Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132405
Status:
COMPLETED
Last Update Posted:
2005-10-10
First Post:
2005-08-15
Brief Title:
Study of ALGRX 3268 for Needlestick Pain in Children
Sponsor:
AlgoRx Pharmaceuticals
Organization:
AlgoRx Pharmaceuticals
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Study to Determine the Effectiveness and Safety of ALGRX 3268 05 Mg20 Bar at the Back of the Hand in Pediatric Subjects
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Minor needlestick procedures often cause significant pain and distress in children yet interventions to reduce pain are used infrequently ALGRX 3268 is a novel single-use prefilled needle-free dispenser that immediately delivers powdered lidocaine into the epidermis and provides local analgesia in 2 to 3 minutes The purpose of this prospective randomized double-blind and placebo-controlled trial is to determine the efficacy and tolerability of ALGRX 3268 in children aged 3 to 18 years undergoing venipuncture The trial will enroll a total of 306 children aged 3 to 18 years scheduled to undergo venipuncture of the back of the hand at a single study center
Detailed Description:
ALGRX 3268 previously known as PowderJect Dermal Lidocaine is a system for needle-free pain-free epidermal injection of lidocaine powder that provides local anesthesia within 3 minutes to provide painless needle or catheter insertion for blood drawing ALGRX 3268 is a single use disposable system incorporating a drug cassette and gas cylinder into a single hand held device with a button to actuate the system This is a single center randomized double-blind placebo sham controlled single dose parallel group study in pediatric subjects scheduled to undergo venipuncture Three age groups are enrolled 3-7 years 8-12 years and 13-18 years Within each age group subjects are randomized to receive ALGRX 3268 05 mg20 bar or pressure matched placebo Two to 3 minutes after administration of study treatment at the back of the hand venipuncture is performed with either a needleVacutainer needlesyringe or butterfly at the discretion of the investigator Subjects aged 3-7 are asked to rate the pain of venipuncture using the Wong-Baker FACES Pain Rating Scale anchored at 0 for no hurt and 5 for hurts worst Subjects in oldest age group complete a 100 mm visual analogue scale VAS anchored at 0 for no pain and at 100 for extreme pain Subjects in the middle group used both the Wong-Baker FACES scale and the VAS to rate the pain of venipuncture Safety ratings of skin are completed 15 30 and 60 minutes after the procedure
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None