drugset / Trial / NCT01819610
Pharmacokinetics, Safety, and Efficacy of SPRIX in 12 to 17 Year Old Patients vs. Adult Patients Undergoing Open Surgical Procedures
NaSingle-groupOpen-labelTreatment
Summary
A SPRIX trial in pediatric subjects vs. adults undergoing open surgical procedures resulting in at least a moderate pain level. Subjects will receive SPRIX and blood samples will be collected for pharmacokinetic (PK) assessment. Subjects will also be assessed on the safety and efficacy of SPRIX.
Timeline
- Start
- 2013-02
- Primary completion
- 2014-03
- Completion
- 2014-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SPRIX (intranasal ketorolac tromethemine) | Unknown | — | Intranasal |
Indications
No indication recorded.