PURPOSE: The goal of this study was to determine if a @entity70061 powder intradermal system designed to provide cutaneous @entity1337 is efficacious, safe, and tolerable for pediatric subjects compared with a sham placebo system. METHODS: COMFORT-004, A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Confirm the Effectiveness and Safety of ALGRX 3268 in Pediatric Subjects, was a single-dose, parallel group study of @entity1 undergoing venipuncture or peripheral venous cannulation at the antecubital fossa or back of the hand. Included were subjects (3-18 years) in 3 age groups: 3-7, 8-12, and 13-18 years. Excluded were those with recent similar procedures or with implantable devices or skin pathologies at the anatomical site, insufficient @entity73 , or @entity566 to local anesthetics or adhesives. Subjects were randomized to receive the needle-free powder @entity3303 delivery system (active system, 0.5 mg of @entity3303 /21    1 bar of pressure [n = 269]) or sham placebo (n = 266) 1-3 minutes before venipuncture or peripheral venous cannulation. Analgesic efficacy was assessed @entity1 self-report of @entity158 (Wong-Baker FACES Pain Rating Scale [3-18 years] and visual analog scale [VAS; 8-18 years]) and parental observational VAS. Safety assessments included adverse events (AEs) and relationship to study treatment. Skin signs and symptoms were graded numerically. Wong-Baker FACES scores, VAS, and parental VAS were analyzed by using an ANOVA model. Responder ratings and success rates were compared by using a Cochran-Mantel-Haenszel test stratified according to center, age group, and body site. FINDINGS: The active system group had significantly (P = 0.0022) less @entity158 compared with the sham placebo in all age groups combined according to the modified Wong-Baker FACES scale. Secondary efficacy analyses found that the active system resulted in less @entity158 as assessed by subjects' VAS @entity158 assessments aged 8-18 years (P = 0.1856), responder analysis (P = 0.054), and parents' VAS assessments (P = 0.002). Venous procedures were successful in 95.5% and 96.2% of the active system and sham placebo groups, respectively. Treatment-emergent AEs, most commonly @entity390 and/or emesis, were not significant between groups. There were no serious AEs. The active system group had significantly more minor erythema and @entity548 /petechiae. IMPLICATIONS: The needle-free powder @entity3303 delivery system was well tolerated and produced superior @entity1337 compared with sham placebo when administered 1-3 minutes before pediatric venipuncture or peripheral venous cannulation. Treatment-related AEs occurred primarily at the administration site and were infrequent, generally mild, and resolved without sequelae. ClinicalTrials.gov identifier: NCT00140088.

Safety and Efficacy of a Needle-free Powder XXXX Delivery System in Pediatric @entity1 Undergoing Venipuncture or Peripheral Venous Cannulation: Randomized Double-blind COMFORT-004 Trial.

@entity1 :: ('9606', 'Species') :: ['children', 'patient'] @entity390 :: ('MESH:D009325', 'Disease') :: ['nausea'] @entity548 :: ('MESH:D006470', 'Disease') :: ['hemorrhage'] @entity70061 :: ('CHEBI:60791', 'Chemical') :: ['lidocaine hydrochloride monohydrate'] @entity566 :: ('MESH:D006967', 'Disease') :: ['allergies'] @entity73 :: ('MESH:D003072', 'Disease') :: ['cognitive skills'] @entity1337 :: ('MESH:D000699', 'Disease') :: ['analgesia'] @entity3303 :: ('MESH:D008012', 'Chemical') :: ['lidocaine'] @entity158 :: ('MESH:D010146', 'Disease') :: ['pain', 'venous access pain']
@entity3303 :: (MESH:D008012,Chemical) :: ['Lidocaine']
