Gustaf Ljungman

Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations

UNLABELLED Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 26 professionals from academia, governmental agencies, and the pharmaceutical industry participated in a 2-stage Delphi poll and a consensus meeting that identified core outcome domains and measures that should be considered in clinical trials of treatments for acute and chronic pain in children and adolescents. Consensus was refined by consultation with the international pediatric pain community through announcement of our recommendations on the Pediatric Pain List and inviting and incorporating comments from external sources. There was consensus that investigators conducting pediatric acute pain clinical trials should consider assessing outcomes in pain intensity; global judgment of satisfaction with treatment; symptoms and adverse events; physical recovery; emotional response; and economic factors. There was also agreement that investigators conducting pediatric clinical trials in chronic and recurrent pain should consider assessing outcomes in pain intensity; physical functioning; emotional functioning; role functioning; symptoms and adverse events; global judgment of satisfaction with treatment; sleep; and economic factors. Specific measures or measurement strategies were recommended for different age groups for each domain. PERSPECTIVE Based on systematic review and consensus of experts, core domains and measures for clinical trials to treat pain in children and adolescents were defined. This will assist in comparison and pooling of data and promote evidence-based treatment, encourage complete reporting of outcomes, simplify the review of proposals and manuscripts, and facilitate clinicians making informed decisions regarding treatment.

Pain in paediatric oncology: interviews with children, adolescents and their parents

Ljungman G, Gordh T, Sörensen S, Kreuger A. Pain in paediatric oncology: interviews with children, adolescents and their parents. Acta Pædiatr 1999; 88: 623‐30. Stockholm. ISSN 0803‐5253

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 childs 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≈45%) and the primary reason for dropouts (8/43≈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.

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

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.

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

Structured 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 childs 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.

Treatment of pain in pediatric oncology: a Swedish nationwide survey

&NA; 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.

Does time heal all wounds? A longitudinal study of the development of posttraumatic stress symptoms in parents of survivors of childhood cancer and bereaved parents.

A lack of longitudinal studies has hampered the understanding of the development of posttraumatic stress symptoms (PTSS) in parents of children diagnosed with cancer. This study examines level of PTSS and prevalence of posttraumatic stress disorder (PTSD) from shortly after diagnosis up to 5 years after end of treatment or childs death, in mothers and fathers.

Pain in Pediatric Oncology: Do the Experiences of Children and Parents Differ from Those of Nurses and Physicians?

Diagnosis and treatment of pain are central components in the care of children withcancer. The aim of the present study was to compare the viewpoints of children andparents with those of professionals, on different aspects of pain in children with cancer.Information was collected through questionnaires and interviews. In particular, wefocused on the extent and causes of pain, strategies to reduce procedural pain, painevaluation, and attitudes to pain treatment.We found that both families and professionals shared the opinion that pain was acommon symptom during different phases of cancer treatment but, surprisingly, profes-sionals regarded it as more frequent than families. The groups agreed that treatmentrelated pain is the most critical problem, followed by procedure and cancer relatedpain. Concerning strategies to decrease procedural pain, there was a high concordancein views between groups. Nurses and physicians more often claimed that failing paintreatment was associated with psychological factors such as high levels of anxiety inparents and children, loneliness, and lack of preparation. The self-report, according toboth parents and professionals, is a feasible procedure even in young children from 4years of age. Both groups asserted that parents were better in ascertaining the extent oftheir childs pain. In conclusion, although the families and professionals in this study have many com-parable views concerning pain in children with cancer, divergences also exist. Toacquire a more accurate picture of the situation we must focus on the views of the chil-dren first, and then those of parents and professionals. Atendency to overestimate theproblems was observed in professionals. Hopefully this reflects a keen awareness ofthe current situation.

Internet-based guided self-help for parents of children on cancer treatment : A randomized controlled trial

The aim of the study was to investigate the feasibility and preliminary efficacy of an Internet‐based guided self‐help intervention for posttraumatic stress symptoms (PTSS) and related symptoms in parents of children on cancer treatment.

Objective and Subjective Factors as Predictors of Post-Traumatic Stress Symptoms in Parents of Children with Cancer – A Longitudinal Study

Background Parents of children with cancer report post-traumatic stress symptoms (PTSS) years after the childs successful treatment is completed. The aim of the present study was to analyze a number of objective and subjective childhood cancer-related factors as predictors of parental PTSS. Methods Data were collected from 224 parents during and after their childs cancer treatment. Data sources include self-report questionnaires and medical records. Results In a multivariate hierarchical model death of the child, parents perception of child psychological distress and total symptom burden predicted higher levels of PTSS. In addition, immigrants and unemployed parents reported higher levels of PTSS. The following factors did not predict PTSS: parent gender, family income, previous trauma, childs prognosis, treatment intensity, non-fatal relapse, and parents satisfaction with the childs care. Conclusions Although medical complications can be temporarily stressful, a parents perception of the childs distress is a more powerful predictor of parental PTSS. The vulnerability of unemployed parents and immigrants should be acknowledged. In addition, findings highlight that the death of a child is as traumatic as could be expected.