RESUMEN
BACKGROUND: Intravenous ketorolac is commonly used for treating migraine headaches in children. However, the prerequisite placement of an intravenous line can be technically challenging, time-consuming, and associated with pain and distress. Intranasal ketorolac may be an effective alternative that is needle-free and easier to administer. We aimed to determine whether intranasal ketorolac is non-inferior to intravenous ketorolac for reducing pain in children with migraine headaches. METHODS: We conducted a randomized double-blind non-inferiority clinical trial. Children aged 8-17 years with migraine headaches, moderate to severe pain, and requiring parenteral analgesics received intranasal ketorolac (1 mg/kg) or intravenous ketorolac (0.5 mg/kg). Primary outcome was reduction in pain at 60 min after administration measured using the Faces Pain Scale-Revised (scored 0-10). Non-inferiority margin was 2/10. Secondary outcomes included time to onset of clinically meaningful decrease in pain; ancillary emergency department outcomes (e.g. receipt of rescue medications, headache relief, headache freedom, percentage improvement); 24-h follow-up outcomes; functional disability; and adverse events. RESULTS: Fifty-nine children were enrolled. We analyzed 27 children who received intranasal ketorolac and 29 who received intravenous ketorolac. The difference in mean pain reduction at 60 min between groups was 0.2 (95% CI -0.9, 1.3), with the upper limit of the 95% CI being less than the non-inferiority margin. There were no statistical differences between groups for secondary outcomes. CONCLUSIONS: Intranasal ketorolac was non-inferior to intravenous ketorolac for reducing migraine headache pain in the emergency department.
Asunto(s)
Ketorolaco , Trastornos Migrañosos , Antiinflamatorios no Esteroideos/uso terapéutico , Niño , Método Doble Ciego , Humanos , Ketorolaco/efectos adversos , Trastornos Migrañosos/tratamiento farmacológico , Dolor/tratamiento farmacológico , Resultado del TratamientoRESUMEN
OBJECTIVES: We aimed to describe the analgesic efficacy, duration of analgesia, and adverse event profile associated with intranasal hydromorphone in children with acute pain presenting to an emergency department. METHODS: Prospective dose titration pilot study of otherwise healthy children 4 to 17-years-old with moderate to severe pain who required a parenteral opioid. All patients received an initial intranasal hydromorophone dose of 0.03â¯mg/kg. The need for additional analgesia was assessed at 15 and 30â¯min; an additional 0.015â¯mg/kg was given at each assessment, if required. Need for rescue analgesic, pain intensity and adverse events were assessed until 6â¯h after hydromorphone administration or until patients were discharged, underwent a procedure to treat their painful condition, or received a rescue analgesic. RESULTS: We enrolled 35 children. Fifteen, 11, and 9 children required a total dose of 0.03, 0.045, and 0.06â¯mg/kg, respectively. Patients in each dose group experienced an absolute decrease in pain score of ≥3/10 and percent reduction >40% within 5-15â¯min of completing dose-titration administration of hydromorphone. Duration of analgesia (i.e. time until rescue analgesic administered) >1â¯h was observed in 85.7% of patients. Patients not requiring rescue analgesics had mild or no pain until discharged or their painful conditions were treated. Three (8.6%) patients required a rescue analgesic <1â¯h after hydromorphone administration. There were no major adverse events. CONCLUSIONS: Intranasal hydromorphone led to rapid, clinically significant and frequently sustained decreases in pain intensity in children. No major adverse events were observed in this preliminary sample. Clinical Trials Registration Number: NCT02437669.
