales, or physiologic indicators. The studies were heterogeneous in population, techniques, and outcome measures used. No adverse events associated with MT were identified. CONCLUSION: MT may be an effective nonpharmacologic adjunct for management of procedural pain in children.

A caregiver, an expert, a patient: How complementary therapies support the roles of parents of children with life threatening conditions in hospital settings.

OBJECTIVE: The purpose of this study was to understand emerging roles of parents of hospitalized children with life threatening conditions and to explore how complementary therapies integrated into conventional pediatric care may shift and/or support these roles. DESIGN: This study is part of a larger research study that examined the introduction of a pediatric integrative medicine service at an acute care children's hospital in Canada. A qualitative descriptive study was conducted using one-on-one telephone interviews with a sample of parents of children included in the larger study. Children had access to complementary therapies including Reiki, massage therapy, and acupuncture. RESULTS: A total of 36 interviews were conducted between May 2014 and January 2016. This study found that parents of hospitalized children assume complex roles including that of caregiver, expert and patient (due to high levels of stress and anxiety). Moreover, the study reveals that the integration of complementary therapies with conventional care supports these parental roles. CONCLUSION: This study reveals that complementary therapies, introduced as a part of integrated approach to pediatric hospital care, and aimed primarily at managing distressing symptoms in patients, had simultaneously a positive contribution in providing parents with the means to navigate the complexities of parenting in the pediatric oncology and cardiology hospital wards and addressing some of their own needs.

Adverse events associated with paediatric massage therapy: a systematic review.

INTRODUCTION: Massage therapy (MT) is frequently used in children. No study has systematically assessed its safety in children and adolescents. We systematically review adverse events (AEs) associated with paediatric MT. METHODS: We searched seven electronic databases from inception to December 2018. We included studies if they (1) were primary studies published in a peer-reviewed journal, (2) involved children aged 0-18 years and (3) a type of MT was used for any indication. No restriction was applied to language, year of publication and study design. AEs were classified based on their severity and association to the intervention. RESULTS: Literature searches identified 12 286 citations, of which 938 citations were retrieved for full-text evaluation and 60 studies were included. In the included studies, 31 (51.6%) did not report any information on AEs, 13 (21.6%) reported that no AE occurred and 16 studies (26.6%) reported at least one AE after MT. There were 20 mild events (grade 1) that resolved with minimal intervention, 26 moderate events (grades 2-3) that required medical intervention, and 18 cases of severe AEs (grades 4-5) that resulted in hospital admission or prolongation of hospital stay; of these, 17 AEs were volvulus in premature infants, four of which were ultimately fatal events. CONCLUSION: We identified a range of AEs associated with MT use, from mild to severe. Unfortunately, the majority of included studies did not report if an AE occurred or not, leading to publication bias. This review reports an association between abdominal massage with volvulus without malrotation in preterm infants; it is still to be defined if this is casual or not, but our findings warrant caution in the use of abdominal massage in preterm infants.

Parents' experiences of an inpatient pediatric integrative medicine service for symptom management.

BACKGROUND: Pediatric integrative medicine (PIM) refers to the combination of treatments from conventional medicine and complementary therapies for which there is evidence of safety and effectiveness. As pediatric use of complementary therapies increases, it is important to determine parental views on the use of these therapies by their children. OBJECTIVE: To describe parental experiences with a PIM service for management of pain, nausea/vomiting and anxiety in the context of an inpatient pediatric cardiology unit. DESIGN: Telephone interviews were carried out with the parents of pediatric cardiology inpatients. The interviews focused on their and their child's experiences with the PIM service while in the hospital. Interviews were transcribed, and analyzed using qualitative content analysis. RESULTS: Data saturation was reached after nine interviews conducted during the period between June 2015 and January 2016. Parents self-reported that the PIM service was particularly helpful at alleviating symptoms of anxiety in their children. Moreover, because their children were more at ease, parents also felt less anxiety. CONCLUSION: Pediatric integrative medicine as an adjunct to conventional care is seen as beneficial by parents of children admitted to a pediatric cardiology unit.

Efficacy of music on sedation, analgesia and delirium in critically ill patients. A systematic review of randomized controlled trials.

