Challenges Enrolling Children Into Traumatic Brain Injury Trials: An Observational Study

ObjectivesIn preparation for a clinical trial of therapeutic agents for children with moderate‐to‐severe blunt traumatic brain injuries (TBIs) in emergency departments (EDs), we conducted this feasibility study to (1) determine the number and clinical characteristics of eligible children, (2) determine the timing of patient and guardian arrival to the ED, and (3) describe the heterogeneity of TBIs on computed tomography (CT) scans.MethodsWe conducted a prospective observational study at 16 EDs of children ≤ 18 years of age presenting with blunt head trauma and Glasgow Coma Scale scores of 3–12. We documented the number of potentially eligible patients, timing of patient and guardian arrival, patient demographics and clinical characteristics, severity of injuries, and cranial CT findings.ResultsWe enrolled 295 eligible children at the 16 sites over 6 consecutive months. Cardiac arrest and nonsurvivable injuries were the most common characteristics that would exclude patients from a future trial. Most children arrived within 2 hours of injury, but most guardians did not arrive until 2–3 hours after the injury. There was a substantial range in types of TBIs, with subdural hemorrhages being the most common.ConclusionEnrolling children with moderate‐to‐severe TBI into time‐sensitive clinical trials will require large numbers of sites and meticulous preparation and coordination and will prove challenging to obtain informed consent given the timing of patient and guardian arrival. The Federal Exception from Informed Consent for Emergency Research will be an important consideration for enrolling these children.Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/135996/1/acem13085_am.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/135996/2/acem13085.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/135996/3/acem13085-sup-0001-DataSupplementS1.pd

Clinically Significant Differences in Acute Pain Measured on Self-report Pain Scales in Children

Objectives The objective was to determine the minimum and ideal clinically significant differences (MCSD, ICSD) in pain intensity in children for the Faces Pain Scale–Revised (FPS-R) and the Color Analog Scale (CAS) and to identify any differences in these estimates based on patient characteristics. Methods This was a prospective study of children aged 4 to 17 years with acute pain presenting to two urban pediatric emergency departments. Participants self-reported their pain intensity using the FPS−R and CAS and qualitatively described their changes in pain. Changes in pain score reported using the FPS-R and CAS that were associated with “a little less” and “much less” pain (MCSD and ICSD, respectively) were identified using a receiver operating characteristic–based method and expressed as raw change score and percent reductions. Estimates of MCSD and ICSD were determined for each category of initial pain intensity (mild, moderate, and severe) and patient characteristics (age, sex, and ethnicity). Post hoc exploratory analyses evaluated categories of race, primary language, and etiology of pain. Results A total of 314 children with acute pain were enrolled; mean (±SD) age was 9.8 (±3.8) years. The FPS-R raw change score and percent reduction MCSD estimates were 2/10 and 25%, with ICSD estimates of 3/10 and 60%. For the CAS, raw change score and percent reduction MCSD estimates were 1/10 and 15%, with ICSD estimates of 2.75/10 and 52%. For both scales, raw change score and percent reduction estimates of the MCSD remained unchanged in children with either moderate or severe pain. For both scales, estimates of ICSD were not stable across categories of initial pain intensity. There was no difference in MCSD or ICSD based on age, sex, ethnicity, race, primary language, or etiology of pain. Conclusions The MCSD estimates can be expressed as raw change score and percent reductions for the FPS-R and CAS. These estimates appear stable for children with moderate to severe pain, irrespective of age, sex, and ethnicity. Estimates of ICSD were not stable across different categories of initial pain intensity, therefore limiting their potential generalizability

Defining No Pain, Mild, Moderate, and Severe Pain Based on the Faces Pain Scale-Revised and Color Analog Scale in Children With Acute Pain

Objectives: The aims of this study were to define the Faces Pain Scale-Revised (FPS-R) and Color Analog Scale (CAS) scores associated with no pain, mild pain, moderate pain, and severe pain in children with acute pain, and to identify differences based on age, sex, and ethnicity. Methods: We conducted a prospective observational study in 2 pediatric emergency departments of children aged 4 to 17 years with painful and nonpainful conditions. We assessed their pain intensity using the FPS-R, CAS, and qualitative measures. Pain score cut points that best differentiated adjacent categories of pain were identified using a receiver operating characteristic-based method. Cut points were compared within subgroups based on age, sex, and ethnicity. Results: We enrolled 620 patients, of whom 314 had painful conditions. The mean age was 9.2 years; 315 (50.8%) were in the younger age group (aged 4-7 years); 291 (46.8%) were female; and 341 (55%) were Hispanic. The scores best representing categories of pain for the FPS-R were as follows: no pain, 0 and 2; mild pain, 4; moderate pain, 6; and severe pain, 8 and 10. For the CAS, these were 0 to 1, 1.25 to 2.75, 3 to 5.75, and 6 to 10, respectively. Children with no pain frequently reported nonzero pain scores. There was considerable overlap of scores associated with mild and moderate pain. There were no clinically meaningful differences of scores representing each category of pain based on age, ethnicity, and race. Conclusions: We defined pain scores for the FPS-R and CAS associated with categories of pain intensity in children with acute pain that are generalizable across subgroups based on patient characteristics. There were minor but potentially important differences in pain scores used to delineate categories of pain intensity compared to prior convention