Low-Dose Oral Midazolam Reduces Fear and Distress During Needle Procedures in Children With Cancer

Background. Children with cancer often mention needle procedures as the most frightening, distressing, and sometimes painful aspect of the disease and treatment. The aim was to investigate whether children experience less fear, distress, and/or pain according to parents, nurses, and children >= 7 years of age when they receive oral midazolam versus placebo before a needle is inserted in a subcutaneously implanted intravenous port. Procedure. Fifty children 1-18 years of age who were being treated in a pediatric oncology and hematology setting were included consecutively when undergoing routine needle insertion into an intravenous port. All children were Subjected to one needle insertion in this randomized, triple-blind, placebo-controlled study in which orally administered midazolam (n = 24) 0.3 mg/kg body weight (maximum 10 mg) was compared with placebo (n = 26). Parents, nurses, and children >= 7 years reported the patients' fear, distress, and pain on 0-100 mm Visual Analogue Scales. Results. Fear was lower in the midazolam group according to parents (P = 0.001), nurses (P = 0.001), and children (P = 0.015). Parents and nurses also reported lower distress (P = 0.020 and 0.007, respectively). Post hoc analyses indicated that the effects were more pronounced in Younger children (<7 years of age). Conclusion. Low-dose oral midazolam was effective in reducing fear and distress in pediatric oncology patients, especially in younger children, undergoing subcutaneous port needle insertion. Pediatr Blood Cancer 2009;53:1200-1204. (C) 2009 Wiley-Liss, Inc.