RESEARCH IN PRACTICE

AT A GLANCE

Intranasal (IN) ketorolac reduces the need for postoperative opioids1
Even though patients in the intranasal ketorolac group used less morphine,
they experienced superior pain relief1

Moodie JE, Brown CR, Bisley EJ, Weber HU, Bynum L. The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. Anesth Analg. 2008;107(6):2025-2031.

Pharmacokinetic evaluation of intranasal ketorolac in a phase 1 trial indicated that the compound was rapidly absorbed, with a half-life of 5 to 6 hours and a bioavailability of approximately 70% compared with intramuscular (IM) administration. The time to maximum plasma concentration for the IN formulation (0.75 hours) was the same as the IM formulation, but shorter than that reported for oral administration (0.90 hours). From these results, an IN dose of 31.5 mg was considered appropriate for further development, since the plasma levels from this dose lay between those achieved by IM administration of 15 and 30 mg, which have demonstrated good efficacy. In an effort to show a dose response, a comparator dose of 10 mg was chosen. Ten milligrams is the dose recommended for oral administration.

Double-blind, placebo-controlled study to evaluate the safety and efficacy of multiple doses of intranasal ketorolac tromethamine for postoperative pain

127 surgical patients with postoperative signs of discomfort were given an intravenous (IV) opioid titrated to comfort1
When patients were alert enough to complete pain assessments and had a pain intensity rating of at least 40 on a 100-mm visual analog scale, they received a dose of IN ketorolac 10 mg or 31.5 mg, or placebo, every 8 hours for 40 hours1
Patients were assessed at 30 minutes, hourly for 6 hours, at 8 hours, then every 4 hours through 48 hours after receiving the study drug1
Patient-controlled IV morphine provided supplemental analgesia

IN ketorolac 31.5 mg demonstrated significant analgesic efficacy compared
with IN ketorolac 10 mg and placebo1
Patients receiving 31.5 mg of ketorolac used significantly less morphine
(37.8 mg) during the first 24 hours than did the placebo group (56.5 mg)
and the 10-mg ketorolac group (54.3 mg)1
Over 48 hours, the 31.5-mg ketorolac group used significantly less morphine than the placebo group1
Summed pain intensity differences (SPID) at 4 hours and 6 hours significantly favored the 31.5-mg ketorolac group over the other groups1
Most adverse effects were mild or moderate; the most common were pyrexia
and nausea, both occurring in 50.4% of patients overall1
Adverse events typically associated with NSAID use (ie, abdominal pain, dyspepsia, hematemesis, fluid retention, and oliguria) were all reported
by 3 or fewer subjects in any group1

A nasal spray formulation provides advantages for the postoperative patient who is unable to take oral pain medications or needs more potent analgesia than is provided by oral products, while avoiding the inconvenience of an IV line and the discomfort of IM injections.

The study results demonstrated that the 31.5 mg dose showed evidence of analgesic efficacy and reduced use of opioids that warranted further investigation.

Continue the discussion Review safety and tolerability of SPRIX® Opioids: A Closer Look

Safety With SPRIX® Review tolerability data and important safety information

Well Absorbed by the Nasal Mucosa Peak plasma concentration in as little as 30 minutes

REFERENCE:

Moodie JE, Brown CR, Bisley EJ, Weber HU, Bynum L. The safety and analgesic efficacy of intranasal ketorolac in patients with postoperative pain. Anesth Analg. 2008;107(6):2025-2031.