Neil L. Schechter

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.

The Undertreatment of Pain in Children: An Overview

At the present time, the management of pain in children is not addressed with the same vigor and enthusiasm as is the management of pain in adults. Limited accessible information and limited research have allowed inaccurate and inadequate information to persist, which serves to justify the status quo. The personal nature of pain and the complexity of assessing it have offered further obstacles. Changes are occurring, however, which will dramatically alter present practice. It will soon be unacceptable socially and medically to ignore the suffering of children.

Pain Reduction During Pediatric Immunizations: Evidence-Based Review and Recommendations

The pain associated with immunizations is a source of anxiety and distress for the children receiving the immunizations, their parents, and the providers who must administer them. Preparation of the child before the procedure seems to reduce anxiety and subsequent pain. The limited available data suggest that intramuscular administration of immunizations should occur in the vastus lateralis (anterolateral thigh) for children <18 months of age and in the deltoid (upper arm) for those >36 months of age. Controversy exists in site selection for 18- to 36-month-old children. A number of studies suggest that the ventrogluteal area is the most appropriate for all age groups. Longer needles are usually associated with less pain and less local reaction. During the injection, parental demeanor clearly affects the childs pain behaviors. Excessive parental reassurance, criticism, or apology seems to increase distress, whereas humor and distraction tend to decrease distress. Distraction techniques vary with the age, temperament, and interests of the child, but their efficacy is well supported in the literature. Sucrose solution instilled directly into the mouth or administered on a pacifier reduces evidence of distress reliably in children <6 months of age and should be used routinely. Although there is no perfect topical anesthetic available at this time, selective use for children who are particularly fearful or who have had negative experiences in the past is highly endorsed. Pressure at the site, applied with either a device or a finger, clearly reduces pain. Finally, in the era of multiple injections, it seems that parents prefer that multiple injections be given simultaneously, rather than sequentially, if there are enough personnel available. Immunizations are stressful for many children; until new approaches are developed, systematic use of available techniques can significantly reduce the burden of distress associated with these procedures.

Chronic pain is a manifestation of the Ehlers-Danlos syndrome

The Ehlers-Danlos syndrome (EDS) is a group of heritable systemic disorders of connective tissue manifesting joint hypermobility, skin extensibility, and tissue fragility. Although the presence of pain has been documented in the various types of the EDS, its natural history, distribution, and management have not been defined. We conducted a structured interview in 51 individuals affected with different types of EDS. Affected individuals reported chronic pain of early onset involving most frequently the shoulders, hands, and knees. Pain was generally refractory to a variety of pharmacologic and physical interventions. Chronic pain is a common manifestation of EDS.

Oral transmucosal fentanyl citrate for premedication of children undergoing laceration repair

STUDY OBJECTIVE To evaluate the safety and efficacy of two doses of oral transmucosal fentanyl citrate (OTFC) for premedication of children undergoing laceration repair. DESIGN Prospective, randomized, nonblinded study. SETTING Urban pediatric emergency department. PARTICIPANTS Thirty children aged 2 to 8 years requiring laceration repair. INTERVENTIONS Premedication with either 10 to 15 micrograms/kg or 15 to 20 micrograms/kg of OTFC. RESULTS Activity score, vital signs, oxygen saturation, and pain scores were recorded before and after administration of OTFC. Activity scores decreased significantly 15 to 60 minutes after OTFC. The physician suturing the wound rated the childs sedation/pain control as excellent or good in 83% of patients. Vital signs changes were not clinically remarkable. Oxygen saturations remained at 95% or more except in one child who experienced a transient decrease to 91%. Adverse effects were not serious but included vomiting in 20% of the lower-dose group and 47% of the higher-dose group. There were no significant differences between dose groups for activity or pain score changes, physician assessment, discharge times, or adverse events. CONCLUSION Both doses of OTFC reduced activity with comparable efficacy, with no serious vital signs changes. However, the higher-dose group had a greater number (P = NS) of adverse effects.

