At a glance
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A Study of the Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years
In Brief
A Phase 1 clinical trial evaluating Ketorolac Tromethamine for Postoperative Pain. Completed, enrolled 20 participants across 1 site.
Detailed Summary
This was an open-label PK study in pediatric subjects who had undergone general surgery. Each subject's study participation consisted of a screening visit, a single-dose treatment with intranasal ketorolac (IN) tromethamine, and a follow-up visit. Following surgery, subjects received IN ketorolac 15 mg (weight \< 50 kg) or 30 mg (weight \> or = 50 kg) when pain relief was indicated. For pain not relieved by the study drug, the subjects had access to an opioid analgesic administered by patient-controlled analgesia (PCA). Blood samples for pharmacokinetic analysis were obtained at specified time points following the dose of ketorolac.
Study Details
Timeline
Interventions
Single IN dose of 15 mg ketorolac tromethamine for subjects weighing \<50 kg.
Single IN dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.