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

This study has been completed.
Information provided by:
Luitpold Pharmaceuticals Identifier:
First received: May 9, 2011
Last updated: September 14, 2012
Last verified: September 2012

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.

Condition Intervention Phase
Postoperative Pain Drug: Ketorolac tromethamine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-blind, Randomized Study of the Safety, Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain

Resource links provided by NLM:

Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • Total Morphine Sulfate (MS) Use in Milligrams by Patient-controlled Analgesia (PCA) Through 24 Hours [ Time Frame: 8-hour intervals from the start of dosing through 24 hours ]

Secondary Outcome Measures:
  • Total MS Use in Milligrams by PCA From the Start of Dosing Through 48 Hours [ Time Frame: 8-hour intervals from the start of dosing through 48 hours ]
  • Total MS Use in Milligrams by PCA From 24 Hours After the Start of Dosing Through 48 Hours [ Time Frame: 8-hour intervals from 24 hours after the start of dosing through 48 hours ]
  • Pain Intensity Difference (PID) Scores [ Time Frame: 6 hours after study drug administration ]
    Ratings of Pain Intensity (PI) were made using a 100-mm Visual Analog Scale (VAS) on which 0 = no pain and 100 = worst pain possible. PID was calculated by subtracting the posttreatment score from the baseline score, where the baseline score was the PI rating made prior to the first dose of study medication.

Enrollment: 127
Study Completion Date: October 2007
Arms Assigned Interventions
Experimental: Ketorolac tromethamine (5%) Drug: Ketorolac tromethamine
10 mg Intranasal (2 x 100 uL of a 5% solution)
Experimental: Ketorolac tromethamine (15%) Drug: Ketorolac tromethamine
30 mg Intranasal (2 x 100 uL of a 15% solution)
Placebo Comparator: Placebo Drug: Placebo


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men or women, age 18 years or older
  • Body weight > or = 100 pounds (45.4 kg) and < or = 300 pounds (136.1 kg)
  • Women of childbearing potential must have had a negative serum pregnancy test result prior to entry into the study
  • Able to provide written informed consent
  • At least moderate pain as determined by a PI score of > 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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Please refer to this study by its identifier: NCT01351090

New Zealand
Waikato Clinical Research
Hamilton, New Zealand
Sponsors and Collaborators
Luitpold Pharmaceuticals
Study Chair: Lincoln Bynum, MD ICON Development Solutions
  More Information

Responsible Party: David Bregman, M.D., Ph.D., Luitpold Pharmaceuticals, Inc. Identifier: NCT01351090     History of Changes
Other Study ID Numbers: ROX 2001-03
Study First Received: May 9, 2011
Results First Received: September 14, 2012
Last Updated: September 14, 2012

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ketorolac Tromethamine
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on August 23, 2017