Effect of high-dose paracetamol on needle procedures in children with cancer--an RCT.

AIM: The aim was to investigate whether children experience less pain, fear and/or distress when they receive high-dose paracetamol compared with placebo, using a needle insertion in a subcutaneously implanted intravenous port as a model. METHODS: Fifty-one children ranging from 1 to 18 years of age being treated in a paediatric oncology setting were included consecutively when undergoing routine needle insertion into a subcutaneously implanted intravenous port. All children were subjected to one needle insertion following topical anaesthetic (EMLA) application in this double-blind, placebo-controlled RCT, comparing orally administered paracetamol (n = 24) 40 mg/kg body weight (max 2000 mg) with placebo (n = 27). The patients' pain, fear and distress were reported by parents, nurses and children (≥7 years of age) using 0- to 100-mm visual analogue scales (VAS). In addition, pain observation, procedure time and cortisol reduction were assessed. RESULTS: No differences between the paracetamol and the placebo group were found with respect to demographic characteristics. According to VAS reports, paracetamol did not reduce pain, fear and distress compared with placebo. Pain observation, cortisol reduction and procedure time did not differ between the study groups. CONCLUSION: Paracetamol provides no additive effect in reducing pain, fear and distress when combined with topical anaesthesia in children undergoing port needle insertion.

Pain in pediatric oncology-A Swedish nationwide follow-up study among nurses and physicians.

To examine nurses' and physicians' assessments of pain in children with cancer, and to identify the methods in use to diagnose, evaluate, and treat pain. In addition, to examine whether/how the healthcare professionals' assessment and management of pain has changed compared to 1995 and identify the needs for training. The study has a descriptive and comparative design. 363 nurses and physicians working with children with cancer in Sweden were invited to participate in April 2017. Participants answered an updated version of a questionnaire used in 1995 by Ljungman et al. focusing on the healthcare professionals' experience of pain among their patients, their pain treatment strategies, and need for training. 120 nurses and 65 physicians participated. Fifty percent of nurses and 55% of physicians answered that moderate-to-severe pain was experienced often or very often by children with cancer. Methods recommended in international guidelines to diagnose, evaluate, and treat pain were generally followed. Compared with findings from 1995 by Ljungman et al., nurses, and physicians assessed that moderate-to-severe pain was seen more often. The greatest need for training was reported for pharmacology, different routes for administration of opioids, treatment with nitrous oxide, and nonpharmacological interventions. Nurses and physicians assessed that moderate-to-severe pain is often present in children with cancer. More time to treat pain in the department and training in certain areas seem to be needed to improve pain management.

Parents' experiences of having their children take part in participatory action research creating a serious game about radiotherapy.

INTRODUCTION: Radiotherapy (RT) is one of several treatment modalities used for children diagnosed with cancer. Several studies have designed interventions aimed to alleviate the stress that can occur in conjunction with RT. To include children in the design of interventions is rare and dependent on the parents giving consent to participation in research on their children's behalf. The aim was to illuminate, from the parents' perspective, the experience of their children being part in the co-creation of a serious game and their previous experiences of RT. METHODS: Ten parents of children taking part in a participatory action research study of the development of a serious game were invited to an interview and seven parents consented. An inductive, manifest content analysis was performed. RESULTS: The analysis resulted in an overarching theme: Parents' pre-understanding from their child's cancer treatment created a sensitivity to their child's wishes and a willingness to contribute to science. Four categories are presented: Intrinsic factors influenced the intent to participate, Extrinsic factors that had an effect on participation, Parents role in the game development, and Radiotherapy impinged the child and the parent. CONCLUSION: To be able to pay it forward to healthcare and other families with a child diagnosed with cancer was a contributing factor for parents' willingness to consent to participation after their children had undergone RT, especially since their children wanted to do so. Parents indicated interest in the developmental process and in following their children being part of the creation of a serious game about RT. IMPLICATION FOR PRACTICE: To understand why parents allow their children to participate in studies creates opportunities for the research community to structure studies that facilitate participation.