The use of patient-controlled analgesia in adolescents with sickle cell pain crisis: A preliminary report

Abstract A pilot study using patient-controlled analgesia (PCA) in adolescents in pain crisis associated with sickle cell disease was undertaken in preparation for a randomized controlled clinical trial. The three patients in this pilot study all were capable of appropriately using the PCA machine. Our preliminary experience revealed that higher than expected doses of morphine were required for pain control but that morphine requirements decreased on successive days as the pain crisis resolved, implying that the drug was not being abused. Because the infuser was not developed for a pediatric population, there were limitations on the precision with which a four-hour maximum dose could be set. Finally, we encountered such deeply entrenched attitudes in the medical staff about the addiction proneness of adolescents with sickle cell disease that the study was rejected by one of the hospitals involved. A formal study is in preparation to assess the efficacy of PCA as compared with other forms of treatment for sickle cell pain crises.

Retrospective evaluation of pain assessment and treatment for acute vasoocclusive episodes in children with sickle cell disease.

This study was conducted to assess the care of pediatric patients hospitalized for sickle cell disease‐related vasoocclusive episodes (VOE). The aim of this research was to illustrate the course of pain scores and methods of therapeutic intervention during hospitalization.

From the Ouchless Place to Comfort Central: The Evolution of a Concept

Although the past 20 years have yielded an outpouring of research on pain management in children, this information is often not applied uniformly to children in the hospital. To address this deficiency, we developed a systematic institution-wide program to reduce pain in all children in the hospital. Our goal was to create a setting in which attention to pain control and comfort measures would be inherent in all inpatient encounters. We labeled the inpatient unit in which this concept evolved as the “Ouchless Place” and described the program and its development in a 1997 Pediatrics article. In this article we describe the further evolution of that concept in light of the broader changes that have occurred in the field of pain management and in our community. The development of a new childrens hospital allowed us to examine what we had learned from our previous experience and modify our program on the basis of that review. This new initiative was renamed “Comfort Central,” recognizing that although no inpatient experience could be entirely “ouchless,” we could still pledge to families that we were attentive to pain and would provide the most comfort that we could. Specific changes that were put in place in our model included the acquisition of administrative authority to mandate change; the extension of our program to the laboratory, outpatient clinics, and physician offices; the incorporation of newer, more active educational models; increased emphasis on collaboration with other services; increased visibility of pain-relief efforts; and development of an ongoing quality improvement program that monitors the efficacy of pain-relief initiatives in the institution. The elements of this program may be applicable to other health care systems that desire to develop a more cohesive system-wide approach to pain reduction in those for whom they provide care.

Educational Outreach to Reduce Immunization Pain in Office Settings

OBJECTIVE: The goal was to examine the impact of a teaching module on immunization pain reduction practices in pediatric offices 1 and 6 months after the intervention. METHODS: Fourteen practices were selected randomly to receive a 1-hour teaching session on immunization pain reduction techniques, and 13 completed the study. Before the intervention, telephone interviews were conducted with parents concerning their childrens recent immunization experiences. At 1 and 6 months after the intervention, parents of children who had recent immunizations were interviewed by using the same questionnaires. Clinicians also were surveyed at baseline and at 6 months. RESULTS: A total of 839 telephone interviews and 92 clinician surveys were included. Significant changes from baseline were identified at 1 and 6 months after the intervention. At 1 month, parents were more likely to report receiving information (P = .04), using strategies to reduce pain (P < .01), learning something new (P < .01), using a ShotBlocker (P < .01), using sucrose (P < .01), and having higher levels of satisfaction (P = .015). At 6 months, all rates remained significantly higher than baseline findings (all P < .01) except for satisfaction. Clinician surveys revealed significant increases in the use of longer needles, sucrose, pinwheels, focused breathing, and ShotBlockers at 6 months. CONCLUSIONS: A 1-hour teaching session had measurable effects on the use of pain-reducing strategies at 1 and 6 months after the intervention. This research supports the hypothesis that small-group teaching sessions at the site of care can be associated with changes in practice behaviors.

Pediatric Pain Screening Tool: rapid identification of risk in youth with pain complaints.

Abstract Moderate to severe chronic pain is a problem for 1.7 million children, costing