Conditions: Postoperative Pain
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 20
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Ketorolac Tromethamine - single dose (15 mg) administered intranasally (IN) for subjects weighing \<50 kg. arm 2: Ketorolac Tromethamine - single dose (30 mg) administered intranasally (IN) for subjects weighing ≥50 kg.

Interventions: intervention 1: Ketorolac Tromethamine intervention 2: Ketorolac Tromethamine
Intervention descriptions: intervention 1: Single IN dose of 15 mg ketorolac tromethamine for subjects weighing \<50 kg. intervention 2: Single IN dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.

Protocol document: