Phase 1 N=20 Treatment

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

Postoperative Pain

Bottom Line

View on ClinicalTrials.gov: NCT01363076 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Apr 2012

Primary outcome: Primary: Cmax (the Maximum Observed Plasma Concentration) — 1153.9; 1625.3 ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Ketorolac Tromethamine (Drug)
Age: Pediatric · 12+ yrs
Sex: All
Sponsor: Egalet Ltd
Primary completion: Jan 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Cmax (the Maximum Observed Plasma Concentration)	1153.9; 1625.3	—
PRIMARY Tmax (The Time to Maximum Observed Plasma Concentration; ie. The Time at Which Cmax Occured)	0.720; 0.780	—
PRIMARY AUClast (the Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to the Last Quantifiable Timepoint Post-dose)	9308.2; 10662.1	—
PRIMARY AUCinf (the AUC Time From Zero to Infinity, Where Possible)	10590.7; 11949.5	—
PRIMARY AUC 0-24 (the AUC From Time Zero to 24 Hours Post-dose	9600.5; 11317.2	—
PRIMARY t1/2 (the Terminal Half-life, Where Possible)	6.678; 5.031	—
PRIMARY MRT (Mean Residence Time)	9.664; 6.727	—

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 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

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Data sourced from ClinicalTrials.gov (NCT01363076). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.