Phase 2 Completed N=127 Randomized Double-blind Treatment

Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine (IN) for Postoperative Pain

Postoperative Pain

Source: ClinicalTrials.gov NCT01351090 ↗

Enrolled (actual)

127

Serious AEs

7.1%

Results posted

Oct 2012

Primary outcomePrimary: Total Morphine Sulfate (MS) Use in Milligrams by Patient-controlled Analgesia (PCA) Through 24 Hours — 54.32; 37.77; 56.45 mg

Summary

This was a randomized, double blind, placebo-controlled study in subjects who have undergone major surgery. Each subject's study participation consisted of a screening visit, a 2-day treatment period, and a follow-up visit. Following surgery, subjects were randomly assigned to receive intranasally (IN) ketorolac 10 mg, IN ketorolac 30 mg, or placebo when the pain intensity (PI) rating equaled at least 40 on a 100-mm visual analog scale (VAS). Thereafter, subjects received study drug every 8 hours, with the last dose given at 40 hours. For pain not relieved by the study drug, the subjects had access to morphine sulfate (MS) administered via patient controlled analgesia (PCA). The primary objective was to evaluate the analgesic efficacy of multiple intranasal (IN) doses of ketorolac over 2 days. The secondary objective was to evaluate the safety and tolerability of this dosing regimen.

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Morphine Sulfate (MS) Use in Milligrams by Patient-controlled Analgesia (PCA) Through 24 Hours	54.32; 37.77; 56.45	—
SECONDARY Total MS Use in Milligrams by PCA From the Start of Dosing Through 48 Hours	78.66; 61.39; 87.87	—
SECONDARY Total MS Use in Milligrams by PCA From 24 Hours After the Start of Dosing Through 48 Hours	28.25; 23.11; 32.61	—
SECONDARY Pain Intensity Difference (PID) Scores	34.1; 38.9; 29.1	—

Eligibility Criteria

Inclusion Criteria

Men or women, age 18 years or older
Body weight > or = 100 pounds (45.4 kg) and or = 40 mm on a 100-mm VAS
Expected to remain in the hospital for at least 48 hours
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 nonsteroidal anti-inflammatory drug (NSAIDs)
Current upper respiratory tract infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with the assessment of adverse events
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
Active peptic ulcer disease, recent (defined as within 6 months) gastrointestinal bleeding or perforation, or a history of peptic ulcer disease or gastrointestinal bleeding
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
Pregnancy or breastfeeding
Previous participation in this study

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Data sourced from ClinicalTrials.gov (NCT01351090). 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. Informational only — not medical advice.