NCT01363076

The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years

A Study of the Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Egalet Ltd · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Pain

Interventions

Type	Name	Description
DRUG	Ketorolac Tromethamine	Single IN dose of 15 mg ketorolac tromethamine for subjects weighing \<50 kg.
DRUG	Ketorolac Tromethamine	Single IN dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-01-01
• Completion: 2008-05-01
• First posted: 2011-06-01
• Last updated: 2017-03-16
• Results posted: 2012-04-09

Locations

1 site across 1 country: United States