Randomized cross-over study investigating the tolerability and side effects of an intra-oral air-cooling device compared to ice in healthy volunteers.

Oral cryotherapy (OC) is a common preventive treatment of oral mucositis (OM) and is recommended in international guidelines. Ice and air OC have previously been shown to result in temperature reductions of 8.1-12.9 °C, and 14.5 °C, respectively, in healthy volunteers. However, no direct comparison between these two modalities has been performed. The primary aim was to investigate the tolerability and side effects of air OC using an intra-oral air-cooling (IOAC) device compared with ice OC. The secondary aim was to evaluate the temperature reduction in the mouth for the two respective methods. Cross-over study with randomization to order of treatment, in 15 healthy volunteers. We evaluated the self-reported intensity, frequency, and discomfort for 13 pre-defined side effects used in previous studies. All participants were able to complete both OC sessions, although one participant required reduced airflow in the air OC arm. The subjects reported more discomfort from being cold, having sensitive teeth, and numbness in the ice OC group, while they reported more discomfort from swallowing when subjected to air OC. No significant difference in the median temperature reduction was detected in the two modalities, except for the dorsal posterior part of the tongue where temperature reduction was larger in the ice OC group. We found that oral cooling using a new IOAC device was tolerated and seems to be safe in healthy volunteers.

Primary evaluation of an air-cooling device to reduce oral mucositis: a pilot study in healthy volunteers.

Oral mucositis is a common side effect of chemo and radiotherapy causing painful ulcers in the oral mucosa. One of the preventive treatments recommended in international guidelines is oral cryotherapy (OC). Randomized clinical trials on OC have used ice and ice-chips to cool the mouth, but this cooling method can be difficult for the patients to tolerate. Studies have shown that OC with ice for a period of 60 min reduces the oral temperature by 12.9 °C. The aim of this pilot study was to evaluate the temperature reduction and tolerability of OC using an intra-oral air-cooling (IOAC) device in healthy volunteers. Twelve healthy volunteers, mean age 35.4 years, were included in the study. They were treated with OC using the IOAC device for 60 min. Measurements of temperature were obtained at baseline, 5 and 60 min using a FLIR® C2 camera. After the OC session, tolerability and adverse events were documented using a questionnaire. All participants were able to use the device for 60 min. The overall temperature reduction after 5 min of OC was 10.7°C (p < 0.01) and after 60 min 14.5°C (p < 0.01). The most common adverse events were bad fit of the mouthpiece (n = 6), hypersalivation (n = 6), and difficulties swallowing (n = 5). The oral device reduced the temperature of the oral mucosa as much as treatment with ice with tolerable adverse events. The mouthpiece will be remodeled to improve tolerability before further studies are conducted.

Empirically derived psychosocial states among adolescents diagnosed with cancer during the acute and extended phase of survival.

BACKGROUND: To, during the acute and extended phase of survival, identify psychosocial states among adolescents diagnosed with cancer and to analyse these in relation to demographic and clinical characteristics and self-reported depression. PATIENTS AND METHODS: Participants completed the Hospital Anxiety and Depression Scale and two subscales, Vitality and Mental Health, in the SF-36 4-8 weeks (T1) (n = 61), 6 (T2) (n = 57), 12 (T3) (n = 50), and 18 (T4) months (n = 48) after diagnosis. I-State as Object of Analysis was used to identify a finite set of states based on three dimensions. Cluster analysis was carried out using Ward's method. RESULTS: Five states were obtained: psychosocial dysfunction (state A) and poor (B), incomplete (C), good (D), and excellent (E) psychosocial function. At T1, more adolescents than expected by chance were in states A (P < 0.05) and C (P < 0.01) and fewer in states D (P < 0.05) and E (P < 0.001). At T4, more adolescents than expected by chance were in state E (P < 0.001) and fewer in state C (P < 0.05). Female gender and being in late adolescence when diagnosed is related to worse psychosocial function. CONCLUSION: The findings provide support for subgroups of adolescents whose level of vitality, mental health, and anxiety differ during the acute and extended phase of survival of cancer. Clinical interventions tailored to the level of impairment as determined by the clusters may result in better psychosocial outcomes.

Randomized interventions for needle procedures in children with cancer.

The aim of this study was to examine whether children experience less fear, distress and pain connected to a routine needle insertion in an intravenous port when subjected to an intervention: blowing soap bubbles or having a heated pillow vs. standard care. Twenty-eight children, 2-7 years, cared for at a paediatric oncology unit, undergoing a routine needle insertion in an intravenous port were included consecutively. All children were subjected to two needle insertions; at the first they received standard care, and at the second standard care + a randomized intervention. Parents and nurses assessed children's fear, distress and pain on 0-100 mm visual analogue scales. According to parents' report, children experienced less fear when subjected to intervention vs. standard care reported by parents (P < 0.001). Children also experienced less fear (P < 0.05) and distress (P < 0.05) when subjected to standard care + blowing soap bubbles vs. standard care (n = 14), and less fear when subjected to standard care + heated pillow vs. standard care (P < 0.05). Nurses' reports did not show any differences for standard care + intervention vs. standard care. Blowing soap bubbles or having a heated pillow is more effective than standard care in reducing children's fear and distress in needle procedures, according to parents' report.

The relationship between fear and pain levels during needle procedures in children from the parents' perspective.

BACKGROUND: The primary objective was to determine the levels of and potential relationships between procedure-related fear and pain in children. Secondary objectives were to determine if there are associations between the child's age and sex, diagnostic group, time since diagnosis, time since last needle insertion, cortisol levels and the parent's fear level in relation to fear and pain. METHODS: The child's level of pain and fear was reported by parents on 0-100 mm visual analogue scales (VAS). One hundred and fifty-one children were included consecutively when undergoing routine needle insertion into a subcutaneously implanted intravenous port. All children were subjected to one needle insertion following topical anaesthesia (EMLA) application. The effect of the child's age and sex, diagnostic group, time since diagnosis, time since last needle insertion, cortisol change levels and the parent's fear level, on fear and pain levels was investigated with multiple regression analysis. RESULTS: The needle-related fear level (VAS mean 28 mm) was higher than the needle-related pain level (VAS mean 17 mm) when topical anaesthesia is used according to parents' reports (n = 151, p < 0.001). With fear as the dependent variable, age and pain were significantly associated and explained 33% of the variance, and with pain as the dependent variable, fear, parents' fear and change in cortisol level were significantly associated and explained 38% of the variance. CONCLUSIONS: According to parents, children experienced more fear than pain during needle insertion when topical anaesthesia is used. Therefore, in addition to pain management, an extended focus on fear-reducing interventions is suggested for needle procedures.

Treating youth in pain: Comparing tailored behavioural medicine treatment provided by physical therapists in primary care with physical exercises.

OBJECTIVES: To study the efficacy of tailored behavioural medicine treatment within a physical therapy framework. METHODS: The study was a randomized controlled study (RCT): tailored behavioural medicine treatment (EXT) delivered by physical therapists (PTs) was compared with exercise-based treatment (CT). Thirty-two adolescents (mean age 14.3 years) with persistent pain participated. Data on pain-related disability and school attendance (primary outcomes), pain intensity, catastrophizing, fear of movement and self-efficacy were collected. RESULTS: The pain-related disability measured by the Functional Disability Inventory (FDI) resulted in mean score change of EXT = -18 and CT = -11, respectively. A significant change within both groups was found (EXT p = 0.003, CT p = 0.001), and a large effect size for FDI between the conditions was demonstrated (AUC of 0.77). For school attendance post-treatment, no difference was found between conditions. For secondary outcomes, a significant improvement in pain intensity and pain catastrophizing was found for the EXT and self-efficacy for the CT groups but no statistically significant difference between the two conditions was detected. Caution should be given to the small sample size, as it may affect the interpretation and generalizability of the results. CONCLUSION: In this study, differences between tailored behavioural medicine treatment delivered by PTs and exercise-based treatment could not be demonstrated, although the effect size was large. Patients who received either treatment demonstrated significant changes over time in pain-related disability. The low number of participants and suboptimal tailoring of the psychological components may partly explain the failure to demonstrate differences between groups, and future studies are warranted.

