Pain management due to minor procedures such as venipuncture or peripheral venous canulation still represents an unmet medical need, especially in pediatric setting. Current therapeutic products have a relatively delayed onset of analgesia of at least 10 minutes; moreover the most used products require application with at least 30-60 minutes prior to procedure. Development of ALGRX 3268 is aimed at addressing this unmet need in management of pain associated with needlestick procedures.~ALGRX 3268 (Previously known as PowderJect(R) Dermal Lidocaine) is used for local anesthesia within 3 minutes to provide painless needle or cathether insertion for blood drawing. ALGRX 3268 is a single-use disposable system, incorporating a drug cassette and cylinder into a single hand held device, with a button to actuate the system.~The purpose of this phase III, multicenter, prospective, randomized, double-blind, placebo-controlled study is to investigate the efficacy, safety and tolerability of ALGRX 3268 versus placebo in pediatric patients 3 to 18 years of age, who undergo venipuncture or peripheral venous canulation procedures. The trial will enroll approximate 504 evaluable subjects at centers located in the US.~Three age groups are enrolled: 3-7 years, 8-12 years, 13-18 years. Within each age group subjects are randomized to receive ALGRX 3268 0.5 mg/20 bar or pressure matched placebo. One to 3 minutes after administration of study treatment at the back of the hand or antecubital fosa, venipuncture is performed with a needle/Vacutainer, needle/syringe or butterfly, at the discretion of the investigator.~Subjects 3-18 years are asked to assess pain on venipuncture using Wong-Baker FACES pain rating scale, anchored at 0 for no hurt and 5 for hurts worst.~Children in the middle (8-12) and older (13-18) age groups will additionally rate pain at the ACF and BOH using a 100 mm VAS anchored at 0 for no pain and at 100 for extreme pain. Parent/legal guardian will evaluate child's level of pain on a 100 mm VAS anchored at 0, for no pain, and at 100 for extreme pain.~Safety ratings of skin are completed immediately prior, after, at 15 and 30 minutes following the procedure. All AEs/SAEs will be monitored.
Minor needlestick procedures often cause significant pain and distress in pediatric patients yet interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use, prefilled, needle-free product that immediately delivers powdered lidocaine into the epidermis and provides local analgesia in 2-3 minutes. The purpose of this phase III, prospective, randomized, double-blind, placebo-controlled study is to investigate the efficacy, safety and tolerability of ALGRX 3268 versus placebo in pediatric patients aged 3 to 18 years undergoing venipuncture or peripheral venous canulation procedures. The trial will enroll approximate 504 evaluable subjects at centers located in the US.