PURPOSE: To systematically synthesize randomized controlled trial data on the efficacy of music to provide sedation and analgesia, and reduce incidence of delirium, in critically ill patients. MATERIAL AND METHODS: Relevant databases (Medline, PubMed, Embase, CINAHL, Cochrane, Alt Healthwatch, LILACS, PsycINFO, CAIRSS, RILM) were searched from inception to April 26, 2018. We also searched the reference lists of included publications and for ongoing trials. The selection of relevant articles was conducted by two researchers at two levels of screening. Data collection followed the recommendations from the Cochrane Systematic Reviews Handbook. We used the Cochrane Collaboration's tool for assessing risk of bias. Quality of the evidence was rated according to GRADE. RESULTS: The review identified six adult studies and no neonatal or pediatric studies. A descriptive analysis of study results was performed. Meta-analysis was not feasible due to heterogeneity. One study reported a reduction in sedation requirements with the use of music while the other five did not find any significant differences across groups. CONCLUSIONS: This systematic review revealed limited evidence to support or refute the use of music to reduce sedation/analgesia requirements, or to reduce delirium in critically ill adults, and no evidence in pediatric and neonatal critically ill patients.

Surveys of parents and clinicians concerning the minimally important difference of probiotic therapy for prevention of paediatric antibiotic-associated diarrhoea.

OBJECTIVES: To establish the minimally important difference (MID) that would prompt parents and clinicians to use probiotics for prevention of paediatric antibiotic-associated diarrhoea (AAD) and to obtain parent and clinician opinion about the most important outcomes in clinical trials of AAD. METHODS: In this survey, parents of children presenting to the emergency department of a Canadian tertiary care children's hospital and paediatricians working in that hospital were approached. A range of potential MIDs were presented and participants selected one that they would require to use probiotics for AAD prevention. In addition, participants were asked to rate a list of outcomes they would consider to be important in clinical trials of AAD. RESULTS: In total, 127 parents and 45 paediatricians participated. About 51% (64/125) of parents and 51% (21/41) of clinicians responding to the MID question reported they would use probiotics if it reduced the risk of AAD by 39% (ie, reduce the risk of AAD from 19% to 12%). The most important outcomes to parents, in descending order, were need for hospitalisation, prevention of dehydration, disruption of normal daily activities, diarrhoea duration and physician revisit. Paediatricians considered need for hospitalisation along with physician revisit as the most important outcomes. They rated prevention of dehydration, diarrhoea duration and stool frequency as important outcomes as well. CONCLUSION: There is good agreement between parents and clinicians regarding how effective probiotics would need to be in preventing AAD in order to warrant use. This information, along with outcomes perceived to be most important, will help in the design of future clinical trials.

Comparative effectiveness of pediatric integrative medicine as an adjunct to usual care for pediatric inpatients of a North American tertiary care centre: A study protocol for a pragmatic cluster controlled trial.

BACKGROUND: Some pediatric tertiary care centres in North America supplement conventional care with complementary therapies, together known as pediatric integrative medicine (PIM). Evidence to support the safety and efficacy of PIM is emerging, but the cost-effectiveness of an inpatient PIM service has yet to be assessed. METHODS/DESIGN: This study is a pragmatic cluster controlled clinical trial. Usual care will be compared to usual care augmented with PIM in three pediatric divisions; oncology, general medicine, and cardiology at one large urban tertiary care Canadian Children's Hospital. The primary outcome of the feasibility study is enrolment; the primary outcome of the main study is cost-effectiveness. Other secondary outcomes include the prevalence and severity of key symptoms (i.e. pain, nausea/vomiting and anxiety), efficacy of PIM interventions, patient safety, and parent satisfaction. DISCUSSION: This trial will be the first to evaluate the comparative effectiveness, both clinical and cost, of a PIM inpatient service. The evidence from this study will be useful to families, clinicians and decision makers, and will describe the clinical and economic value of PIM services for pediatric patients admitted to hospital.

Corrigendum to "Comparative effectiveness of pediatric integrative medicine as an adjunct to usual care for pediatric inpatients of a North American tertiary care centre: A study protocol for a pragmatic cluster controlled trial" [Contemp. Clin. Trials Commun. (2017) 12-18].

[This corrects the article DOI: 10.1016/j.conctc.2016.11.002.].

Protective effects of five allium derived organosulfur compounds against mutation and oxidation.