Treatment of pain in pediatric oncology: a Swedish nationwide survey.

Pain treatment is a crucial aspect in the care of children with cancer and there are many studies demonstrating inefficient pain treatment. In this study, questionnaires dealing with pain treatment of children with malignant diseases were sent to all (47) pediatric departments in Sweden. The aims of this nationwide survey were to evaluate the extent and causes of pain, the use of methods for pain evaluation (e.g. analysis of type of pain and monitoring of pain intensity), principles of pain management, side effects of pain treatment and the educational needs of physicians and nurses regarding these issues. The response rate was 100%. Answers from physicians and nurses reveal that pain is a common symptom during different periods of cancer treatment. Pain due to treatment and procedures is a greater problem than pain due to the malignant disease itself. Instruments for the measurement of pain intensity and analysis of the type of pain are still rarely used. Most physicians (63%) follow the analgesic 'ladder' principle recommended by World Health Organization (WHO). According to a majority of physicians and nurses (72%), pain could be treated more effectively than it is presently, and 64% state that they need more time for the management of pain. Both physicians and nurses state that they need additional education in different areas of pain evaluation and pain treatment. Swedish treatment practices for the management of pediatric cancer pain roughly follow the published guidelines, but many improvements are still necessary.

Midazolam nasal spray reduces procedural anxiety in children.

OBJECTIVE: Anxiety and pain even in minor procedures are still great problems in pediatrics, not least in pediatric oncology. Conscious sedation is indicated when other means to overcome a child's fear fail. The aim of this study was to investigate whether intranasal administration of midazolam given before insertion of a needle in a subcutaneously implanted central venous port could reduce anxiety, discomfort, pain, and procedure problems. METHOD: Forty-three children with cancer participated in this randomized, double-blind, placebo-controlled, crossover study in which nasal administration of midazolam spray,.2 mg/kg body weight, was compared with placebo. Children, parents, and nurses completed a visual analog scale questionnaire to evaluate efficacy. RESULTS: Parents and nurses reported reduced anxiety, discomfort, and procedure problems for children in the midazolam group and would prefer the same medication at next procedure. They also reported pain reduction. Children reported reduced anxiety and procedure problems but reduction of pain and discomfort was not significant. No serious or unexpected side effects occurred. Nasal discomfort was the most common side effect (17/38 approximately 45%) and the primary reason for dropouts (8/43 approximately 19%). Anxiety varied with age but not with gender. When anxiety increased, the differences between midazolam and placebo increased. CONCLUSION: Nasal midazolam spray offers relief to children anxious about procedures, such as insertion of a needle in a subcutaneously implanted intravenous port, venous blood sampling, venous cannulation, etc. Its use, however, may be limited by nasal discomfort in some patients for whom rectal and oral routes might be alternatives.

The state of research into children with cancer across Europe: new policies for a new decade.

Overcoming childhood cancers is critically dependent on the state of research. Understanding how, with whom and what the research community is doing with childhood cancers is essential for ensuring the evidence-based policies at national and European level to support children, their families and researchers. As part of the European Union funded EUROCANCERCOMS project to study and integrate cancer communications across Europe, we have carried out new research into the state of research in childhood cancers. We are very grateful for all the support we have received from colleagues in the European paediatric oncology community, and in particular from Edel Fitzgerald and Samira Essiaf from the SIOP Europe office. This report and the evidence-based policies that arise from it come at a important junction for Europe and its Member States. They provide a timely reminder that research into childhood cancers is critical and needs sustainable long-term support.

