Summary:
This is a multicenter, single-dose study in children 12 to <17 years of age, 6 to <12 years of age, 2 to <6 years of age who are scheduled for elective open inguinal hernia repair. Subjects will then undergo an open inguinal hernia repair under general anesthesia according to the investigator’s standard surgical practice on Day 1. The cost of surgery, anesthesia, and study medicatons are covered by the study Sponsor. Health Insurance is not required. Enrollment in this study will start with the oldest age group (12 to <17 years) and will continue in a step-wise fashion until appropriate doses are established for all 3 pediatric age groups (12 to <17 years, 6 to <12 years, 2 to <6 years).
Children in each age group who are randomized to investigational product. Study drug will be administered prior to wound closure. After completion of the surgical procedure, all subjects will be transferred to the post anesthesia care unit (PACU) where they will remain for at least 3 hours. While in the PACU subjects will be continuously monitored for safety (ie, vital signs, oxygen saturation levels, 3-lead ECGs, and AEs and SAEs possibly related to bupivacaine toxicity). Subjects may receive rescue medication (opioid or non-opioid) upon request and at the discretion of the investigator for the management of breakthrough pain. Subjects may receive an antiemetic at the discretion of the investigator for the management of nausea or vomiting. After the initial 3 hour period, subjects who are deemed stable can be discharged to the hospital ward. Subjects will remain housed in the hospital ward for at least 48 hours.
Qualified Participants Must:
• Be male or female 2-17 years of age scheduled for an elective open inguinal hernia repair that will be performed according to standard surgical technique under general anesthesia
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Females must be non-pregnant and not lactating
Qualified Participants May Receive:
Surgery Free of Cost
Study Medications Free of Cost
Monitoring by Medical Personal (MD's, RN's, Coordinators) free of charge
Compensation for Time and Travel.