In this study, we examined the ability of five allium-derived organosulfur compounds to protect cells against mutation and oxidation. The compounds tested were 1-propylmercaptan (PM), dimethyl disulfide (DMDS), diallyl disulfide (DADS), propyl disulfide (PDS), and 2,5-dimethylthiophene (DMT). Our results showed that when used at concentrations of 100-400 µmol/l, the five compounds inhibited the mutagenicity of 4-nitroquinoline-N-oxide, a direct mutagen, and benzo[a]pyrene, an indirect mutagen, toward Salmonella typhimurium TA 98 and TA 100. Furthermore, at these concentrations, all five of the compounds protected HepG2 cells against tert-butyl hydroperoxide-induced oxidative cytotoxicity. The compounds likely enhanced cell viability by suppressing the formation of reactive oxygen species and the depletion of glutathione depletion in cells. DMT and PM inhibited mutation and oxidation to a greater extent than DMDS, DADS, and PDS. These results demonstrate for the first time that DMT and PM can contribute to the antimutagenic and the antioxidative property of Allium vegetables.

Music to reduce pain and distress in the pediatric emergency department: a randomized clinical trial.

IMPORTANCE: Many medical procedures aimed at helping children cause them pain and distress, which can have long-lasting negative effects. Music is a form of distraction that may alleviate some of the pain and distress experienced by children while undergoing medical procedures. OBJECTIVE: To compare music with standard care to manage pain and distress. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial conducted in a pediatric emergency department with appropriate sequence generation and adequate allocation concealment from January 1, 2009, to March 31, 2010. Individuals assessing the primary outcome were blind to treatment allocation. A total of 42 children aged 3 to 11 years undergoing intravenous placement were included. INTERVENTIONS: Music (recordings selected by a music therapist via ambient speakers) vs standard care. MAIN OUTCOMES AND MEASURES: The primary outcome was behavioral distress assessed blinded using the Observational Scale of Behavioral Distress-Revised. The secondary outcomes included child-reported pain, heart rate, parent and health care provider satisfaction, ease of performing the procedure, and parental anxiety. RESULTS: With or without controlling for potential confounders, we found no significant difference in the change in behavioral distress from before the procedure to immediately after the procedure. When children who had no distress during the procedure were removed from the analysis, there was a significantly less increase in distress for the music group (standard care group = 2.2 vs music group = 1.1, P < .05). Pain scores among children in the standard care group increased by 2 points, while they remained the same in the music group (P = .04); the difference was considered clinically important. The pattern of parent satisfaction with the management of children's pain was different between groups, although not statistically significant (P = .07). Health care providers reported that it was easier to perform the procedure for children in the music group (76% very easy) vs the standard care group (38% very easy) (P = .03). Health care providers were more satisfied with the intravenous placement in the music group (86% very satisfied) compared with the standard care group (48%) (P = .02). CONCLUSIONS AND RELEVANCE: Music may have a positive impact on pain and distress for children undergoing intravenous placement. Benefits were also observed for the parents and health care providers. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00761033.

The safety of pediatric acupuncture: a systematic review.

CONTEXT: Acupuncture is increasingly used in children; however, the safety of pediatric acupuncture has yet to be reported from systematic review. OBJECTIVE: To identify adverse events (AEs) associated with needle acupuncture in children. METHODS: Eighteen databases were searched, from inception to September 2010, irrespective of language. Inclusion criteria were that the study (1) was original peer-reviewed research, (2) included children from birth to 17 years, inclusively, (3) involved needle acupuncture, and (4) included assessment of AEs in a child. Safety data were extracted from all included studies. RESULTS: Of 9537 references identified, 450 were assessed for inclusion. Twenty-eight reports were included, and searches of reference lists identified 9 additional reports (total: 37). A total of 279 AEs were identified, 146 from randomized controlled trials, 95 from cohort studies, and 38 from case reports/series. Of the AEs, 25 were serious (12 cases of thumb deformity, 5 infections, and 1 case each of cardiac rupture, pneumothorax, nerve impairment, subarachnoid hemorrhage, intestinal obstruction, hemoptysis, reversible coma, and overnight hospitalization), 1 was moderate (infection), and 253 were mild. The mild AEs included pain, bruising, bleeding, and worsening of symptoms. We calculated a mild AE incidence per patient of 168 in 1422 patients (11.8% [95% confidence interval: 10.1-13.5]). CONCLUSIONS: Of the AEs associated with pediatric needle acupuncture, a majority of them were mild in severity. Many of the serious AEs might have been caused by substandard practice. Our results support those from adult studies, which have found that acupuncture is safe when performed by appropriately trained practitioners.