Positive and negative consequences with regard to cancer during adolescence. Experiences two years after diagnosis.

OBJECTIVES: The purpose was to explore negative and positive consequences of cancer during adolescence experienced two years after diagnosis. METHODS: Two years after diagnosis 38 persons, 15-21 years old, were asked two questions over the telephone: What, if anything, is bad for you due to the cancer disease? and What, if anything, is good for you due to the cancer disease? The answers were analysed by content analysis. RESULTS: Four categories of negative experiences were identified: a problematic body; unpleasant thoughts and feelings; outside the circle of friends; and difficulties with schoolwork. Six categories of positive experiences were identified: a more positive view of life; good self-esteem; knowledge and experience with regard to disease and hospital care; good relations; broader perspectives; and material gains. CONCLUSIONS: Two years after diagnosis those struck by cancer during adolescence experience not only a number of negative, but also positive, consequences of the cancer disease and its treatment.

Compliance in teenagers with coeliac disease--a Swedish follow-up study.

A group of 47 children with coeliac disease, born between 1973 and 1978 in the Swedish county of Västmanland, participated in a controlled questionnaire study. Health, self-esteem, knowledge of the disease and dietary compliance were investigated. The children with coeliac disease were otherwise just as healthy as the control children. Growth and self-esteem were normal. Good knowledge of coeliac disease and dietary treatment was found in 87% of children and dietary compliance was 81%. Girls and younger children (12-14 years) were more compliant than boys and older children (15-17 years). Compliance correlated positively to knowledge.

Acute and postoperative pain in children: a Swedish nationwide survey.

UNLABELLED: Many studies demonstrate inadequate pain treatment in children. The aim of this nationwide survey was to evaluate the prevalence of acute and postoperative pain in children; extent of, and reasons for, inadequate pain therapy; therapy methods; pain-management structure; and the need for education of healthcare professionals. Questionnaires concerning these points were sent to all departments in Sweden involved in the treatment of children. The response rate was 75% (299/ 395). Answers from physicians and nurses showed that, despite treatment, moderate to severe pain occurred in 23% of patients with postoperative pain and 31% of patients with pain of other origin. Postoperative pain seemed to be a greater problem in units where children were treated along with adults and in departments where fewer children were treated. According to 45% of physicians and nurses, treatment of pain could often or always be managed more efficiently. Pain assessments were performed regularly in 43% of all departments, but pain measurement was less frequent; 3% of the departments had no formal organization for pain management; and 15% never or infrequently used potent opioids. Educational needs were high. Insufficient pain treatment seemed to be mostly related to organizational aspects, such as inadequate prescriptions. Anxiety in children or parents also contributed to ineffective pain treatment. Swedish treatment practices for the management of pain in children roughly follow the published guidelines, but many improvements are still necessary. CONCLUSION: Acute pain in children is still undertreated in Swedish hospitals. This seems to be related mainly to organizational aspects.

Pain variations during cancer treatment in children: a descriptive survey.

Structural interviews were conducted with 66 children and their families to investigate how the experience of pain varied during cancer treatment. At diagnosis, 49% experienced cancer-related pain. Intense pain was more common at the beginning of treatment when it was often believed that pain treatment could be better. Procedure- and treatment-related pain were the major problems initially. Procedural pain gradually decreased, but treatment-related pain was constant and dominating. For some procedures pain was rated highest initially, lower during the second period, and higher again during the final part of treatment. Pain intensity measurement was seldom performed, and parents increasingly considered themselves better judges of their child's pain than professionals. Increased knowledge about pain and pain treatment in children with cancer, where most pain is iatrogenic, will help us to meet the needs and demands of children and parents, and to reduce pain to a minimum.