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

Primary Purpose

Procedural Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ALGRX 3268
Sponsored by
AlgoRx Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Procedural Pain focused on measuring Needlestick pain, Venipuncture pain

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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).

Sites / Locations

  • Connecticut Children's Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
August 31, 2005
Last Updated
August 31, 2005
Sponsor
AlgoRx Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00140088
Brief Title
Efficacy and Safety of ALGRX 3268 in Management of Needlestick Pain in Children.
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Confirm the Effectiveness and Safety of ALGRX 3268 in Pediatric Subjects.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
AlgoRx Pharmaceuticals

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Procedural Pain
Keywords
Needlestick pain, Venipuncture pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
504 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ALGRX 3268
Primary Outcome Measure Information:
Title
Child's rating of pain on venipuncture following administration of the study treatment.
Secondary Outcome Measure Information:
Title
Evaluation of pain due to venipuncture in each age group 3-7, 8-12 and 13-18.
Title
Parent/legal guardian's rating of child's pain on an 100 VAS.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Zempsky, MD
Organizational Affiliation
Connecticut Childrne's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26164784
Citation
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.
Results Reference
derived
PubMed Identifier
18450903
Citation
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.
Results Reference
derived

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

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