Clinical trial: Efficacy and Safety of ALGRX 3268 in Management of Needlestick Pain in Children. (NCT00140088)

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).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 18 Years

Patient description (medical language): A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination.  The boy is going to a school for students with learning disabilities.  The patient was adopted, and his immunizations are up to date.  Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value      Normal Range     Patient Value
Glucose                    90-120 mg/dl     95 mg/dl
BUN (Blood Urea Nitrogen)  7-24 mg/dl       10 mg/dl
Creatinine                 0.7-1.4 mg/dl    0.8 mg/dl
Calcium                    8.5-10.5 mg/dl   9 mg/dl
Sodium                     134-143 mEq/L    135 mEq/L
Potassium                  3.5-4.5 mEq/L    3.7 mEq/L
Chloride                   95-108 mEq/L     98 mEq/L
CO2                        20-30 mEq/L      25 mEq/L
Blood pH                   7.38-7.42        7. 39

Patient description (patient's own words): My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range.

Does the patient match the trial criteria? Entailment