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

NCT ID: NCT01363076

Last Updated: 2017-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-05-31

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.

Conditions

Postoperative Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ketorolac Tromethamine (15 mg)

Ketorolac Tromethamine - single dose (15 mg) administered intranasally (IN) for subjects weighing \<50 kg.

Group Type: EXPERIMENTAL

Ketorolac Tromethamine

Intervention Type: DRUG

Single IN dose of 15 mg ketorolac tromethamine for subjects weighing \<50 kg.

Ketorolac Tromethamine (30 mg)

Ketorolac Tromethamine - single dose (30 mg) administered intranasally (IN) for subjects weighing ≥50 kg.

Group Type: EXPERIMENTAL

Ketorolac Tromethamine

Intervention Type: DRUG

Single IN dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.

Interventions

Ketorolac Tromethamine

Single IN dose of 15 mg ketorolac tromethamine for subjects weighing \<50 kg.

Intervention Type: DRUG

Ketorolac Tromethamine

Single IN dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Egalet Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lincoln Bynum, MD

Role: STUDY_CHAIR

ICON Developmental Solutions

Locations

Stanford University Medical Center

Stanford, California, United States

Countries

United States

Other Identifiers

ROX 2006-02

Identifier Type: -

Identifier Source: org_study_id