Efficacy and Safety of ALGRX 3268 in Management of Needlestick Pain in Children.

NCT00140088 | Completed Phase 3

• 1 other identifier: 3268-3-003-1
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Procedural Pain

Keywords

Needlestick pain; Venipuncture pain

Outcome Measures

Primary Outcomes (1)

• Child's rating of pain on venipuncture following administration of the study treatment.

Secondary Outcomes (2)

• Evaluation of pain due to venipuncture in each age group 3-7, 8-12 and 13-18.

• Parent/legal guardian's rating of child's pain on an 100 VAS.

Interventions

ALGRX 3268 DRUG

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 test.

You may not qualify if:

• 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).

Sponsors & Collaborators

• AlgoRx Pharmaceuticals: lead

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Related Publications (2)

• Schmitz ML, Zempsky WT, Meyer JM. Safety and Efficacy of a Needle-free Powder Lidocaine Delivery System in Pediatric Patients Undergoing Venipuncture or Peripheral Venous Cannulation: Randomized Double-blind COMFORT-004 Trial. Clin Ther. 2015 Aug;37(8):1761-72. doi: 10.1016/j.clinthera.2015.05.515. Epub 2015 Jul 8.

  PMID: 26164784 DERIVED

• Zempsky WT, Bean-Lijewski J, Kauffman RE, Koh JL, Malviya SV, Rose JB, Richards PT, Gennevois DJ. Needle-free powder lidocaine delivery system provides rapid effective analgesia for venipuncture or cannulation pain in children: randomized, double-blind Comparison of Venipuncture and Venous Cannulation Pain After Fast-Onset Needle-Free Powder Lidocaine or Placebo Treatment trial. Pediatrics. 2008 May;121(5):979-87. doi: 10.1542/peds.2007-0814.

  PMID: 18450903 DERIVED

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• William Zempsky, MD

  Connecticut Childrne's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 1, 2005
• Study Start: December 1, 2004
• Study Completion: April 1, 2005
• Last Updated: September 1, 2005

Record last verified: 2005-08

Locations

US (1)