Hsing Jou

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.

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 childrens 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.

Survey of Sedation and Analgesia Practice Among Canadian Pediatric Critical Care Physicians

Background: Despite the fact that almost all critically ill children experience some degree of pain or anxiety, there is a lack of high-quality evidence to inform preferred approaches to sedation, analgesia, and comfort measures in this environment. We conducted this survey to better understand current comfort and sedation practices among Canadian pediatric intensivists. Methods: The survey was conducted after a literature review and initial focus groups. The survey was then pretested and validated. The final survey was distributed by email to 134 intensivists from 17 PICUs across Canada using the Research Electronic Data Capture system. Results: The response rate was 73% (98/134). The most commonly used sedation scores are Face, Legs, Activity, Cry, and Consolability (42%) and COMFORT (41%). Withdrawal scores are commonly used (65%). In contrast, delirium scores are used by only 16% of the respondents. Only 36% of respondents have routinely used sedation protocols. The majority (66%) do not use noise reduction methods, whereas only 23% of respondents have a protocol to promote day/night cycles. Comfort measures including music, swaddling, soother, television, and sucrose solutions are frequently used. The drugs most commonly used to provide analgesia are morphine and acetaminophen. Midazolam and chloral hydrate were the most frequent sedatives. Conclusion: Our survey demonstrates great variation in practice in the management of pain and anxiety in Canadian PICUs. Standardized strategies for sedation, delirium and withdrawal, and sleep promotion are lacking. There is a need for research in this field and the development of evidence-based, pediatric sedation and analgesia guidelines.

Prospective cohort study on noise levels in a pediatric cardiac intensive care unit

Purpose: To describe noise levels in a pediatric cardiac intensive care unit, and to determine the relationship between sound levels and patient sedation requirements. Materials and Methods: Prospective observational study at a pediatric cardiac intensive care unit (PCICU). Sound levels were measured continuously in slow A weighted decibels dB(A) with a sound level meter SoundEarPro® during a 4‐week period. Sedation requirement was assessed using the number of intermittent (PRNs) doses given per hour. Analysis was conducted with autoregressive moving average models and the Granger test for causality. Results: 39 children were included in the study. The average (SD) sound level in the open area was 59.4 (2.5) dB(A) with a statistically significant but clinically unimportant difference between day/night hours (60.1 vs. 58.6; p‐value < 0.001). There was no significant difference between sound levels in the open area/single room (59.4 vs. 60.8, p‐value = 0.108). Peak noise levels were > 90 dB. There was a significant association between average (p‐value = 0.030) and peak sound levels (p‐value = 0.006), and number of sedation PRNs. Conclusion: Sound levels were above the recommended values with no differences between day/night or open area/single room. High sound levels were significantly associated with sedation requirements.

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.].

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 Childrens 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.

Evaluation of measurement properties of pediatric acute diarrheal severity scoring systems

Methods Medline, EMbase and the Cochrane library were searched using a highly sensitive search filter developed by Terwee et al. to identify studies that evaluated measurement properties. This search filter was combined with the names of ten pre-identified scales of pediatric diarrhea severity. Reference lists from included articles and the original publications for the ten diarrhea scales were also reviewed. Eligibility criteria were: 1) ability to develop or evaluate the measurement properties – i.e. content validity, construct validity, reliability or responsiveness – of a measurement instrument; 2) ability to measure severity of diarrhea/gastroenteritis; and 3) ability of the scale to be developed or adapted for the pediatric population (0-18 y/o). The methodological quality of the included studies and the results of measurement properties were appraised using checklists from the COnsensus-based Standards for the selection of health Measurement Instruments (COSMIN) group. Results The search yielded 98 potentially relevant articles, of which only 2 articles met inclusion criteria. Studies that did not evaluate measurement properties of the identified scales or did not measure pediatric diarrhea were excluded. Both included studies evaluated the measurement properties of the “Modified Vesikari score” (MVS). Assessment of methodological quality determined that both studies were of ‘poor’ quality in most properties except for hypothesis testing, which was rated as ‘good’. MVS was rated as positive for face and construct validity and indeterminate for internal consistency and interpretability.