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.
Management of pain 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
to provide within 1-3 minutes painless needle or cathether insertion for blod drawing. ALGRX
3268 is a single-use disposable system, incorporating a drug cassette and glass 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". Assessment of pain will
be analyzed in each age group 3-7, 8-12, 13-18 and using Wong-Baker FACES pain rating scale.
Children in the middle (8-12) and older (13-18) age groups will also 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 at 15 and 30 minutes following the procedure. AEs/SAEs
will be monitored.
- Outpatient children of either gender [M/F: 1:1] undergoing venipuncture or peripheral
venous cannulation at the antecubital fossa or back of hand. 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
- 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
- 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
- Prior participation in an ALGRX 3268 study.
- Venipuncture at the proposed site within the prior 2 weeks (longer if bruising was