Status:
COMPLETED
Efficacy and Safety of ALGRX 3268 in Management of Needlestick Pain in Children.
Lead Sponsor:
AlgoRx Pharmaceuticals
Conditions:
Procedural Pain
Eligibility:
All Genders
3-18 years
Phase:
PHASE3
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, needl...
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 ha...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT00140088
Start Date
December 1 2004
End Date
April 1 2005
Last Update
September 1 2005
Active Locations (1)
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1
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106