This is a Phase 2 study in pediatric subjects undergoing inguinal herniorrhaphy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.
Bupivacaine HCl 0.25% (without epinephrine) (total dose not to exceed 75 mg).
Dose to be determined from Cohort 1.
Area under the concentration-time curve (AUC) from Time 0 extrapolated to infinity (AUCinf)
Time frame: 72 hours
Maximum concentration (Cmax)
Time frame: 72 hours
Time of occurrence of maximum concentration (Tmax)
Time frame: 72 hours
Adolescents ≥12 to <17 years of age (Cohort 1): area under the curve (AUC) of the Numeric Rating Scale of pain intensity scores with activity (NRS-A)
Time frame: 72 hours
Children ≥6 to <12 years of age (Cohort 2): AUC of the Faces-Pain-Scale (FPS)-Revised pain intensity scores
Time frame: 72 hours
Children ≥3 to <6 years of age (Cohort 3): AUC of the Faces, Legs, Activity, Cry, Consolability (FLACC) scale pain intensity scores
Time frame: 72 hours
Total postoperative opioid consumption (in IV morphine milligram equivalents)
Time frame: 72 hours
Proportion of subjects who are opioid-free
Time frame: 72 hours
AUC of the Numeric Rating Scale pain intensity scores at rest (NRS-R)
Time frame: 72 hours
Proportion of subjects who do not receive an opioid prescription at discharge.
Time frame: 72 hours
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Dose to be determined from Cohorts 1 and 2.
Dose to be determined from Cohort 1 Part A.
Applicator for instillation.