Asunto(s)
Dolor Agudo/tratamiento farmacológico , Analgésicos Opioides/administración & dosificación , Hidromorfona/administración & dosificación , Administración Intranasal , Adolescente , Niño , Preescolar , Servicio de Urgencia en Hospital , Femenino , Humanos , Masculino , New York , Manejo del Dolor , Dimensión del Dolor , Proyectos Piloto , Estudios Prospectivos , Factores de Tiempo , Resultado del TratamientoRESUMEN
BACKGROUND: Despite being an effective analgesic for children with fractures, some clinicians may avoid prescribing ibuprofen due to its potentially harmful effect on bone healing. OBJECTIVE: To determine if exposure to ibuprofen is associated with an increased risk of bone healing complications in children with fractures. METHODS: We performed a retrospective study of children aged 6 months to 17 years who presented to the pediatric emergency department (PED) with a fracture of the tibia, femur, humerus, scaphoid, or fifth metatarsus and who followed up with the orthopedic service. We chose these fractures due to their higher risk for complications. We classified patients as exposed if they received ibuprofen in the PED or during hospitalization or were prescribed ibuprofen at discharge. The main outcome was a bone healing complication as evidenced by nonunion, delayed union, or re-displacement on follow-up radiographs. RESULTS: Of the 808 patients included in the final analysis, 338 (42%) were exposed to ibuprofen. Overall, 27 (3%) patients had a bone healing complication; 8 (1%) developed nonunion, 3 (0.4%) developed delayed union, and 16 (2%) developed re-displacement. Ten (3%) patients who were exposed to ibuprofen, and 17 (4%) who were not, developed a bone healing complication (odds ratio 0.8, 95% confidence interval 0.4-1.8; p = 0.61). There was no significant association between ibuprofen exposure and the development of a bone healing complication despite adjustment for potential confounders. CONCLUSION: Children with extremity fractures who are exposed to ibuprofen do not seem to be at increased risk for clinically important bone healing complications.
Asunto(s)
Curación de Fractura/efectos de los fármacos , Fracturas Óseas/tratamiento farmacológico , Ibuprofeno/efectos adversos , Ibuprofeno/farmacocinética , Adolescente , Analgésicos/efectos adversos , Analgésicos/farmacocinética , Analgésicos/uso terapéutico , Distribución de Chi-Cuadrado , Niño , Preescolar , Femenino , Fracturas del Fémur/tratamiento farmacológico , Humanos , Fracturas del Húmero/tratamiento farmacológico , Ibuprofeno/uso terapéutico , Lactante , Masculino , Metatarso/lesiones , Estudios Retrospectivos , Factores de Riesgo , Escápula/efectos de los fármacos , Escápula/lesiones , Fracturas de la Tibia/tratamiento farmacológicoRESUMEN
BACKGROUND: Although vitamin D deficiency has been documented as a frequent problem in studies of young adults, elderly persons, and children in other countries, there are limited data on the prevalence of this nutritional deficiency among healthy US teenagers. OBJECTIVE: To determine the prevalence of vitamin D deficiency in healthy adolescents presenting for primary care. DESIGN: A cross-sectional clinic-based sample. SETTING: An urban hospital in Boston. PARTICIPANTS: Three hundred seven adolescents recruited at an annual physical examination to undergo a blood test and nutritional and activity assessments. MAIN OUTCOME MEASURES: Serum levels of 25-hydroxyvitamin D (25OHD) and parathyroid hormone, anthropometric data, nutritional intake, and weekly physical activity and lifestyle variables that were potential risk factors for hypovitaminosis D. RESULTS: Seventy-four patients (24.1%) were vitamin D deficient (serum 25OHD level, =15 ng/mL [=37.5 nmol/L]), of whom 14 (4.6%) were severely vitamin D deficient (25OHD level, =8 ng/mL [=20 nmol/L]). By using a broader definition (25OHD level, =20 ng/mL [=50 nmol/L]), 129 patients (42.0%) were vitamin D insufficient. Serum 25OHD levels were inversely correlated with parathyroid hormone levels (r = -0.29), and were 24% lower during winter compared with summer. In a final multivariate model, season, ethnicity, milk and juice consumption, body mass index, and physical activity were significant independent predictors of hypovitaminosis D. CONCLUSIONS: Vitamin D deficiency was present in many US adolescents in this urban clinic-based sample. The prevalence was highest in African American teenagers and during winter, although the problem seems to be common across sex, season, and ethnicity.