NCT00132405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for phase_2 pain

Timeline
Completed

Started May 2004

Shorter than P25 for phase_2 pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2005

Completed
Last Updated

October 10, 2005

Status Verified

August 1, 2005

First QC Date

August 15, 2005

Last Update Submit

October 7, 2005

Conditions

Pain

Keywords

Needlestick painVenipuncture painProcedural pain

Outcome Measures

Primary Outcomes (1)

  • Subject's assessment of the pain of venipuncture following administration of study treatment

Secondary Outcomes (1)

  • Parents are asked to assess their child's level of pain of venipuncture on a 100 mm visual analogue scale (VAS)

Interventions

ALGRX 3268DRUG

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Outpatient children of either gender who were to undergo venipuncture at the back of the hand
  • Children must have had 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 mm VAS (ages 8-18).
  • Ages 3 to 7 years; 8 to 12 years; and 13 to 18 years, inclusive
  • Consent forms must have been approved by the appropriate Institutional Review Board (IRB). Signed informed consent must have been granted by the parent or legal guardian and assent to participate should have been sought (either verbally or in writing) from each child.
  • In females of childbearing potential, who in the judgment of the investigator or designee were sexually active, a negative urine pregnancy test must have been documented prior to enrollment. A negative urine pregnancy test was required in all teenage girls over the age of 14 years. Surgically sterile females did 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 judgment 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 tattoos, 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 who planned to become pregnant; 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 two weeks (longer if bruising was apparent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

PainPain, Procedural

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William Zempsky, MD

    Connecticut Children's Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 15, 2005

First Posted

August 22, 2005

Study Start

May 1, 2004

Study Completion

September 1, 2004

Last Updated

October 10, 2005

Record last verified: 2005-08

Locations

US(1)