Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
A multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years of age,
and 2 to <6 years of age who are scheduled for elective open inguinal hernia repair.
Enrollment in this study will start with the oldest age group (12 to <17 years) and will
continue in a stepwise fashion until appropriate doses are established for all 3 pediatric
age groups (12 to <17 years, 6 to <12 years, 2 to <6 years).
Phase
Phase 3
Funding Agency/Sponsor
Industry
Disease
Pediatric
Enrollment Eligibility
Inclusion Criteria:
- Be a male or female 2 to <17 years of age.
- Be eligible for an elective open inguinal hernia repair that will be performed
according to standard surgical technique under general anesthesia.
- Be premenarche or have a serum confirmed negative pregnancy test at screening and a
negative urine pregnancy test before surgery on day 1, if an adolescent female of
childbearing potential.
- Be willing and able to cooperate with all the requirements of the study.
- Be able to speak and understand English or Spanish.
- Have a legally authorized representative (eg, parent, guardian) who is able to read,
speak, and understand English or Spanish and who will voluntarily sign and date a
parental permission/informed consent form that is approved by the Institutional Review
Board/Independent Ethics Committee/Human Research Ethics Committee (IRB/IEC/HREC).
- Be willing to sign an assent (if appropriate dependent upon the child's age,
understanding, and IRB requirements), before the conduct of any study procedure.
Exclusion Criteria:
- Has a known hypersensitivity to amide local anesthetics, bovine products, or to
inactive ingredients of the study drugs.
- Requires any additional surgical procedures, either related or unrelated to the
scheduled surgery (ie, open inguinal hernia surgery), during the same hospitalization.
- Requires epidural or spinal blockade perioperatively.
- Is required to receive neuraxial (spinal or epidural) opioid analgesics during the
study.
- Has undergone major surgery within 3 months of the scheduled surgery or plans to
undergo another surgical procedure within the 30-day postoperative period.
- Has known or suspected history of drug abuse or misuse or evidence of tolerance or
physical dependency on opioid analgesics or sedative-hypnotic medications.
- Has participated in a clinical trial (investigational or marketed product) within 30
days before surgery.
- Has any clinically significant medical history or condition (eg, unstable cardiac,
neurological, immunological, renal, hepatic, or hematological disease or any other
condition) that in the opinion of the investigator, substantially increases the risk
associated with the subject's participation in the protocol or compromises the
scientific objectives of the study.