Efficacy and Safety of ALGRX 3268 in Children Undergoing Minor Needle-Stick Procedures.
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
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.
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Confirm the Effectiveness and Safety of ALGRX 3268 in Pediatric Subjects.
Eligibility Criteria
- - Outpatient children of either gender [M/F: 1:1] undergoing venipuncture or peripheral venous cannulation at the ATF or BOH. Children must have sufficient cognitive skills to identify faces depicting extremes of pain on the Wong-Baker FACES Pain Rating Scale, (ages 3-12) and/or the extremes of pain on a 100 VAS (ages 8-18). - Ages 3-7, 8-12, 13-18 years inclusive. Informed consent forms must have been approved by the appropriate IRB. Signed informed consent must have been granted by the parent/legal guardian and assent to participate should have been sought (either verbally or in writting) from each child. - In females of childbearing potential who in the judgement of the investigator or designee were sexually active, a negative preganancy test must have been documented prior to enrollment. A negative urine preganancy test was required in all teenage girls over the age of 14 years. Surgically sterile females do not require a pregnancy test.
- - Previous history of allergic reactions to any local anesthetic. Any medical condition or instability that in the judgement of the investigator might have adversely impacted the conduct of the study and the collection of data. - Subjects in whom the investigator determined that venipuncture could not be accomplished cleanly. - Active local infection or other skin pathology on the dorsum of the hand. Subjects with tattos, surgical scars, ports, implantable devices or a skin condition that may have interfered with placement of study treatment or skin site assessments. - Female subjects who were pregnant or lactating; females with a positive serum or urine pregnancy test; females of childbearing potential who were not using adequate contraception. - Prior participation in an ALGRX 3268 study. - Venipuncture at the proposed site within the prior 2 weeks (longer if bruising was apparent).
Investigator(s)
View on ClinicalTrials.gov
