The Pharmacokinetics of Ketorolac Tromethamine Administered Intranasally (IN) for Postoperative Pain in Children Aged 12 Through 17 Years
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Ketorolac Tromethamine; Ketorolac Tromethamine
Intervention description: 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.
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 12 through 17 years

          -  Body weight > or = 30 kg and < or = 100 kg

          -  Female subjects of childbearing potential must have a negative serum or urine
             pregnancy test result prior to entry into the study

          -  A legal representative able to provide written informed consent

          -  Willing and able to comply with all testing and requirements defined in the protocol

          -  Willing and able to complete the posttreatment visit

        Exclusion Criteria:

          -  Allergy or sensitivity to ketorolac or ethylene diamine tetraacetic acid (EDTA)

          -  Allergic reaction to aspirin or other NSAIDs

          -  Had an upper respiratory tract infection or other respiratory tract condition (eg,
             active allergic rhinitis) that could interfere with the absorption of the nasal spray
             or with the assessment of AEs

          -  Use of any IN product within 24 hours prior to study entry

          -  Clinically significant abnormality on screening laboratory tests

          -  History of cocaine use resulting in nasal mucosal damage

          -  History of peptic ulcer disease or gastrointestinal bleeding

          -  Had advanced renal impairment or a risk for renal failure due to volume depletion

          -  A history of any other clinically significant medical problem, which in the opinion of
             the investigator would interfere with study participation

          -  Participation within 30 days of study entry or within 5 times the half-life, whichever
             is longer, in another investigational drug study

          -  Allergy or significant reaction to opioids

          -  Was pregnant or breastfeeding

          -  Previously participated in this study

          -  The surgical procedure involved head, neck, oral, or nasal surgery