Related Experiment Video
Updated: Jun 21, 2026
02:26
Intracranial Pharmacotherapy and Pain Assays in Rodents
Published on: April 9, 2019
Intranasal ketorolac for postoperative pain: a phase 3, double-blind, randomized study
Colin Brown1, John Moodie, Eileen Bisley
1Waikato Clinical Research, Waikato Hospital, Department of Anaesthesia, Hamilton, New Zealand.
Pain Medicine (Malden, Mass.)
|July 15, 2009
Summary
Intranasal ketorolac effectively reduced postoperative pain and morphine use in inpatients. This non-opioid pain management option showed good tolerability, warranting further study for outpatient settings.
Area of Science:
- Pain Management
- Pharmacology
- Clinical Research
Background:
- Postoperative pain management often relies on opioids, which carry risks of side effects and dependence.
- Non-opioid analgesics offer an alternative, but their efficacy in moderate-to-severe pain requires robust evaluation.
- Intranasal (IN) drug delivery presents a convenient route for rapid absorption and potential for improved patient compliance.
Purpose of the Study:
- To evaluate the analgesic efficacy and tolerability of intranasal ketorolac in patients experiencing moderate-to-severe postoperative pain.
- To compare the effectiveness of IN ketorolac against a placebo in a randomized, double-blind, controlled setting.
- To assess the impact of IN ketorolac on patient-controlled analgesia (PCA) morphine consumption.
Main Methods:
- A randomized, double-blind, placebo-controlled study involving 300 postoperative patients (199 on IN ketorolac, 101 on placebo).
- Patients received either IN ketorolac (31.5 mg) or placebo three times daily for up to 5 days, with PCA morphine as needed.
- A single-dose phase assessed pain reduction after 3 hours post-PCA removal, with doses administered when Visual Analog Scale (VAS) scores were ≥40.
Main Results:
- The primary efficacy endpoint, summed pain intensity difference at 6 hours post-single dose, was significantly greater with IN ketorolac versus placebo (83.3 vs 37.2, P < 0.007).
- Morphine consumption was reduced by 34% in the IN ketorolac group compared to placebo.
- Adverse event incidence was similar (approx. 98%) between groups; nausea and vomiting were most common. Nasal irritation occurred more frequently with ketorolac (24% vs 2%).
Conclusions:
- Intranasal ketorolac demonstrates significant analgesic efficacy and good tolerability for moderate-to-severe postoperative pain in inpatients.
- The convenience of IN administration suggests potential utility in ambulatory care settings.
- Further research is recommended to explore the application of IN ketorolac in non-hospitalized patients.